A Listening Ear a Listening Treatment the Treatment in Interventions Psychotherapeutic

21-12-2020 14:0921-12-2020 14:09 @ Stijn Gisquiere @ Stijn em. Paul Van de Heyning, Antwerp, 2021 c De Bodt, & Prof. dr. Frank Declau f. dr. Annick Gilles, Prof. dr. TINE LUYTEN Prof. dr. em. Mar OF CHRONIC SUBJECTIVE TINNITUS SUBJECTIVE OF CHRONIC Thesis submitted for the degree of Doctor of of of Doctor for the degree Thesis submitted Medical Sciences at the University of Antwerp Supervisors: Pro A LISTENING EAR A LISTENING TREATMENT THE TREATMENT IN INTERVENTIONS PSYCHOTHERAPEUTIC

A LISTENING EAR. PSYCHOTHERAPEUTIC INTERVENTIONS IN THE TREATMENT OF CHRONIC SUBJECTIVE TINNITUS Tine Luyten @ Stijn Gisquiere @ Stijn @Stijn Gisquiere @Stijn DEPT. OF TRANSLATIONAL NEUROSCIENCES OF TRANSLATIONAL DEPT. FACULTY OF MEDICINE AND HEALTH SCIENCES OF MEDICINE AND HEALTH FACULTY 147260 Luyten R14 OMS.indd 2-3147260 Luyten R14 OMS.indd 2-3

Illustrations: Stijn Gisquière Printing: Ridderprint | www.ridderprint.nl ISBN: 978-94-6416-364-3

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Faculty of Medicine and Health Sciences

A listening ear. Psychotherapeutic interventions in the treatment of chronic, subjective tinnitus

Een luisterend oor. Psychotherapeutische interventies in de behandeling van chronische, subjectieve tinnitus

Proefschrift voorgelegd tot het behalen van de graad van Doctor in de Medische Wetenschappen aan de Universiteit van Antwerpen te verdedigen door

Tine Luyten

Supervisors: Prof. dr. Annick Gilles, Prof. dr. em. Paul Van de Heyning, & Prof. dr. em. Marc De Bodt | Co-supervisor: Prof. dr. Frank Declau

Antwerpen, 2021

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147260 Luyten BNW.indd 4 22-12-2020 13:54 Examining Committee

SUPERVISORS

Prof. dr. Annick Gilles – Supervisor

Department of Otorhinolaryngology and Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium Faculty of Medicine and Health Sciences, Campus Drie Eiken, University of Antwerp, Antwerp, Belgium Department of Education, Health & Social Work, University College Ghent, Ghent, Belgium

Prof. dr. em. Paul Van de Heyning – Supervisor

Prof. dr. em. Marc De Bodt – Supervisor

Prof. dr. Frank Declau - Co – Supervisor

Department of Otorhinolaryngology and Head and Neck Surgery, GZA Hospitals, Antwerp, Belgium Faculty of Medicine and Health Sciences, Campus Drie Eiken, University of Antwerp (UA), Antwerp, Belgium

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147260 Luyten BNW.indd 6 22-12-2020 13:54 MEMBERS OF THE JURY

Prof. dr. Olivier M. Vanderveken - Internal jury member

Prof. dr. Manuel Morrens - Internal jury member

Faculty of Medicine and Health Sciences, Collaborative Antwerp Psychiatric Institute (CAPRI), Campus Drie Eiken, University of Antwerp (UA), Antwerp, Belgium Scientific Institute for Neuropsychiatric and Psychopharmacological Studies (SINAPS), University Psychiatric Hospital Duffel, VZW Emmaüs, Duffel, Belgium

Prof. dr. David Baguley - External jury member

President of the British Tinnitus Association, UK NIHR Nottingham Biomedical Research Center, University of Nottingham, UK Department of Hearing Sciences, Division of Clinical Neurosciences, School of Medicine, University of Nottingham, UK

Prof. dr. Berthold Langguth - External jury member

Head of the Multidisciplinary Tinnitus Clinic of the University of Regensburg, Regensburg, Germany Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany

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147260 Luyten BNW.indd 8 22-12-2020 13:54

‘ Ring the bells that still can ring

Forget your perfect offering

There is a crack, a crack in

everything

That's how the light gets in.’

Leonard Cohen - Anthem

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147260 Luyten BNW.indd 10 22-12-2020 13:54 Summary

Tinnitus, often referred to as ringing in the ears, is defined as the perception of sound

without the presence of an external auditory input i.e. a phantom percept (De Ridder,

Elgoyhen et al. 2011). Up to 8 - 20% of people worldwide receive the diagnosis of chronic

tinnitus when this symptom is present for more than three months. About 1 - 3% of this

population experience tinnitus as debilitating and seek medical help (Baguley, McFerran

et al. 2013).

Patients describe hearing wheezing, buzzing or hissing sounds, which can lead to

extensive psychological burden and have a serious impact on the quality of life. A high

comorbidity with insomnia, depression, and anxiety is observed in patients suffering from

a severe form of tinnitus (Langguth, Kreuzer et al. 2013). Hence, diagnosis and treatment

require a great deal of expertise to detect existing etiology and comorbidity. For the

treatment of complex tinnitus cases, therefore, a multidisciplinary approach is

recommended (Shi, Robb et al. 2014, Van de Heyning, Gilles et al. 2015).

To date, there is no drug or psychotherapeutic treatment that can fully alleviate chronic

subjective tinnitus. Patients suffering from chronic tinnitus often keep on seeking a cure or

some form of relief for their persistent symptoms. Current recommended forms of therapy

consist of psychotherapeutic interventions that are intended to train the patient, through

sound enrichment and psychoeducation or through learning helpful thoughts, to learn to

147260 Luyten BNW.indd 11 22-12-2020 13:54 react differently to the tinnitus sound. Pharmacological treatments are mainly used to

reduce the secondary effects of tinnitus symptoms, such as sleep difficulties, anxiety

symptoms, depressive feelings and concentration problems.

Studies have shown that Tinnitus Retraining Therapy (TRT) can significantly improve the

quality of life for tinnitus patients. Furthermore, there is evidence for the effectiveness of

cognitive behavioral therapy (CBT) that can effectively alleviate symptoms by changing

dysfunctional cognitions. For a part of the patients with tinnitus symptoms, these forms of

treatment lead to a reduction in their carrying burden. However, when tinnitus causes a

major interference with daily functioning, these treatment methods are not sufficiently

effective enough for all patients (Cima, Maes et al. 2012).

Recent evidence shows that Eye Movement Desensitization and Reprocessing (EMDR)

can be an effective therapy for symptoms such as chronic pain and phantom pain (Van

Rood and De Roos 2009). Starting from tinnitus as phantom percept, it is possible that

EMDR may be an alternative and effective treatment method for patients with tinnitus

(Rikkert, Van Rood et al. 2018, Phillips, Erskine et al. 2019).

This dissertation focuses on the current psychotherapeutic landscape in the treatment of

chronic subjective tinnitus aiming to investigate an alternative treatment method. Therefore,

the following research objectives were formulated:

147260 Luyten BNW.indd 12 22-12-2020 13:54 o Describing EMDR as a treatment method and investigating the efficacy

of EMDR in the treatment of tinnitus.

o Analyzing the effect of EMDR in comparison to CBT in the treatment of

chronic subjective tinnitus.

o Assessing whether bimodal therapy for chronic subjective tinnitus

consisting of the combination of TRT and EMDR results in a clinically

significant different efficacy compared to the current recommended

bimodal TRT and CBT therapy.

o Exploring the influence of specific personality traits as a result of the

therapeutic intervention of TRT/EMDR and TRT/CBT.

PART I THE VALUE OF EMDR IN THE TREATMENT OF TINNITUS

The first part of this doctoral thesis examines whether there is evidence for the

effectiveness of EMDR in the treatment of chronic subjective tinnitus. The systematic

review describes the evaluation of two eligible studies based on the Platinum Standards.

The review shows that more than 50% of patients experience clinically significant

improvement after EMDR treatment. The established improvement remains stable until at

least three months after therapy. The pilot studies demonstrate that EMDR creates

opportunities in decreasing tinnitus distress. This is the first systematic review to provide

an overview of existing studies of EMDR in the treatment of tinnitus.

147260 Luyten BNW.indd 13 22-12-2020 13:54 PART II RANDOMIZED CONTROLLED STUDY OF EMDR FOR TINNITUS

The second part of this dissertation proposes the study protocol of a randomized

controlled trial with blind evaluator, examining the effects of two bimodal tinnitus therapies,

more specifically TRT + CBT and TRT + EMDR. Analyses of results from the Tinnitus

Functional Index (TFI), Tinnitus Questionnaire (TQ), Visual Analogue Scale for Tinnitus

Loudness (VASLoudness), Hyperacusis Questionnaire (HQ) and Hospital Anxiety and

Depression Scale (HADS) show that both bimodal therapies lead to clinically significant

improvements shortly after treatment. Measurements three months after therapy show an

even greater reduction in tinnitus symptoms.

Clinically significant improvement is found in terms of tinnitus intrusiveness, sense of

control, cognitive interference, sleep disturbance, relaxation, quality of life and emotional

distress. No significant difference between the bimodal therapies was found three months

after treatment. After follow-up, 81% of the patients in the TRT/EMDR therapy group report

feeling better to a lot better and 84% in the TRT/CBT therapy group state experiencing

improvement to a great deal of improvement. This randomized, controlled trial makes a

contribution to the reduction of chronic tinnitus symptoms by providing two treatment

protocols that lead to clinically significant improvement.

PART III INFLUENCING FACTORS IN THE TREATMENT OF TINNITUS

An exploratory study is described in the third part of the doctoral thesis. Data from 82

patients treated by the bimodal therapy TRT/EMDR or TRT/CBT, are used to investigate

correlations with the Big Five Inventory-II (BFI-II) in the context of the influence of personality

147260 Luyten BNW.indd 14 22-12-2020 13:54 traits in the psychological treatment of tinnitus. The implementation of a K-means cluster

analysis leads to four specific BFI – personality profiles that respond to psychological

treatment in a clinically relevant and different way. This exploratory study shows that

patients who score high on the personality trait Negative Emotionality and low on the

personality traits Extraversion, Agreeableness, Conscientiousness, and Open-

Mindedness experience less therapeutic gain from 10 sessions of specialized tinnitus

therapy compared to individuals who only score low for the trait Conscientiousness and

higher for the other traits. The analyses indicate an important influence of the personality

trait Conscientiousness that creates a specific personality profile in the four clusters with

significantly different therapy outcomes.

Future tinnitus treatments may benefit from additional research on the influence of

personality traits to gain more insights in which therapy works for whom and which

treatment modalities may be important within a therapeutic process.

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147260 Luyten BNW.indd 16 22-12-2020 13:54 Samenvatting

Tinnitus wordt gedefinieerd als de waarneming van geluid zonder de aanwezigheid van

een externe auditieve input m.a.w. een fantoompercept (De Ridder, Elgoyhen et al. 2011).

Meestal is deze tinnitus van voorbijgaande aard. Bij 8 - 20% van de bevolking wordt echter

de diagnose van chronische tinnitus gesteld wanneer de klachten langer dan drie

maanden aanwezig zijn. Van deze populatie ondervindt ongeveer 1 - 3% zoveel hinder

waardoor zij medische hulp zoeken (Baguley, McFerran et al. 2013).

De patiënten geven aan piepende, zoemende of sissende geluiden waar te nemen, wat

tot een zekere psychologische draaglast kan leiden en een serieuze impact op de

levenskwaliteit kan hebben. Er wordt een hoge comorbiditeit van o.a. slapeloosheid,

depressie, en angst vastgesteld bij patiënten die lijden aan een ernstige vorm van tinnitus

(Langguth, Kreuzer et al. 2013). Vandaar dat de diagnosestelling en behandeling een grote

deskundigheid vereisen om de bestaande etiologie en comorbiditeit op te sporen. Voor

de behandeling van complexe tinnituscasussen is daarom ook een multidisciplinaire

aanpak door NKO-artsen, gespecialiseerde audiologen en psychologen aangewezen

(Shi, Robb et al. 2014, Van de Heyning, Gilles et al. 2015).

Tot op heden zijn de beschikbare medicamenteuze en psychotherapeutische

behandelingen voor chronische subjectieve tinnitus niet voor iedereen voldoende

toereikend. Patiënten die lijden aan chronische tinnitus blijven vaak om die reden op zoek

147260 Luyten BNW.indd 17 22-12-2020 13:54 naar een remedie of enige vorm van verlichting voor hun aanhoudende klachten. Huidige

aanbevolen therapievormen bestaan uit psychotherapeutische interventies die bedoeld

zijn om de patiënt te trainen om anders te leren reageren op het tinnitusgeluid, via

geluidsverrijking en psycho-educatie ofwel via het aanleren van helpende gedachten.

Medicamenteuze behandelingen worden voornamelijk gebruikt om de secundaire effecten

van de tinnitusklachten te verminderen, zoals o.a. slaapmoeilijkheden, angstklachten,

depressieve gevoelens en concentratieproblemen.

Studies hebben aangetoond dat Tinnitus Retraining Therapie (TRT) de levenskwaliteit voor

tinnituspatiënten aanzienlijk kan verbeteren. Verder bestaat er evidentie voor de effectiviteit

van cognitieve gedragstherapie (CBT) dat klachten duidelijk kan verlichten door het

veranderen van disfunctionele cognities. Voor een deel van de patiënten met

tinnitusklachten leiden deze behandelingsvormen voor een vermindering van hun

draaglast. Wanneer de tinnitus echter zorgt voor een grote interferentie met het dagelijks

functioneren, zijn deze behandelmethoden niet doeltreffend genoeg voor alle patiënten

(Cima, Maes et al. 2012).

Uit recente inzichten blijkt dat Eye Movement Desensitization and Reprocessing (EMDR)

een effectieve therapie kan zijn voor symptomen zoals chronische pijn en fantoompijn (Van

Rood and De Roos 2009). Vertrekkende van tinnitus als fantoom percept, is het mogelijk

dat EMDR een alternatieve en werkzame behandelmethode kan zijn voor patiënten met

tinnitus (Rikkert, Van Rood et al. 2018, Phillips, Erskine et al. 2019).

147260 Luyten BNW.indd 18 22-12-2020 13:54 Dit proefschrift richt zich op de stand van zaken binnen het psychotherapeutisch

landschap in de behandeling van chronische subjectieve tinnitus met het oog op het

onderzoeken van een alternatieve behandelmethode. Daarom werden de volgende

onderzoeksdoelstellingen geformuleerd:

o Het beschrijven van EMDR als behandelmethode en het onderzoeken

van de werkzaamheid van EMDR in de behandeling van tinnitus.

o Het analyseren van het effect van EMDR in vergelijking met CBT in de

behandeling van chronische subjectieve tinnitus.

o Beoordelen of een bimodale therapie voor chronische subjectieve

tinnitus bestaande uit de combinatie van TRT en EMDR resulteert in

een klinisch significante verschillende werkzaamheid in vergelijking met

de huidige aanbevolen bimodale TRT- en CBT-therapie.

o Het exploreren van de invloed van specifieke

persoonlijkheidskenmerken als gevolg van de therapeutische

interventie van TRT/EMDR en TRT/CBT.

DEEL I DE WAARDE VAN EMDR IN DE BEHANDELING VAN TINNITUS

In deel 1 van deze doctoraatsthesis wordt onderzocht of er evidentie bestaat voor de

effectiviteit van EMDR in de behandeling van chronische subjectieve tinnitus. De

systematische review beschrijft de evaluatie van twee geïncludeerde studies aan de hand

van de Platinum Standards. De review toont aan dat meer dan 50% van de patiënten een

klinisch significante verbetering ervaart na de EMDR-behandeling. De aangetoonde

147260 Luyten BNW.indd 19 22-12-2020 13:54 verbetering blijft stabiel tot minstens drie maanden na de therapie. De pilootstudies

demonstreren dat EMDR opportuniteiten schept voor het verminderen van tinnitus stress.

Dit is de eerste systematische review die een overzicht geeft van bestaande onderzoeken

naar EMDR in de behandeling van tinnitus.

DEEL II GERANDOMIZEERDE GECONTROLEERDE STUDIE VAN EMDR VOOR TINNITUS

In deel twee wordt het studieprotocol van een gerandomizeerde gecontroleerde trial met

blinde evaluator voorgesteld waarbij de effecten van twee bimodale tinnitustherapieën met

name TRT + CBT en TRT + EMDR, onderzocht worden. Analyses van resultaten van de

Tinnitus Functioneringsindex (TFI), Tinnitus Vragenlijst (TQ), Visueel Analoge Schaal voor

tinnitus luidheid (VASLuidheid), Hyperacusis Vragenlijst (HQ) en Hospital Anxiety and

Depression Scale (HADS) tonen aan dat beide bimodale therapieën vlak na de

behandeling een klinisch significante verbetering teweegbrengen. Bij metingen drie

maanden na de therapie blijkt dat er een nog grotere vermindering van tinnitusklachten

optreedt.

Klinisch significante verbetering wordt gevonden op vlak van intrusiviteit van de tinnitus,

gevoel van controle, cognitieve klachten, slaapmoeilijkheden, relaxatie, levenskwaliteit en

emotionele stress. Er werd geen significant verschil tussen de bimodale therapiën

gevonden drie maanden na de behandeling. In de bimodale therapie TRT/EMDR

geven 81% van de patiënten aan zich beter tot heel veel beter te voelen na de

behandeling en in de TRT/CBT therapie rapporteert 84% verbetering tot heel veel

verbetering door de vermindering van tinnitusklachten. Deze gerandomiseerde,

gecontroleerde studie levert een bijdrage aan de vermindering van chronische

147260 Luyten BNW.indd 20 22-12-2020 13:54 tinnitusklachten door het aanreiken van twee behandelprotocollen die leiden tot

klinisch significante verbetering.

DEEL III BEÏNVLOEDENDE FACTOREN IN DE BEHANDELING VAN TINNITUS

In dit deel van het doctoraal proefschrift wordt een exploratieve studie beschreven. Er

wordt gebruik gemaakt van de data van 82 patiënten, behandeld door de bimodale

therapie TRT/EMDR of TRT/CBT, om correlaties met de Big Five Inventory-II (BFI-II) te

onderzoeken in het kader van de invloed van persoonlijkheidskenmerken in de

psychologische behandeling van tinnitus. De implementatie van een K-means

clusteranalyse leidt tot vier specifieke BFI – persoonlijkheidsprofielen die op een klinisch

relevante en verschillende manier reageren op een psychologische behandeling. Deze

verkennende studie toont aan dat patiënten die hoog scoren op de persoonlijkheidstrek

Negatieve Emotionaliteit en laag op de persoonlijkheidstrekken Extraversie, Altruïsme,

Consciëntieusheid, en Openheid minder therapeutische winst halen uit 10 sessies

gespecialiseerde tinnitus therapie in vergelijking met personen die enkel laag scoren voor

de trek Consciëntieusheid en hoger voor de andere trekken. De analyses indiceren een

belangrijke invloed van de persoonlijkheidstrek Consciëntieusheid dat in de vier clusters

zorgt voor een specifiek persoonlijkheidsprofiel met significant verschillende therapie-

uitkomsten.

Toekomstige tinnitusbehandelingen kunnen baat hebben bij verder onderzoek naar de

invloed van persoonlijkheidstrekken om meer zicht te krijgen op welke therapie voor wie

werkt en welke behandelmodaliteiten belangrijk kunnen zijn binnen een therapeutisch

proces.

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C ontents

General Introduction 37 1

Eye Movement Desensitization Reprocessing 65 2 in the treatment of chronic subjective tinnitus: A Systematic Review

The value of Eye Movement Desensitization 95 3 Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial

Bimodal therapy for chronic subjective tinnitus: 121 4 a randomized controlled trial of EMDR and TRT versus CBT and TRT

The influence of personality traits in the 159 5 psychotherapeutic treatment of chronic tinnitus

General Discussion & Conclusions 185 6

197 7 Future Perspectives

APPENDICES 211 BIBLIOGRAPHY 2 2 1 CURRICULUM VITAE 2 47 PUBLICATIONS 2 49 ATTENDED CONFERENCES 2 51 PRESENTATIONS 2 53 COURSES & TRAINING 2 55 DANKWOORD 2 57

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List of Figures

Figure 1.1 Brain networks involved in tinnitus (i.e. phantom) perception. Figure 1.2 Diagram representing the sinusoidal fluctuation of brain activity and the awareness threshold in relation to tinnitus suffering. Figure 1.3 The Neurophysiological Model of Jastreboff. Figure 1.4 A cognitive model of tinnitus distress. Figure 1.5 Illustration of a vicious cycle for tinnitus-induced distress based on the CBT-principles. Figure 1.6 Illustration of the eight phases of EMDR. Figure 2.1 Preferred reporting items for systematic reviews and meta-analyses flow diagram of study inclusion (Moher, Shamseer et al. 2015). Figure 3.1 Consolidated Standards of Reporting Trials (CONSORT) study flow diagram. TRT Tinnitus Retraining Therapy, CBT Cognitive Behavioral Therapy, EMDR Eye Movement Desensitization Reprocessing. Figure 3.2 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline schedule of enrollment, interventions and assessments for both intervention groups. Figure 4.1 Study design. Figure 4.2 Consort Flow Diagram. Trial profile of the 166 patients who were screened for eligibility. A total of 89 patients completed the study. Figure 4.3 Total TFI scores by therapy group and time period. Error bars representing 95% CI interval. Figure 4.4 Overview of mean decrease at follow up on all TFI subscales. Figure 4.5 Total TQ scores by therapy group and time period. Error bars representing 95% CI interval. Figure 4.6 A. Mean of Total Fear scores by therapy group and time period. B. Mean of Total Depression scores by therapy group and time period. C. Mean of Total HQ scores by therapy group and time period. D. Mean of Total VAS scores

147260 Luyten BNW.indd 25 22-12-2020 13:54 of tinnitus loudness by therapy group and time period. Error bars representing 95% CI interval. Figure 5.1 Correlations between personality traits and tinnitus severity. 1A: Correlations between BFI trait scores and TFI scores at baseline. 1B: Correlations between BFI trait scores and ΔTFI scores (i.e. differences in TFI at follow-up and TFI at baseline). Figure 5.2 Results of the k-means clustering analysis. BFI scores are presented as normalized Z-scores. Individual BFI scores are represented by thin lines; mean scores for each cluster are represented by a thick line. Figure 5.3 Effect of cluster membership on TFI scores. 3A: No significant differences in TFI scores at baseline were found between clusters. 3B: Members of cluster 1 achieved significantly higher ΔTFI scores than members of cluster 2 and 4. *: p < 0.05, **: p < 0.01.

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List of Tables

Table 1 Platinum Standard assessment tool with the rating scale providing three answer options to score the items (0, 0.5 and 1) according to Hertlein, K. M., & Ricci, R. J. (2004).

Table 2 Characteristics of the included studies.

Table 3 Outcome measurements.

Table 4 Intervention based on the cognitive behavioral therapy (CBT) treatment outline.

Table 5 Summary of the intervention based on the standard treatment Eye Movement Desensitization Reprocessing (EMDR) protocol by Shapiro (2001).

Table 6 Baseline characteristics.

Table 7 Primary and secondary outcome measures at baseline, after treatment and 3 months after treatment.

Table 8 Group differences for primary and secondary outcomes.

Table 9 Baseline demographic characteristics of all participants.

Table 10 Personality Scores.

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List of Appendices

A List of potentially relevant studies

B Summary of treatment protocol TRT/CBT

C Summary of treatment protocol TRT/EMDR

D BFI-2 items summarized from Soto and John (2017)

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Abbreviations

A Agreeableness ACT Acceptance and Commitment Therapy AIP Adaptive Information Processing ANOVA Analysis of Variance ANS Automatic Nervous System BAI Beck Anxiety Index BDI Beck Depression Inventory BFI Big Five Inventory CBT Cognitive Behavioral Therapy CBT4T Cognitive Behavioral Therapy for tinnitus C Conscientiousness CONSORT Consolidated Standards of Reporting Trials CSI Clinically Significant Improvement CT Cognitive Therapy dACC dorsal Anterior Cingulate Cortex dBHL Decibel Hearing Level DBT Dialectical Behavior Therapy dBSL Decibel Sensation Level dLPFC dorsolateral prefrontal cortex DMN Default Mode Network DPOAEs Distortion Product Otoacoustic Emissions E Extraversion EEG electroencephalography EMDR Eye Movement Desensitization Reprocessing ENT Ear Nose Throat ERP Event-Related Potential HADS Hospital Anxiety and Depression Scale HD-tDCS high-definition transcranial direct current stimulation HQ Hyperacusis Questionnaire GPE Global Perceived Effect GRADE Grading of Recommendations, Assessment, Development and Evaluations iCBT Internet-based CBT ISO International Organization for Standardization kHz KiloHertz LIST Leuven Intelligibility Sentence Test

147260 Luyten BNW.indd 31 22-12-2020 13:54 MBCT Mindfulness – Based Cognitive Therapy MEG Magnetoencephalography Mini-TQ Mini – Tinnitus Questionnaire MML Minimal Masking Level NC Negative Cognition N Negative Emotionality NNT Number Needed to Treat O Open-Mindedness PC Positive Cognition PCC Posterior Cingulate Cortex PD Panic Disorder PICOS Participants Intervention Comparator Outcome Study design PRISMA Preferred Reporting Items for Systematic Reviews and Meta- Analyses PTSD post-traumatic stress disorder PTA Pure Tone Average RCT Randomized Controlled Trial REBT Rational Emotive Behavior Therapy rTMS repetitive transcranial magnetic stimulation SCL-90 Symptom Checklist – 90 SD Standard Deviation sgACC subgenual Anterior Cingulate Cortex SNR Signal to Noise Ratio SPIRIT Standard Protocol Items Recommendations for Interventional Trials SPIN Speech-in-noise SPL Sound Pressure Level SRIP Self – Rating Inventory List for Post – traumatic Stress Disorder SRT Speech reception threshold SUDS Subjective Units of Disturbance Scale tDCS transcranial direct current stimulation tEMDR tailored EMDR protocol for tinnitus TFI Tinnitus Functional Index TINTRA Tinnitus Treatment and Research center Antwerp THI Tinnitus Handicap Inventory TMD Temporomandibular disorder TQ Tinnitus Questionnaire TRT Tinnitus Retraining Therapy VAS Visual Analogue Scale VoC Validity of Cognition scale

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GENERAL INTRODUCTION

CHAPTER ONE

1 GENERAL INTRODUCTION

Chapter

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147260 Luyten BNW.indd 36 22-12-2020 13:54 GENERAL INTRODUCTION

1. GENERAL INTRODUCTION

1.1 TINNITUS: DEFINITION, PREVALENCE, AETIOLOGY AND COMORBIDITIES

Tinnitus is defined as a symptom characterized by the conscious perception of auditory

sensations, without an external sound source. It is known as “ringing in the ears”, but can

also be perceived as more noise-like e.g. whistling, sizzling, buzzing, or chirping (Baguley,

McFerran et al. 2013).

A differentiation is made between objective and subjective tinnitus (Møller 2003). Objective

tinnitus is the perception of a sound resolving from a physical source in or near the ear or

head (e.g. blood flow or muscle contractions). The occurrence of subjective tinnitus is

typified by the absence of sound that can be perceived by another person or assessor,

also known as phantom percept (Jastreboff 1990, De Ridder, Elgoyhen et al. 2011). This

phantom sensation appears to emerge from deafferentation of central auditory brain areas

caused by disruption along the auditory pathway accompanied by neural alterations

(Eggermont 2012, Gilles, Schlee et al. 2016, Mohan and Vanneste 2017). Tinnitus may

be pulsatile, non-pulsatile, unilateral, bilateral or central, intermittent or constant. When

tinnitus sounds are present for more than three months, the diagnosis of chronic tinnitus

is determined (Hall, Láinez et al. 2011) and after six months the likelihood of spontaneous

remission is low (Rief, Weise et al. 2005). In this doctoral thesis the main focus is on

chronic subjective tinnitus, which will therefore simply be referred to as ‘tinnitus’.

147260 Luyten BNW.indd 37 22-12-2020 13:54 GENERAL INTRODUCTION

The prevalence of tinnitus has been estimated in the range of 10% - 15% in the adult

population. For about 2,4% of this population, tinnitus is perceived as a significant and

severe problem (Axelsson and Ringdahl 1989) negatively influencing the quality of life.

Prevalence studies show that in about 0.5% - 1.6% of these cases, the sound is so

debilitating that professional help is required (Baguley, McFerran et al. 2013).

Comorbidities and associated syndromes may aggravate the tinnitus experience.

Psychiatric disorders such as anxiety, depression, and sleep disabilities tend to be more

prevalent in tinnitus patients. Several studies report 26.7% - 77% of tinnitus sufferers to

have at least one psychiatric diagnosis (Marciano, Carrabba et al. 2003, Belli, Belli et al.

2008). Moreover, a lifetime prevalence of comorbid anxiety of 45% has been detected

(Pattyn, Van Den Eede et al. 2016).

In 50.5% of the cases tinnitus is associated with otological diseases (e.g. hearing loss,

noise trauma, otosclerosis, Meniere’s disease, acoustic neuroma, and ototoxic

substances) (Gilles, Goelen et al. 2014). The occurrence of tinnitus and decreased sound

tolerance (i.e. hyperacusis) is also known to be high since 40% of tinnitus patients also

report hyperacusis (Anari, Axelsson et al. 1999). Specific conditions can be influential as

well such as neurological (e.g. migraine, epilepsy, multiple sclerosis, or meningitis),

endocrine and metabolic (e.g. diabetes mellitus, or hormonal changes), orofacial (e.g.

temporomandibular joint disorder) or traumatic (e.g. head or neck injury) diseases

(Baguley, McFerran et al. 2013). The presence of the large variability of symptoms and

comorbidities creates challenges to understand the underlying pathophysiologic

mechanisms of tinnitus and to treat the symptom of tinnitus.

147260 Luyten BNW.indd 38 22-12-2020 13:54 GENERAL INTRODUCTION

A wide range of explanatory models have been proposed (Sedley, Friston et al. 2016). To

date, no specific model covers the aetiologic mechanism of the whole tinnitus framework,

although widespread evidence on the physiological basis of tinnitus has shown that

changes in the auditory pathways resulting from disruption in the central nervous system

can elicit tinnitus. These neural alternations cause reorganization and hyperactivity at the

level of the auditory cortex (Salvi, Wang et al. 2000, De Ridder, Elgoyhen et al. 2011,

Baguley, McFerran et al. 2013). Llinás et al. (1999) concluded that tinnitus perception is

caused by thalamocortical dysrhythmias triggered by peripheral damage. A decreased

functional connectivity between the thalamus and auditory cortical areas in tinnitus

(Rauschecker, Leaver et al. 2010, Zhang, Chen et al. 2015, Chen, Wang et al. 2017)

results in a disrupted thalamic gating mechanism (Rauschecker, Leaver et al. 2010).

Hence, when this mechanism, responsible for the sensory-auditory pathways and thus,

the ascending noise canceling system, is dysfunctional, tinnitus may be perceived instead

of blocked (Rauschecker, Leaver et al. 2010).

Subsequently, modifications in neural activity affect non-auditory brain areas. The stress

and emotional reactions associated with tinnitus presumably find their neuronal correlation

in the amygdala, anterior cingulate cortex, dorsolateral prefrontal cortex, parahippocampus

and insula. Since neuronal changes also appear in these regions, tinnitus can be

described as a phenomenon in which networks of auditory and non-auditory brain areas

influence each other and which results from maladaptive plastic changes covering an

extensive network of cortical regions (e.g. central auditory system) and subcortical

constructs (e.g. limbic system). The involvement of these brain networks (i.e. the

147260 Luyten BNW.indd 39 22-12-2020 13:54 GENERAL INTRODUCTION

perception, salience, distress, and memory network; somatosensory and auditory cortex)

are shown in Figure 1.1 (De Ridder, Elgoyhen et al. 2011).

FIGURE 1.1: FIGURE RETRIEVED FROM DE RIDDER ET AL. (2011). BRAIN NETWORKS

INVOLVED IN TINNITUS (I.E. PHANTOM) PERCEPTION. (SGACC, SUBGENUAL

ANTERIOR CINGULATE CORTEX; DACC, DORSAL ANTERIOR CINGULATE CORTEX;

PCC, POSTERIOR CINGULATE CORTEX)

Treatment should therefore focus on targeting the different modalities of tinnitus, taking

into account that tinnitus does not represent a disease, but a symptom of numerous

possible underlying disorders (Han, Lee et al. 2009). Bothersome tinnitus could be

described as a psychological disorder, considering maladaptive psychological responses

147260 Luyten BNW.indd 40 22-12-2020 13:54 GENERAL INTRODUCTION

can aggravate or interrupt the quality of life and daily functioning of persons suffering from

it (Cima 2018). Dependent of the representation of comorbid malfunctions and individual

dependent tinnitus perception, specific therapy options might be indicated. For this

reason, there is no one-treatment-fits-all standard in current tinnitus management.

Multidisciplinary assessment is required to determine the degree of tinnitus suffering in

order to refer to the adequate therapeutic support. Figure 1.2a shows the normal threshold

and normal brain activity of persons who do not perceive tinnitus as debilitating. The next

figure (1.2b) illustrates how focusing on the tinnitus accompanied by annoyance and

distress, decreases the awareness threshold. When an increased brain activity (figure

1.2c), elicited by generalized central nervous system disorders (e.g. depression, anxiety

and / or sleeping disorders, and burnout), is accompanied by a normal threshold, patients

are more vulnerable to suffer from tinnitus (Van de Heyning, Gilles et al. 2015).

FIGURE 1.2: DIAGRAM REPRESENTING THE SINUSOIDAL FLUCTUATION OF BRAIN ACTIVITY AND THE AWARENESS THRESHOLD IN RELATION TO TINNITUS SUFFERING. FIGURE RETRIEVED FROM VAN DE HEYNING ET AL. (2015).

147260 Luyten BNW.indd 41 22-12-2020 13:54 GENERAL INTRODUCTION

This proposed diagram provides a framework to identify which therapeutic actions will be

needed to effectively alleviate tinnitus impairment and enhance the quality of life. Not every

tinnitus patient will need the same treatment trajectory. Therefore, thorough tinnitus

assessment is necessary to examine the tinnitus characteristics and perhaps more

importantly, the individual characteristics such as e.g. awareness threshold and resilience,

personality traits, and contextual factors.

1.2 PSYCHOLOGICAL THERAPIES IN THE TREATMENT OF TINNITUS

Most reported psychological-based therapies are tinnitus education and Cognitive

Behavioral Therapy (CBT) (Thompson, Hall et al. 2017). Specialized multidisciplinary

treatment has been proposed to meet the needs of patients suffering from tinnitus (Cima,

Maes et al. 2012, Van de Heyning, Gilles et al. 2015, Nolan, Gupta et al. 2020). The

combination of Tinnitus Retraining Therapy (TRT) and CBT has also been proven to be

cost-effective (Van de Heyning, Gilles et al. 2015), whereas the implementation of a

stepped-care approach, consisting of psychoeducation as first step and specialized CBT

for tinnitus as second step, has demonstrated significant improvement for tinnitus-related

stress as well (Cima, Andersson et al. 2014). European Guidelines have outlined this

stepped-care specialized CBT-based treatment as recommended treatment method

(Cima, Mazurek et al. 2019).

Recently a number of researchers have concentrated on using Eye Movement

Desensitization and Reprocessing (EMDR) to treat tinnitus. These pilot studies indicated a

significant decrease of tinnitus distress after EMDR (Rikkert, Van Rood et al. 2018, Phillips,

147260 Luyten BNW.indd 42 22-12-2020 13:54 GENERAL INTRODUCTION

Erskine et al. 2019). This protocollary therapeutic intervention might be an effective

treatment method for patients suffering from this phantom percept as EMDR effectively

alleviates chronic and phantom limb pain. To date, there is no curative treatment for tinnitus

and thus, further research is warranted. The focus of the current dissertation is on

psychotherapeutic treatments, which will therefore be implied by the term ‘therapy’ in the

further thesis.

1.2.1 TINNITUS RETRAINING THERAPY

Tinnitus Retraining Therapy (TRT) is a clinical therapeutic intervention, based on the

neurophysiological model of tinnitus, developed by Prof. Pawel Jastrebroff and Dr.

Jonathan Hazell (Jastreboff 1990, Jastreboff and Hazell 1993, Jastreboff and Hazell

2008). TRT is considered to be a psychological and behavioral treatment method (Pichora-

Fuller, Santaguida et al. 2013, Tunkel, Bauer et al. 2014). The main targets of TRT are

habituation to the reactions evoked by tinnitus and habituation to tinnitus perception in the

subsequent stage. During directive counseling the patient learns to reclassify the tinnitus

signal to the category of neutral stimuli. Sound enrichment is used to decrease the strength

of the tinnitus signal by increasing the level of background neuronal activity in the auditory

system (Jastreboff 2011).

The model explains the involvement of the limbic system and autonomic nervous system

(ANS), as depicted in Figure 1.3, to be crucial in the development and continuation of the

associated stress, whereas the auditory system plays a secondary role in the perception

of tinnitus. When a person perceives tinnitus without a negative reaction, the signal may

147260 Luyten BNW.indd 43 22-12-2020 13:54 GENERAL INTRODUCTION

be constrained within the auditory pathways. However, if the tinnitus sound evokes

negative reactions such as annoyance, anxiety, and panic, activity in the limbic system

(i.e. amygdala, cingulate cortex, hippocampus, hypothalamus, and thalamus) and the ANS

arises. These emotional and conditioned reflexes activate the auditory and other cortical

areas where conscious perception and evaluation sets in.

TRT consists of specific interventions e.g. explanation of the anatomy and physiology of

the normal and impaired auditory system, the role of the central auditory system and higher

cortical processes, sensory contrast, selective perception of sensory information,

clarification of the neurophysiological model of tinnitus by Jastreboff, counseling about

sound enrichment and sound generators and providing information about stress reduction,

relaxation exercises, sleep hygiene, concentration, and hearing tips.

FIGURE 1.3: THE NEUROPHYSIOLOGICAL MODEL OF JASTREBOFF. FIGURE

RETRIEVED FROM JASTREBOFF (2011).

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TRT results in significant improvement for about 80% of the patients (Herraiz, Hernandez

et al. 2005, Jastreboff 2015). Research on the effectivity of TRT is abundant, although

only one randomized controlled trial was found that reported the exact TRT protocol as

developed by Jastreboff and Hazell (Phillips and McFerran 2010). Clinical research applies

a wide range of modified forms of TRT (Mazurek, Fischer et al. 2006, Aazh, Moore et al.

2008, Phillips and McFerran 2010, Seydel, Haupt et al. 2010, Seydel, Haupt et al. 2015,

Kim, Jang et al. 2016) showing positive effects. A systematic review on the comparison

between TRT and CBT concluded that both therapies are effective for tinnitus, improving

the negative impact and improving the quality of life (Grewal, Spielmann et al. 2014).

1.2.2 COGNITIVE BEHAVIORAL THERAPY

Cognitive Behavioral Therapy (CBT) is an integrative treatment based on the three key

propositions i.e. that cognitive activity affects behavior, that cognitive activity can be

monitored and modified, and that desired behavior change can be affected through

cognitive alternation (Dobson and Dozois 2010). CBT was founded in the 1960s by Aaron

Beck and Albert Ellis (Lebow 2012). This psychotherapeutic treatment was originally based

on the theoretical structures of the Cognitive Therapy (Hoare, Kowalkowski et al.) outlined

by Beck and the Rational Emotive Behavior Therapy (REBT) of Ellis. Undergoing specific

evolutions, several ‘waves’ appeared within the cognitive and behavioral psychotherapy

approaches. The ‘first wave’ focused on behavioral principles affecting clinical targets (i.e.

respondent and operant conditioning learning principles), whereas the ‘second wave’ was

typified by cognitive principles and social learning aiming at cognitive, emotional and

behavioral targets (Dobson and Dozois 2010, Hayes 2016). The ‘third wave’ covers the

147260 Luyten BNW.indd 45 22-12-2020 13:54 GENERAL INTRODUCTION

treatments with a link to acceptance, mindfulness, cognitive defusion, dialectics, values,

spirituality, and relationship e.g. Acceptance and Commitment Therapy (ACT) (Hayes,

Strosahl et al. 1999), Mindfulness – Based Cognitive Therapy (MBCT) (Teasdale, Moore

et al. 2002), and Dialectical Behavior Therapy (DBT) (Linehan 1993). Still, the core idea is

the assumption that cognitive processes influence behavior and that behavioral change

can alter cognitions. During cognitive restructuring, three levels of cognition are defined

i.e. conscious thoughts, automatic thoughts and schemas (‘core beliefs’). The tinnitus-

related distress is largely dependent on the evaluation and significance of the tinnitus given

by the patient. The thoughts associated with tinnitus determine which emotional reactions

are provoked. CBT helps the patient to change specific evoked thoughts and thus to

reverse the emotional response.

During treatment structured methods, psychoeducation and occasionally homework

assignments are integrated to tackle the dysfunctional core beliefs in a problem-oriented

manner. An integration of behavioral interventions (e.g. activity scheduling, graded task

assignments, exposure and response prevention, and relaxation training) and cognitive

techniques (e.g. Socratic Questioning, guided discovery, examining evidence, identifying

cognitive errors, generating rational alternatives, and imagery) can be applied within the

therapeutic process (Wright 2006).

A specific tinnitus model based on the cognitive- behavioral principles was developed by

McKenna, Handscomb, Hoare, & Hall (2014). Figure 1.4 depicts the processes involved

in the development and continuance of tinnitus distress. When the tinnitus sound is

147260 Luyten BNW.indd 46 22-12-2020 13:54 GENERAL INTRODUCTION

accompanied with excessively negative (automatic) thoughts, distress is elicited. These

thoughts provoke arousal and emotional distress. Maintaining factors, e.g. selective

attention, monitoring, and counterproductive safety behaviors, arise as a consequence of

these negative thoughts. These processes result in a distorted perception of tinnitus

through overestimating the intensity and complexity of tinnitus. Selective attention and

monitoring lead to better detection of the tinnitus and to further negative appraisal.

This distorted perception and negative appraisal influence one another as distorted

perception results in additional negative appraisal, which cultivates the distorted

perception of tinnitus. Counterproductive coping behaviors e.g. worrying, detecting the

tinnitus, manipulation of environmental sounds, and isolation, maintain or aggravate the

existing perceived threat. Negative thoughts are fostered by (‘core’-) beliefs or schema’s

about experiences of tinnitus in others, health, the self, or the world (McKenna,

Handscomb et al. 2014).

147260 Luyten BNW.indd 47 22-12-2020 13:54 GENERAL INTRODUCTION

FIGURE 1.4: A COGNITIVE MODEL OF TINNITUS DISTRESS. FIGURE RETRIEVED

FROM MCKENNA ET AL. (2014).

The following model (Aazh, Landgrebe et al. 2019) illustrates another CBT-based vicious

cycle responsible for the maintenance of the tinnitus complaints (Figure 1.5). This model

represents a more practical application for clinicians.

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FIGURE 1.5: ILLUSTRATION OF A VICIOUS CYCLE FOR TINNITUS-INDUCED

DISTRESS BASED ON THE CBT-PRINCIPLES. FIGURE RETRIEVED AND ADAPTED

FROM DR. AAZH (2019).

The efficacy of CBT as treatment for tinnitus is well-established. Numerous meta-analyses

have been conducted over the years (Martinez!Devesa, Perera et al. 2010, Hesser, Weise

et al. 2011, Hoare, Kowalkowski et al. 2011, Grewal, Spielmann et al. 2014, Zenner, Delb

et al. 2017), offering evidence from RCTs concluding CBT to be an alleviating treatment

method for tinnitus distress. A recent systematic review (Fuller, Cima et al. 2020) revealed

that CBT probably reduces the negative impact of tinnitus on one’s quality of life.

Furthermore, Fuller et al. (2020) provided evidence for the implication of two clinical

guidelines recommending CBT for patients with chronic bothersome tinnitus (Tunkel,

147260 Luyten BNW.indd 49 22-12-2020 13:54 GENERAL INTRODUCTION

Bauer et al. 2014, Cima, Mazurek et al. 2019). However, conclusions drawn from the

latest published systematic review, show evidence (i.e. GRADE – levels) (Andrews, Guyatt

et al. 2013) ranging from moderate to very low. Future research is warranted to conduct

high-level trials using the SPIRIT and CONSORT statement in the designment of a study

protocol. The existing evidence also encourages clinicians and researchers to find a

treatment method for tinnitus that is more effective than the evidence-based treatments

currently available.

1.2.3 EYE MOVEMENT DESENSITIZATION AND REPROCESSING

Eye Movement Desensitization and Reprocessing is a psychotherapeutic, evidence-

based treatment, developed in 1987 by Francine Shapiro (Shapiro 2017). EMDR

represents a specific method within a broader theoretical model, called the "Adaptive

Information Processing" (AIP) – model. This term refers to the innate capacity of the brain

to process difficult life experiences and stimuli to achieve an adaptive integration. The AIP

model states that certain experiences or psychological trauma can result in a blockage in

the information processing system of the brain. Specific methods, such as EMDR, can be

a catalyst to effectively integrate information that leads to rapid and adaptive processing

of the trauma (Shapiro 2017). An eight – phase protocol provides the clinical framework

to guide EMDR therapy (Figure 1.6). During the first phase the History taking and Treatment

plan is the main focus. In this phase negative thoughts and experiences will be made

salient. In the second phase, the Preparation phase, stabilization techniques such as

inducing a “safe place” are introduced. In the Assessment phase the clinician addresses

the components of the ‘target’ identifying the main complaints. The negative belief,

147260 Luyten BNW.indd 50 22-12-2020 13:54 GENERAL INTRODUCTION

emotional and physical sensations about the onset-complaints will be made concrete. The

patient will rate the amount of distress using the Subjective Units of Disturbance Scale

(SUDS) ranging from 0 to 10 (0 = neutral to 10 = the worst disturbance imaginable) and

the strength of the desired belief by using the Validity of Cognition scale (VOC) with a range

of 1–7 (1 = completely false to 7 = completely true). In the following phases, i.e. the

Desensitization and Installation phase and Body Scan, bilateral stimulation will be utilized

to activate the traumatic network and reach desensitization and reprocessing of the target

and associated information. Bilateral stimulation is induced by using repetitive eye

movements, auditory signals and / or tactile vibrations. During these phases the clinician

will monitor how the patient is processing information. In the Closure and Reevaluation

phase the patient’s stability is assured and the distress level and positive treatment effects

will be evaluated.

PHASE 1 History & Treatment Plan

PHASE 8 PHASE 2 Reevaluation Preparation

PHASE 3 PHASE 7 Closure Assessment

PHASE 6 Body PHASE 4 Scan Desensitization

PHASE 5 Installation

FIGURE 1.6: ILLUSTRATION OF THE EIGHT PHASES OF EMDR. FIGURE BASED ON THE ORIGINAL EMDR PROTOCOL OF SHAPIRO (2017).

147260 Luyten BNW.indd 51 22-12-2020 13:54 GENERAL INTRODUCTION

EMDR was originally developed to treat post-traumatic stress disorder (PTSD) based on

the experience that traumatic memories can be reduced by saccadic eye movements.

Currently, EMDR is recommended as first line psychotherapy and empirically supported

treatment for PTSD (WHO 2013). Furthermore, evidence supports the efficacy of EMDR

in the treatment of somatoform disorders (i.e. phantom limb pain and chronic pain)

(Schneider, Hofmann et al. 2007, Van Rood and De Roos 2009, Tesarz, Leisner et al.

2014).

Here lies relevance for the implication of EMDR in the treatment of tinnitus since research

has compared tinnitus to phantom limb pain as being a phantom sound (De Ridder,

Elgoyhen et al. 2011). Similarities have been observed in the processing of information in

the absence of the actual physical part in the body and the perception of its present neural

firing (De Ridder, Vanneste et al. 2014). Shapiro stated that experiencing pain while the

limb is absent, can be identified as a dysfunctional manifestation of the stored somatic

memory (Shapiro 2001). EMDR-treatment can effectively target and restore the somatic

memory and pain sensations. The approach of tinnitus as auditory or acoustic trauma calls

for the necessity of effective information processing. Developing new neural networks that

restore the tinnitus as a neutral and non – threatening sound can be generated through

EMDR.

This treatment specifically promotes the plasticity of the brain, allowing neural networks to

be adapted and new neural networks to emerge (Khalfa and Touzet 2017). Furthermore,

evidence for the efficacy of EMDR in the treatment of tinnitus can also be found in

neurobiological studies (Nardo, Högberg et al. 2010, Pagani, Di Lorenzo et al. 2011,

147260 Luyten BNW.indd 52 22-12-2020 13:54 GENERAL INTRODUCTION

Pagani, Högberg et al. 2013, Calancie, Khalid‐Khan et al. 2018, Landin-Romero, Moreno-

Alcazar et al. 2018). EMDR was the first structured psychotherapy to demonstrate

neurobiological effects i.e. altered brain wave activity after treatment (Pagani, Di Lorenzo

et al. 2012) and involvement of the default mode network (DMN), hippocampus, inferior

parietal lobe, medial prefrontal cortex, posterior cingulate cortex, dorsolateral prefrontal

cortex, and orbitofrontal cortex (Calancie, Khalid‐Khan et al. 2018). Interestingly,

considerable overlap can be found in previously determined tinnitus networks e.g.

hippocampus, parahippocampus, anterior insula, amygdala, subgenual and dorsal

anterior cingulate cortex, parietal cortex, posterior cingulate cortex and precuneus, and

prefrontal cortex (De Ridder, Elgoyhen et al. 2011, Vanneste, Van de Heyning et al. 2011).

Studies have also established the role of the DMN in the perception of chronic tinnitus

distress (Schmidt, Akrofi et al. 2013, Schmidt, Carpenter-Thompson et al. 2017, Chen,

Chen et al. 2018) suggesting the effectivity of tinnitus treatments that target the increase

of the connectivity of limbic regions with auditory and attention networks and enhance

coherence of the DMN (Schmidt, Akrofi et al. 2013). EMDR could influence these

connections and facilitate the development of neural networks. However, in the past

evidence was lacking on the use of EMDR in the treatment of tinnitus. Recently, two pilot

studies have been published showing promising results for EMDR as treatment for tinnitus

(Rikkert, Van Rood et al. 2018, Phillips, Erskine et al. 2019). EMDR may be an effective

treatment method for patients with subjective tinnitus, but further research is required to

investigate the effectivity in a lager sample within a randomized controlled design.

147260 Luyten BNW.indd 53 22-12-2020 13:54 GENERAL INTRODUCTION

Meta-analyses on the comparison between EMDR and CBT in PTSD concluded that both

therapies are equally efficacious and that certain patients are more likely to benefit from

one treatment or another (Seidler and Wagner 2006, Bisson, Ehlers et al. 2007). Research

is suggested to further explore mechanisms of action in the treatment of tinnitus and to

address issues of efficiency and treatment differences. Due to the high heterogeneity in

the tinnitus population and the boundless variability of tinnitus impairments, a major

diversity of treatment needs exists.

147260 Luyten BNW.indd 54 22-12-2020 13:54 GENERAL INTRODUCTION

1.3 RESEARCH OBJECTIVES

With the purpose of providing several responses to current research questions, a

comparative randomized controlled trial investigating the effectivity of EMDR and CBT, has

been designed, and conducted. This doctoral thesis consists of the following objectives:

• To describe EMDR and examine the efficacy of EMDR in the treatment of tinnitus.

• To analyze the effect of EMDR compared to CBT in chronic subjective tinnitus

patients.

• To assess whether a bimodal therapy for chronic subjective tinnitus consisting of

the combination of TRT and EMDR results in a clinically significant different

efficacy in comparison with the prevailing bimodal TRT and CBT therapy.

• To explore the influence of specific personality traits in therapeutic outcome.

1.4 THESIS OUTLINE

The present dissertation consists of three main parts covering the research objectives. In

part one, evidence for the effectivity of EMDR as treatment for tinnitus is discussed by use

of a systematic review. The second part presents the randomized controlled trial

completed for this doctoral thesis. In the last part, predictive personality traits for perceived

tinnitus distress and treatment outcome are evaluated.

147260 Luyten BNW.indd 55 22-12-2020 13:54 GENERAL INTRODUCTION

PART I THE VALUE OF EMDR IN THE TREATMENT OF TINNITUS

Chapter 2 consists of a systematic review including two eligible experimental studies

containing data of a total of 49 tinnitus patients. PRISMA guidelines were respected and

the quality assessment was performed using the Platinum Standard, a comprehensive

tool developed to assess the methodological quality of EMDR studies. The therapeutic

effects of EMDR as treatment for chronic subjective tinnitus were explored.

PART II A RANDOMIZED CONTROLLED TRIAL FOR EMDR IN TINNITUS

In Chapter 3 the study protocol for a randomized controlled trial is presented. The protocol

proposes randomization of a total of 166 patients with subjective, chronic, non-pulsatile

tinnitus in two treatment groups: a group receiving TRT and CBT versus a group receiving

TRT and EMDR. Scores on several tinnitus questionnaires (i.e. Tinnitus functional Index

(TFI), Tinnitus Questionnaire (TQ), Visual Analogue Scale of tinnitus loudness (VASLoudness),

Hospital Anxiety and Depression Scale (HADS), and Hyperacusis Questionnaire (HQ)),

psychoacoustic measurements and Event-related potentials (ERP) served as outcome

measures to investigate therapeutic effect.

Chapter 4 discusses the implementation of the bimodal therapy EMDR and TRT versus

the bimodal therapy CBT and TRT. Data of 91 patients with subjective, chronic, non-

pulsatile tinnitus were randomized in the two treatment groups. Evaluations took place at

three time points: pre-treatment, post-treatment and follow up. Data retrieved from the

standardized tinnitus questionnaires and psychoacoustic measurements were analyzed.

147260 Luyten BNW.indd 56 22-12-2020 13:54 GENERAL INTRODUCTION

Furthermore, the Global Perceived Effect (GPE) was implemented to evaluate the sense

of improvement experienced by each individual patient.

PART III INFLUENCING FACTORS IN TINNITUS TREATMENT

In Chapter 5 a retrospective analysis, performed on the data of 82 tinnitus patients treated

with TRT/CBT and TRT/EMDR, is discussed. To examine the effect of Big Five Inventory-

II (BFI-II) traits on tinnitus distress, measured by the Tinnitus Functional Index (TFI), a multiple

regression analysis and a k-means cluster analysis were performed.

147260 Luyten BNW.indd 57 22-12-2020 13:54 147260 Luyten BNW.indd 58 22-12-2020 13:54

147260 Luyten BNW.indd 59 22-12-2020 13:54

147260 Luyten BNW.indd 60 22-12-2020 13:54

THE VALUE OF EMDR IN THE TREATMENT OF TINNITUS

PART I

THE VALUE OF EMDR IN THE TREATMENT OF TINNITUS

I Part

147260 Luyten BNW.indd 61 22-12-2020 13:54

147260 Luyten BNW.indd 62 22-12-2020 13:54

EYE MOVEMENTCHAPTER TWO DESENSITIZATIONEYE MOVEMENT REPROCESSING IN THE DESENSITIZATION TREATMENT OF CHRONIC SUBJECTIVEREPROCESSING TINNITUS: IN THE A SYSTEMATIC2 TREATMENT REVIEW OF CHRONIC

SUBJECTIVE TINNITUS:

A SYSTEMATIC REVIEW

Published in Journal of EMDR Practice and Research

Luyten, T., Van Rompaey, V., Van de Heyning, P., Van Looveren, N., Jacquemin, Luyten, T., Van Rompaey, V., Van de Heyning, P., Van Looveren,L., Cardon, N., E., Jacquemin, Declau F., Fransen,L., Cardon, E., E.,De Bodt, M., & Gilles, A. 2020. Eye DeclauMovement F., Fransen, Desensitization E., De Bodt, Reprocess M., & Gilles,ing in A.the treatment of chronic subjective

tinnitus: A Systematic Review. Journal of EMDR Practice and Research, Volume Published in Journal of EMDR Practice and Research Eye 4,Movement Number Desensitization 3, 135-149 .Reprocessing in the treatment of chronic subjective tinnitus: A Systematic Review. Journal of EMDR Practice and Research, Volume 4, Number 3, 135-149, 2020. 2 Chapter

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147260 Luyten BNW.indd 64 22-12-2020 13:54 CHAPTER 2

2. EYE MOVEMENT DESENSITIZATION REPROCESSING IN THE TREATMENT OF CHRONIC SUBJECTIVE TINNITUS: A SYSTEMATIC REVIEW

ABSTRACT

Introduction: The aim of the current systematic review is to examine the efficacy of EMDR

therapy as treatment for chronic subjective tinnitus. Insights concerning the EMDR

treatment method and the mechanisms could offer valuable therapeutic guidelines in

tinnitus management.

Methods: The systematic review was performed according to the PRISMA guidelines.

PubMed (MEDLINE), the Cochrane Library, PSYNDEX, PsycINFO, and the Francine

Shapiro Library were used as data sources. Included were studies with at least two

patients with diagnosed chronic subjective tinnitus, with pre- and post- measurements,

testing the effect of EMDR.

Results: Two experimental studies with a total of 49 tinnitus patients met the inclusion

criteria. Both studies assessed tinnitus distress. The pre – post treatment effect size of the

studies was calculated in one study (a medium between-effect size of Cohen’s dz = .72).

The other eligible study described significant improvement in 64.3% of the participants.

No adverse events or side effects were reported.

Conclusions: Research on the application of EMDR as treatment for tinnitus is still in an

early stage. Both studies present EMDR as effective treatment for tinnitus distress, at least

for about 50% of the patients and that the effect remains at 3 months follow up.

Recommendations for future research are provided.

147260 Luyten BNW.indd 65 22-12-2020 13:54 CHAPTER 2

2.1 INTRODUCTION

Several researchers have been using EMDR as treatment method to alleviate tinnitus

complaints. Taking into account the high economic and societal cost, in addition to the

significant impact on the quality of life of tinnitus patients, the pressure is on clinicians to

find an effective, evidence-based treatment. Therefore, EMDR could offer a promising

monodisciplinary treatment that is cost efficient. This could lead to adapting current

recommendations and guidelines when new information becomes available. Gathering

persuasive evidence could therefore be one of the first steps to provide effective tinnitus

management in the future.

2.1.1 Tinnitus: Definition, Prevalence and Causes

Tinnitus is known as the perception of sound without the presence of an external auditory

input (De Ridder, Elgoyhen et al. 2011) which can affect one’s quality of life to a great

extent. These auditory sensations are often reported as sizzling, hissing or ringing

(Baguley, McFerran et al. 2013) and can be subjective or objective. Objective tinnitus can

be attributed to an internal source such as the hearing of blood flow and muscle

contractions, whereas subjective tinnitus is known as ‘phantom sound’ where no external

sound source is detectable. The prevalence of subjective tinnitus is estimated between

10 – 15% in the adult population, but 8-20 % of the cases develop chronic subjective

tinnitus (Baguley, McFerran et al. 2013). For a great proportion of patients these sensations

are not perceived as bothersome. However, for about 1-3 % of these patients tinnitus has

considerable impact on one’s quality of life (Baguley, McFerran et al. 2013).

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Tinnitus can be caused by a range of underlying pathologies and conditions. In about 50%

of the cases tinnitus is associated with otologic syndromes, i.e. hearing loss, acoustic

neurinoma, Meniere’s disease, noise trauma, otosclerosis (Gilles, Goelen et al. 2014).

Reactions to ototoxic substances and medication, psychogenic conditions such as

anxiety, depression or emotional trauma, neurologic disorders (e.g. epilepsy, meningitis,

migraine, or head injury), or somatic (e.g. temporomandibular joint or cervical spine) and

metabolic diseases (e.g. hyperthyroidism), might also elicit and/or increase tinnitus

(Baguley, McFerran et al. 2013). This limited enumeration highlights the importance of a

specialized multidisciplinary diagnostic assessment (Van de Heyning, Gilles et al. 2015).

2.1.2 Tinnitus and Comorbidity

Tinnitus distress is associated with psychological symptoms, including sleep deprivation,

concentration problems, depression and anxiety (Zöger, Svedlund et al. 2006, Belli, Belli

et al. 2008, Langguth, Kreuzer et al. 2013). As a consequence leave of absence, work

interruption or resignation, reduced social integration, social isolation, and avoidance of

daily activities tend to occur (Stouffer and Tyler 1990, Halford and Anderson 1991,

Erlandsson, Hallberg et al. 1992) .

The impact of tinnitus on the life of patients and the associated psychological symptoms

results in significant costs for the affected individual and society. A previous cost study

estimated a mean societal cost of tinnitus of €6.8 billion in The Netherlands causing a

substantial economic burden. Furthermore, severity and duration of tinnitus, age, and co-

occurring depressive complaints were determined as important predictors for costs made

147260 Luyten BNW.indd 67 22-12-2020 13:54 CHAPTER 2

by the patients (Maes, Cima et al. 2013). The high economic burden is inextricably linked

to the absence of a uniformly effective treatment for tinnitus.

2.1.3 Evidence-Based Treatment

To date, existing systematic reviews on tinnitus treatments (e.g. Tinnitus Retraining

Therapy (TRT), Cognitive Behavioral Therapy (CBT), repetitive transcranial magnetic

stimulation (rTMS), hyperbaric oxygen therapy, sound therapy, hearing aids) do not

indicate uniformity for the most effective treatment for tinnitus (Schlee, Hall et al. 2018).

Schlee et al. stated that no consensus has been made on therapeutic outcome measures

and study designs. The European tinnitus treatment guidelines suggest a stepped care

approach with psychoeducation and audiological interventions as first steps and

specialized multidisciplinary Cognitive Behavioral Therapy for tinnitus (CBT4T) as a next

step (Cima, Mazurek et al. 2019).

However, also with these recommended interventions, not all patients report sufficient

reduction of the tinnitus complaints or obtain the persistence of positive treatment effects

(i.e. decrease in tinnitus impairment and tinnitus severity) over time.

The heterogeneity of the tinnitus population makes defining the most effective therapeutic

trajectory challenging and research on which interventions are most effective for which

patient even more puzzling. EMDR raises a new light on tinnitus management and can be

a promising treatment method for patients with chronic subjective tinnitus.

2.1.4 EMDR in the Treatment of Tinnitus

Zengin was the first clinician to propose Eye movement desensitization and reprocessing

(EMDR) for reducing tinnitus distress (Zengin 2009). EMDR was originally developed by

147260 Luyten BNW.indd 68 22-12-2020 13:55 CHAPTER 2

Shapiro in 1987 (Shapiro 2017). There is strong empirical support for its use in the

treatment of posttraumatic stress disorder (PTSD), with recognition by many international

bodies such as the World Health Organization (2013). This scientifically based treatment

is characterized by an eight–phase protocol containing the history taking, preparation

phase, assessment phase, desensitization phase where the use of bilateral stimulation is

the key element, installation phase, body scan, closure and reevaluation phase (Shapiro

2018).

This psychotherapeutic approach is guided by the theoretical model called ‘Adaptive

Information Processing’ (AIP). The AIP model asserts that our brains have the inherent

ability to process life experiences and achieve an adaptive solution. However,

psychological trauma can cause obstructions in the brain’s information processing

system, resulting in presenting symptoms. This model indicates that EMDR can enhance

effective information processing of these memories, leading to a rapid and adaptive

processing of the trauma and resolution of the presenting problems (Solomon and

Shapiro 2008). Shapiro (2001) stated that phantom pain, e.g. the experiencing of pain

while the limb is absent, can be perceived as a dysfunctional manifestation of the stored

somatic memory. EMDR-treatment can target and restore the somatic memory and pain

sensations. Tinnitus may be similar to phantom limb pain as tinnitus is considered a

phantom sound (De Ridder, Elgoyhen et al. 2011). Evidence has been found for the

efficacy of EMDR in the treatment of somatoform disorders (i.e. phantom limb pain and

chronic pain) (Van Rood and De Roos 2009). These disorders have been studied in the

context of EMDR and data showing promising results especially for phantom limb pain

(Schneider, Hofmann et al. 2007, Tesarz, Leisner et al. 2014). Recently a number of

147260 Luyten BNW.indd 69 22-12-2020 13:55 CHAPTER 2

researchers have concentrated on using EMDR as treatment for tinnitus. The aim of the

current review is to examine the efficacy of EMDR therapy in the treatment of tinnitus and

to explore the implications for future clinical trials.

2.2 METHOD

2.2.1 Selection of Studies

A systematic review according to the Preferred Reporting Items for Systematic Reviews

and Meta-Analyses (PRISMA) - guidelines was performed (Moher, Shamseer et al. 2015)

(Fig 2.1). An electronic search was performed to identify existing studies using PubMed

(MEDLINE), the Cochrane Library, PSYNDEX, PsycINFO and the Francine Shapiro Library.

The search string consisted of the following keywords: (“EMDR” [Title/Abstract] OR “Eye

Movement Desensitization Reprocessing” [Title/Abstract]) AND (tinnitus). There were no

limitations applied on language or publication date. Two researchers (TL, AG) performed

the search independently and the last search was carried out on 17 September 2019. In

addition, hand searching of reference lists was carried out.

2.2.2 Inclusion and Exclusion Criteria

The following predefined inclusion criteria were applied to perform the eligibility

assessment run by TL and AG. Eligibility criteria are reported using the PICOS – acronym:

Participants: The study population includes human patients with diagnosed chronic

subjective tinnitus by an ENT specialist. The study includes more than two patients.

Intervention: Phenomenon of interest is the use of EMDR intervention.

147260 Luyten BNW.indd 70 22-12-2020 13:55 CHAPTER 2

Comparator: There were no restrictions applied. The study implies a design that uses

EMDR as active treatment.

Outcome: Measurements that assess tinnitus distress and quality of life were considered

relevant for this review.

Study design: All clinical trials were included for this review that reported pre-post

assessment results of EMDR intervention. Case studies reporting on a single patient were

not included in the analysis.

2.2.3 Data extraction

The following data were selected from each study: (1) demographic characteristics of the

study population, (2) inclusion and exclusion criteria of the study, (3) population sample

size, (4) tinnitus assessment, (5) characteristics of the EMDR treatment (setting, protocol,

targets, mode of delivery and therapist), and (6) results of the application of EMDR

treatment on patients with chronic subjective tinnitus. All publications were screened for

safety aspects and adverse aspects. The data extraction sheet was drafted by one review

author (Hertlein and Ricci) and further developed by TL and AG independently of each

other. No disagreement was found between the completed extraction sheets.

2.2.4 Quality assessment

The quality assessment of each study was conducted using the Platinum Standard

(Hertlein and Ricci 2004). This assessment tool was developed to investigate

methodological quality of EMDR studies. The efficacy of EMDR research is the main focus

of this comprehensive assessment tool. A total of 13 criteria were used to analyse the

treatment specific aspects of EMDR: clearly defined target symptoms; reliable and valid

147260 Luyten BNW.indd 71 22-12-2020 13:55 CHAPTER 2

measures; use of blind evaluators; information regarding an assessor’s training;

manualized, replicable, and specific treatment; random assignment; treatment adherence;

non-confounded conditions; use of multimodal measures; length of treatment; level of

therapist training; use of a control group; and effect size reporting (Hertlein and Ricci 2004).

Two authors (TL and AG) conducted the quality assessment independently and reached

consensus. The rating scale was applied by using the checklist and providing three

answer options to score the items i.e. 0, 0.5 and 1 (Hertlein and Ricci 2004). The total

score determined the quality as good (total > 9), fair (< 8 £ 5) or poor (<5). Following the

guidelines formulated in the systematic review on assessment tools (Wang, Taylor et al.

2019) not only an overall score is reported, but all 13 domains are presented. The overview

of this assessment is illustrated in Table 1.

2.3 RESULTS

2.3.1 Types of Studies

The search on the electronic databases resulted in 15 records in total. An overview of all

records is listed in Appendix A. One additional record was obtained by manual scanning

of the reference list of the published study of Phillips et al. (Phillips, Erskine et al. 2019).

After adjusting for duplicates, 8 records were identified. One newsletter, three conference

proceedings, and one study protocol were excluded. The full text of the remaining three

articles was analysed and eligibility criteria were applied. One study did not meet the

inclusion criteria (Zengin 2009), because no tinnitus-related measurements were used,

and no referral was found for a diagnosis of chronic subjective tinnitus made by an ENT

specialist.

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FIGURE 2.1: PREFERRED REPORTING ITEMS FOR SYSTEMATIC REVIEWS AND

META-ANALYSES FLOW DIAGRAM OF STUDY INCLUSION (Moher, Shamseer et al.

2015)

2.3.2 Participants

In total two studies reporting on a total of 49 tinnitus patients matched the inclusion criteria

(Rikkert, Van Rood et al. 2018, Phillips, Erskine et al. 2019). These trials are displayed in

Table 2. Both studies report data from a population consisting of patients with chronic

subjective tinnitus.

147260 Luyten BNW.indd 73 22-12-2020 13:55 CHAPTER 2

2.3.3 Quality of included studies

The methodology of the analyzed articles was of fair to good quality according to the

Platinum Standard. In Table 1 the distinct criteria are defined and linked to the scores to

evaluate EMDR studies. To guarantee validity and transparency, each criterion is reported

separately.

TABLE 1 Quality assessment according the Platinum Standard

Description criteria Rikkert et Phillips et al, 2018 al, 2019 1. Clearly defined target symptoms

0: no clear diagnosis or symptom definition 0.5: not all participants meet target symptom criteria 1.0: all participants meet target symptom criteria 1 1 2. Reliable and valid measures

0: did not use reliable and valid measures 0.5: measures used inadequate to measure change 1.0: reliable, valid, and adequate measures used 1 1 3. Use of blind, independent assessor

0: assessor was therapist

0.5: assessor was not blind 0.5 1.0: assessor was blind and independent 1 4. Assessor reliability

0: no training in administration of instruments used in the study 0.5: training in administration of instruments used in the study 0.5 1.0: training with performance supervision, or reliability checks 1 5. Manualized, replicable, specific treatment

0: treatment was not replicable or specific 0.5: treatment replicable and specific but not standard EMDR protocol (Shapiro 1995) 0.5

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1.0: treatment followed EMDR training manual (Shapiro 1995) 1 6. Unbiased assignment to treatment

0: assignment not randomized 0 0 0.5: only one therapist or other semi- randomized designs 1.0: unbiased assignment to treatment 7. Treatment adherence

0: treatment fidelity poor

0.5: treatment fidelity variable or self-monitored by therapist only 0.5 1.0: treatment fidelity independently checked and adequate 1 8. Nonconfounded conditions (e.g., concurrent psychotherapy or psychopharmacology, violent household, etc.) 0: most participants exposed to confounds with no control for variables 0.5: few participants exposed to confounds with no control for variables 1.0: confounds non-existent or controlled for (e.g., exclusion, matched assignment, etc.) 1 1 9. Use of multimodal measures

0: self-report measures only 0 0.5: self-report plus interview of physiological or behavioural measures 0.5 1.0: self-report plus two or more other types of measures 10. Length of treatment

0: 1-6 sessions 0 0.5: 7-10 sessions 0.5 1.0: 11+ sessions 11. Reported level of therapist(s) training

0: no qualifications for treating clinicians provided 0.5: qualifications for treatment group, clinicians provided 1.0: qualifications for treatment and comparative group, clinicians provided 1 1 12. Use of control or comparison group

0: No use of a wait control/comparison group 0 0.5: Use of a comparison group but no control

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CHAPTER 2 CCHHAAPPTTEERR 2 1.0: Use of a no-treatment control group 1 1.0:13. EffectUse of sizea no -reportingtreatment control Therapist:Number of CHAPTER 2 group 1 clinical sessions: 13. Effect size reporting psychologistsmaximum of 6 0: No effect size reported 0 Number of accreditedweekly sessionssessions: of 90 0:1.0: No Effect effect size reported 0 EMDR 1 minutesmaximum of 6 practitionersweekly 1.0:Total Effect score size reported Therapist: 1 10.5 6.5 Author, EMDR Sample Inclusion Exclusion Outcome Study Author’s clinicalsessions of 90 Total score 10.5 6.5 year Protocol apsychologistsminutesnd size criteria criteria Measures design Conclusions NOTE: PLATINUM STANDARD ASSESSMENT TOOL WITH THE RATING SCALE Targets accreditedTherapist: p atient clinical NOTE: PLATINUM STANDARD ASSESSMENT TOOL WITH THE RATING SCALE EMDR group PROVIDING THREE ANSWER OPTIONS TO SCORE THE ITEMS (0, 0.5 AND 1) Phillips Protocol: practitionerspsychologists14 (7 Age ³ 18 Mental health Primary Prospective Clinically and accredited PROVIDING THREE ANSWER OPTIONS TO SCORE THE ITEMS (0, 0.5 AND 1) et al, PhillipstEMDR - Protocol: males, 14 (7 Age ³ 18problems Mental health outcome:Primary clinicalProspectiv trial, statisticallyClinically EMDR ACCORDING TO HERTLEIN, K. M., & RICCI, R. J. (2004). A SYSTEMATIC RESEARCH 2019 etprotocol al, tEMDR- 7 males,THI > 38 problems THI outcome: no econtrol clinical significantand practitioners ACCORDING TO HERTLEIN, K. M., & RICCI, R. J. (2004). A SYSTEMATIC RESEARCH 2019 protocol 7 £ THI > 38 THI trial, no statistically developed to female) 100 ³ Difficulty Others: group improvement SYNTHESIS OF EMDR STUDIES: IMPLEMENTATION OF THE PLATINUM STANDARD. Phillips developedProtocol: to fem14 (7ale) £Age 100 18 DifficultyMental health Others:Primary controlProspectiv significantClinically SYNTHESIS OF EMDR STUDIES: IMPLEMENTATION OF THE PLATINUM STANDARD. ettreat al, tEMDR- males, communicatingproblems BDI,outcome: e clinical inand tinnitus treat communicatin BDI, group improvemen 2019individuals protocol with Mean 7 Diagnosis English BAI THI trial, no symptoms;statistically TRAUMA, VIOLENCE, & ABUSE, 5(3), 285-300. individuals with Mean DiagnosisTHI > 38 g English BAI t in tinnitus TRAUMA, VIOLENCE, & ABUSE, 5(3), 285-300. tinnitus age = tinnitus£ > Follow treatment tinnitusdeveloped to agefem ale)= tinnitus 100 > Difficulty FollowOthers: control symptoms;significant Targets: treat 57 6 months communicatin up: BDI, group effectsimprovemen Targets: 57 6 months up: treatment tinnitus-relatedtinnitusindividuals -related with Mean Diagnosis g English 6 months6BAI months maintainedeffectst in tinnitus experiences,tinnitus ageSubjective, = tinnitus > Follow atsymptoms; follow-up 2.3.4 DemographicDemographic information information experiences, Subjective maintained and traumaandTargets: trauma 57 idiopathic,6 idiopathic months up: attreatment follow-up tinnitus-related 6 months effects psychologicallypsycho logicall tinnitustinnitus TABLE 2 2 Characteristics Characteristics of ofthe the included included studies studies linked to theyexperiences, linked to the Subjective maintained and trauma , idiopathic at follow-up tinnitus tinnitus Author EMDR Sampl Inclusion Exclusion Outcome Study Author’s psychologicall tinnitus Author, EMDR Sample Inclusion Exclusion Outcome Study Author’s , year Protocol and e size criteria criteria Measure design Conclusions y linked to the year Protocol and size criteria criteria Measures design Conclusions Bilateral Bilateral Targets patient s stimulation:tinnitus Targets patient stimulation: group eye group eye Rikkert Protocol: 35 (19 Age ³ 18 Mental health Primary Prospectiv Clinical and movementsBilateral Rikkert Protocol: 35 (19 Age ³ 18 Mental health Primary Prospective Clinical and movements et al, EMDR males, £ 65 problems outcome: e clinical statistically andstimulation: pulsators et al, EMDR males, £ 65 problems outcome: clinical trial, statistically 2018 standard 16 (acute medical TFI trial, within- significant and pulsatorsNumbereye of 2018 standard 16 (acute medical TFI within- significant protocol female) TFI ³ 54 or psychiatric Others: group improvemen Number ofsessions:movements Targets:protocol female) TFI ³ 54 condition)or psychiatric Mini -TQ,Others: design, groupt in tinnitusimprovement sessions: maximumand pulsators of disturbingTargets: Mean Diagnosis condition) SCL-90,Mini -TQ,waiting -listdesign, symptoms; in tinnitus maximum10Number of sessions of of tinnitusdisturbing-related ageMean = tinnitusDiagnosis ³ Difficulty SRIP SCL-condition90, waiting treatment-list symptoms; 10 sessions60sessions: minutes,of maximum of memories,tinnitus-related and 49 age = 6 monthstinnitus ³ communicatin6 Difficulty Follow SRIP as controlcondition effects treatment 60 minutes,one session 10 sessions of traumaticmemories, and 49 months g Dutchcommunicating up: Followgroup as conmaintainedtrol effects one sessionevery 1 to 2 experiences 3 months at follow-up 60 minutes, traumatic Referral Dutch up: group maintained every 1 toweeks 2 that evoked ENT - one session experiences Referral 3 months at follow-up weeks Therapist: feelings of doctor in 1every clinical 1 to 2 that evoked ENT - Therapist: powerlessnes general psychologistweeks feelings of doctor in 1 clinical s hospital accreditedTherapist: powerlessness general psychologistEMDR1 clinical Bilateral Bilateral hospital accreditedpractitionerpsychologist accredited stimulation:stimulation: EMDR eyeeye practitionerEMDR NOTE:practitioner TFI = TINNITUS FUNCTIONAL INDEX, MINI-TQ = MINI – TINNITUS movementsmovements andand pulsators pulsators QUESTIONNAIRE, SCL-90 = SYMPTOM CHECKLIST – 90, SRIP = SELF – RATING Number of NOTE:INVENTORY NOTE:TFI = TINNITUS TFI = LIST TINNITUS FOR FUNCTIONAL POST FUNCTIONAL – TRAUMATIC INDEX, INDEX, MINI STRESS MINI-TQ-TQ = DISORDER, MINI= MINI – TINNITUS– TINNITUS SUDS = sessions: QUESTIONNAIRE,SUBJECTIVE SCLRATINGS-90 = SYMPTOMOF DISTURBANCE, CHECKLIST THI =– 90,TINNITUS SRIP = HANDICAP SELF – RATING QUESTIONNAIRE, SCL-90 = SYMPTOM CHECKLIST – 90, SRIP = SELF – RATING maximum of 6 INVENTORY,INVENTORY BDI LIST = BECK FOR DEPRESSION POST – TRAUMATIC INVENTORY, STRESS BAI DISORDER,= BECK ANXIETY SUDS INDEX = weekly INVENTORY LIST FOR POST – TRAUMATIC STRESS DISORDER, SUDS = SUBJECTIVE SUBJECTIVE RATINGS OF DISTURBANCE, THI = TINNITUS HANDICAP sessions of 90 INVENTORY, BDI = BECK DEPRESSION INVENTORY, BAI = BECK ANXIETY INDEX minutes 76 RATINGS OF DISTURBANCE, THI = TINNITUS77 HANDICAP INVENTORY, BDI = BECK DEPRESSION INVENTORY, BAI = BECK ANXIETY INDEX 76 77

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CHAPTER 2 CCHHAAPPTTEERR 2 1.0: Use of a no-treatment control group 1 CHAPTER 2 1.0:13. EffectUse of sizea no -reportingtreatment control Therapist:Number of CHAPTER 2 group 1 clinical sessions: 13. Effect size reporting psychologistsNumbermaximum of of 6 0: No effect size reported 0 Number of accreditedsessions:weekly sessions:sessionsmaximum of of 90 6 0:1.0: No Effect effect size reported 0 EMDR 1 minutesweeklymaximum of 6 practitionersweekly 1.0:Total Effect score size reported Therapist:sessions of 90 1 10.5 6.5 Author, EMDR Sample Inclusion Exclusion Outcome Study Author’s clinicalminutessessions of 90 Total score 10.5 6.5 year Protocol apsychologistsTherapist:minutesnd size criteria criteria Measures design Conclusions NOTE: PLATINUM STANDARD ASSESSMENT TOOL WITH THE RATING SCALE Targets accreditedclinicalTherapist: p atient clinical NOTE: PLATINUM STANDARD ASSESSMENT TOOL WITH THE RATING SCALE EMDRpsychologists grou p PROVIDING THREE ANSWER OPTIONS TO SCORE THE ITEMS (0, 0.5 AND 1) Phillips Protocol: practitionersaccreditedpsychologists14 (7 Age ³ 18 Mental health Primary Prospective Clinically and accredited PROVIDING THREE ANSWER OPTIONS TO SCORE THE ITEMS (0, 0.5 AND 1) et al, PhillipstEMDR - Protocol:EMDR males, 14 (7 Age ³ 18problems Mental health outcome:Primary clinicalProspectiv trial, statisticallyClinically EMDR ACCORDING TO HERTLEIN, K. M., & RICCI, R. J. (2004). A SYSTEMATIC RESEARCH 2019 etprotocol al, tEMDRpractitioners- 7 males,THI > 38 problems THI outcome: no econtrol clinical significantand practitioners ACCORDING TO HERTLEIN, K. M., & RICCI, R. J. (2004). A SYSTEMATIC RESEARCH 2019Phillips protocolProtocol: 714 (7£ THIAge > ³ 3818 Mental health THIPrimary trial,Prospectiv no statisticallyClinically developed to female) 100 ³ Difficulty Others: group improvement SYNTHESIS OF EMDR STUDIES: IMPLEMENTATION OF THE PLATINUM STANDARD. etPhillips al, developedtEMDRProtocol:- to femmales,14 (7ale) £Age 100 18 DifficultyproblemsMental health Others:outcome:Primary controleProspectiv clinical significantandClinically SYNTHESIS OF EMDR STUDIES: IMPLEMENTATION OF THE PLATINUM STANDARD. ettreat al, tEMDR- males, communicatingproblems BDI,outcome: e clinical inand tinnitus 2019 treatprotocol 7 THI > 38 communicatin BDI,THI grouptrial, no improvemenstatistically 2019individuals protocol with Mean 7 Diagnosis English BAI THI trial, no symptoms;statistically TRAUMA, VIOLENCE, & ABUSE, 5(3), 285-300. individualsdeveloped withto Meanfemale) Diagnosis£THI 100 > 38 gDifficulty English BAIOthers: control tsignificant in tinnitus TRAUMA, VIOLENCE, & ABUSE, 5(3), 285-300. tinnitus age = tinnitus£ > Follow treatment tinnitustreatdeveloped to age fem ale)= tinnitus 100 > communicatinDifficulty FollowBDI,Others: groupcontrol symptoms;improvemensignificant Targets: treat 57 6 months communicatin up: BDI, group effectsimprovemen Targets:individuals with 57Mean 6Diagnosis months g English up:BAI treatmentt in tinnitus tinnitus-relatedtinnitusindividuals - related with ageMean = tinnitusDiagnosis > g English 6 months6FollowBAI months maintainedeffectssymptoms;t in tinnitus experiences,tinnitus ageSubjective, = tinnitus > Follow atsymptoms; follow-up 2.3.4 DemographicDemographic information information experiences,Targets: 57 Subjective6 months up: maintainedtreatment and traumaandtinnitusTargets: trauma-related 57 idiopathic, 6 idiopathic months 6up: months ateffectstreatment follow -up tinnitus-related 6 months effects psychologicallypsychoexperiences, logica ll tinnitustinnitusSubjective maintained TABLE 2 2 Characteristics Characteristics of ofthe the included included studies studies linked to theyandexperiences, linked trauma to the ,Subjective idiopathic atmaintained follow-up and trauma , idiopathic at follow-up tinnitus tinnituspsycho logicall tinnitus Author EMDR Sampl Inclusion Exclusion Outcome Study Author’s psychologicall tinnitus Author, EMDR Sample Inclusion Exclusion Outcome Study Author’s y linked to the , year Protocol and e size criteria criteria Measure design Conclusions y linked to the year Protocol and size criteria criteria Measures design Conclusions Bilateral Bilateraltinnitus Targets patient s stimulation: tinnitus Targets patient stimulation: group eyeBilateral group eye Rikkert Protocol: 35 (19 Age ³ 18 Mental health Primary Prospectiv Clinical and movementsstimulation:Bilateral Rikkert Protocol: 35 (19 Age ³ 18 Mental health Primary Prospective Clinical and movements et al, EMDR males, £ 65 problems outcome: e clinical statistically andeyestimulation: pulsators et al, EMDR males, £ 65 problems outcome: clinical trial, statistically 2018 standard 16 (acute medical TFI trial, within- significant and pulsatorsNumbermovementseye of 2018 standard 16 (acute medical TFI within- significant protocol female) TFI ³ 54 or psychiatric Others: group improvemen Number ofsessions:andmovements pulsators Targets:protocol female) TFI ³ 54 condition)or psychiatric Mini -TQ,Others: design, groupt in tinnitusimprovement sessions: maximumNumberand pulsators of of disturbingTargets: Mean Diagnosis condition) SCL-90,Mini -TQ,waiting -listdesign, symptoms; in tinnitus maximum10sessions:Number of sessions of of tinnitusdisturbing-related ageMean = tinnitusDiagnosis ³ Difficulty SRIP SCL-condition90, waiting treatment-list symptoms; 10 sessions60maximumsessions: minutes,of of maximum of memories,tinnitus-related and 49 age = 6 monthstinnitus ³ communicatin6 Difficulty Follow SRIP as controlcondition effects treatment 60 minutes,one10 sessions session of 10 sessions of traumaticmemories, and 49 months g Dutchcommunicating up: Followgroup as conmaintainedtrol effects one sessionevery60 minutes, 1 to 2 experiences 3 months at follow-up 60 minutes, traumatic Referral Dutch up: group maintained every 1 toweeksone 2 session that evoked ENT - everyone session 1 to 2 experiences Referral 3 months at follow-up weeks Therapist: feelings of doctor in 1weeksevery clinical 1 to 2 that evoked ENT - Therapist: powerlessnes general psychologistTherapist:weeks feelings of doctor in 1 clinical s hospital accredited1Therapist: clinical powerlessness general psychologistEMDRpsychologist1 clinical Bilateral Bilateral hospital accreditedpractitioneraccreditedpsychologist accredited stimulation:stimulation: EMDR EMDR EMDR eyeeye practitionerNOTE:practitioner TFI = TINNITUS FUNCTIONAL INDEX, MINI-TQ = MINI – TINNITUS movementsmovements practitioner QUESTIONNAIRE, SCL-90 = SYMPTOM CHECKLIST – 90, SRIP = SELF – RATING andand pulsators pulsators NOTE: TFI = TINNITUS FUNCTIONAL INDEX, MINI-TQ = MINI – TINNITUS NOTE:INVENTORY NOTE:TFI = TINNITUS TFI = LIST TINNITUS FOR FUNCTIONAL POST FUNCTIONAL – TRAUMATIC INDEX, INDEX, MINI STRESS MINI-TQ-TQ = DISORDER, MINI= MINI – TINNITUS– TINNITUS SUDS = Number of QUESTIONNAIRE, SCL-90 = SYMPTOM CHECKLIST – 90, SRIP = SELF – RATING sessions: QUESTIONNAIRE,SUBJECTIVE SCLRATINGS-90 = SYMPTOMOF DISTURBANCE, CHECKLIST THI =– 90,TINNITUS SRIP = HANDICAP SELF – RATING QUESTIONNAIRE,INVENTORY SCL LIST-90 =FOR SYMPTOM POST – TRAUMATIC CHECKLIST STRESS – 90, SRIP DISORDER, = SELF SUDS – RATING = maximum of 6 INVENTORY,INVENTORY BDI LIST = BECK FOR DEPRESSION POST – TRAUMATIC INVENTORY, STRESS BAI DISORDER,= BECK ANXIETY SUDS INDEX = weekly INVENTORY LISTSUBJECTIVE FOR POST RATINGS – TRAUMATIC OF DISTURBANCE, STRESS DISORDER, THI = TINNITUS SUDS HANDICAP = SUBJECTIVE SUBJECTIVE RATINGS OF DISTURBANCE, THI = TINNITUS HANDICAP sessions of 90 INVENTORY, BDI = BECK DEPRESSION INVENTORY, BAI = BECK ANXIETY INDEX INVENTORY, BDI = BECK DEPRESSION INVENTORY, BAI = BECK ANXIETY INDEX minutes 76 RATINGS OF DISTURBANCE, THI = TINNITUS77 HANDICAP INVENTORY, BDI = BECK DEPRESSION INVENTORY, BAI = BECK ANXIETY INDEX 77 76 77

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The primary and secondary outcome measures are summarized in Table 3. Phillips et al.

did not report effect sizes (Phillips, Erskine et al. 2019). Therefore, the percentage of

patients that showed clinically significant improvement (CSI) were compared. The number

needed to treat (NNT) was reported in the Rikkert study. To make a comparison the NNT

of the Phillips study was calculated and provided in Table 3 as well. This derived statistic

provides an indication of the number of patients that require this treatment for one

additional patient to obtain a positive outcome such as the present treatment response

(Andrade 2015).

TABLE 3 Outcome measurements

AUTHOR, EMDR pre - post YEAR

Mean p value Total Effect Size: % CSI NNT

Difference Cohen’s dz

RIKKERT ET TFI: 18.6 .001 35 TFI: 0.72 Post 1.95 AL, 2018 Mini-TQ: .001 35 Mini-TQ: treatment: 3.94 .05 35 0.71 51.4% SCL-90: SCL-90: Follow up (3 15.91 0.41 months): 51.4% PHILLIPS ET THI: 37.5 .0005 14 THI: / Post 0.82 AL, 2019 BDI: 6.5 .0098 14 BDI: / treatment: BAI: 5 .0625 14 BAI: / 57.1% Follow up (6 months): 64.3%

NOTE: TFI = TINNITUS FUNCTIONAL INDEX, MINI-TQ = MINI – TINNITUS QUESTIONNAIRE, SCL-90 = SYMPTOM CHECKLIST – 90, SRIP = SELF – RATING INVENTORY LIST FOR POST – TRAUMATIC STRESS DISORDER, THI = TINNITUS HANDICAP INVENTORY, BDI = BECK DEPRESSION INVENTORY, BAI = BECK ANXIETY INDEX, NNT = NUMBER NEEDED TO TREAT, CSI = CLINICALLY SIGNIFICANT IMPROVEMENT

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2.4 DISCUSSION OF THE STUDIES

2.4.1 Designs

Both eligible studies applied a pretest-posttest design. No control group was present in

the Phillips study, while in the pilot of Rikkert et al. a wait-list control group was

implemented (Rikkert, Van Rood et al. 2018). The use of a control condition is one of the

criteria proposed by the Platinum Standard to evaluate the methodologic quality of an

EMDR study. This delayed treatment design provides an indication of therapeutic change

and controls for the effects of the passage of time, but it cannot rule out non-specific

effects of treatment such as expectancy and the attention given by a therapist willing to

listen and support the patient. The follow-up assessment differs in timeframe as the follow-

up in the study of Rikkert et al. (2018) was set at three months while in the study of Phillips

et al. (2019) it was set at six months.

2.4.2 Sample Size

There were fourteen patients in the Phillips et al. study and 35 patients in the Rikkert et al.

study. The study population in both prospective clinical trials consisted of diagnosed

tinnitus patients who had no severe mental health problems requiring immediate

psychiatric treatment. Phillips et al. excluded patients who underwent current treatment

from secondary mental health care services and Rikkert et al. excluded patients who

reported an acute medical or psychiatric condition in a telephone interview with a research

assistant.

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2.4.3 EMDR Protocol

The main distinction between the two included studies lies in the used protocols. Rikkert

et al. used the standard EMDR protocol only, whereas Phillips et al. used the standard

protocol to process tinnitus related memories as well but developed another protocol

named “tEMDR” to target current tinnitus. The study population presented symptoms that

were not associated with any trauma history. Rikkert et al. handled a trauma-focused

approach using the standard EMDR protocol and targets that consisted of disturbing

tinnitus-related memories, and traumatic experiences that evoked feelings of

powerlessness. Nevertheless, even though the focus in the Rikkert study was on traumatic

memories, the significant reduction in tinnitus distress could not be explained by reduction

of PTSD symptoms, as there was little decrease in PTSD scores. This indicates that

somatic symptoms, namely tinnitus sensations, can be processed by desensitizing the

emotional associations, memories and experiences.

Length of treatment

Treatment length was comparable in both studies. Six 90-minute sessions versus ten 60-

minute sessions offers 540-600 minutes of therapy. The number of the sessions varied

depending on treatment effect. In the Rikkert study there were early completers,

suggesting that for those patients the treatment time was sufficient. Shapiro (Shapiro

2018) stated that no agreement has been made on the number of sessions. However,

the Platinum Standard proposes a minimum of 10 sessions for application of analyzing

EMDR research (Hertlein and Ricci 2004), even though many successful studies have

used fewer sessions. The developers of the Platinum Standard accepted the rationale of

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Carlson, Chemtob, Rusnak, Hedlund, and Muraoka (1998). One might argue the dated

relevance of this validation, as literature supports evidence for EMDR effectivity in fewer

sessions (De Jongh, Amann et al. 2019). Given the variability in outcome measures, it is

uncertain whether the treatment duration is an influential factor.

Level of Therapist Training

The therapists’ training level and availability of supervision could have an influence on

treatment outcome. The Level II is indicated as favorable to evaluate effectiveness in EMDR

research (Hertlein and Ricci 2004). In the study of Rikkert, the 5 different therapists were

licensed clinical psychologists and advanced practitioners in EMDR of whom were Level

II trained and one was an EMDR Europe Practitioner. All sessions were videotaped and

supervised using a session checklist. In the study of Phillips et al., there was only one

therapist; all patients were treated by one clinical psychologist, trained as EMDR therapist.

Treatment Targets

Both studies processed the disturbing memories associated with tinnitus, even though

their approach seemed different. Phillips et al. focused on the tinnitus-specific experience,

after processing traumatic memories if those were present. When comparing both

protocols, no essential differences were found between the treatment targets. During the

desensitization and reprocessing phase patients were asked to focus on an external

bilateral stimulus e.g. visual (eye movements) or tactile (pulsators). These stimuli were used

in both studies.

147260 Luyten BNW.indd 81 22-12-2020 13:55 CHAPTER 2

Symptom Improvement

No similar outcome measurements were used, however a comparison could be made

based on the percentage of improvement in both pilot studies. Based on the primary

outcome measurements, clinically significant improvement was reached in both studies.

In the Rikkert study 51.4% showed a significant decrease in tinnitus distress after treatment

with a stable effect after the three month follow up. In the Phillips study 57.1% reported

less tinnitus distress after treatment and this effect increased after 6 months post treatment

(64.3%). The NNT calculation resulted in comparable numbers, i.e. 1.95 and 0.82.

Important to point out is the difference in study design, whereas there was no control

group in the Phillips study compared to a waiting list control condition in the research

conducted by Rikkert et al. For this reason, these numbers should be interpreted with

caution within this context.

2.4.4 Primary Outcome Measurements

Tinnitus Functional Index (TFI)

The TFI, developed to assess tinnitus distress and the impact of tinnitus symptoms on

daily life (i.e. intrusiveness, sense of control, cognitive interference, sleeping problems,

hearing problems, relaxation, quality of life and emotional state of mind) (Meikle, Henry et

al. 2012, Fackrell, Hall et al. 2016). This self-report measurement was used in the pilot

study of Rikkert et al. to measure the treatment effect and set a cut-off point for entering

the study (TFI ³ 54 = significant problem) (Rikkert, Van Rood et al. 2018). A decrease of

13 points on the TFI was used as the criterion for clinically significant improvement as

stated by Henry et al. (Henry, Griest et al. 2016). A total of 18 of the 35 patients

147260 Luyten BNW.indd 82 22-12-2020 13:55 CHAPTER 2

experienced clinically significant improvement and this effect remained stable after three

months.

Tinnitus Handicap Inventory (THI)

Instead of the TFI, Phillips et al. utilized the THI (Newman, Jacobson et al. 1996) which is

also implemented to investigate the reduction of tinnitus distress (i.e. functional,

catastrophic and emotional subscales) after treatment (Phillips, Erskine et al. 2019). A drop

of 20 on the total THI score is set to indicate a significant improvement (Newman,

Jacobson et al. 1996). A total of 8 of the 14 patients reported significant improvement

after treatment and 9 patients experienced positive treatment effect after 6 months.

According to the primary outcome measures clinically significant effects can be found at

p = .01 level in both studies. Rikkert et al. reported a medium between-effect size (pre-

posttreatment) of Cohen’s dz = .72. The compared this effect size with those reported in

the randomized controlled trial on CBT for tinnitus patients conducted by Cima et al. (2012)

which led to small effect sizes (Cohen’s dz = .20 - .32) for usual care after three months

and moderate medium effect sizes (Cohen’s dz = .41 - .52) for specialized care. The

studies of Rikkert et al. and Phillips et al. show stable effects after follow-up on the primary

outcome measurements.

2.4.5 Secondary Outcome Measurements

As for the secondary measurements no parallel can be made between the two eligible

studies. The Mini-Tinnitus Questionnaire, Symptom Checklist-90 and Self-Rating Inventory

List for Post-traumatic Stress Disorder were implemented in the study of Rikkert et al.

147260 Luyten BNW.indd 83 22-12-2020 13:55 CHAPTER 2

(Rikkert, Van Rood et al. 2018). Phillips et al. chose to assess depressive and anxiety

symptoms using the Beck Depression Inventory and the Beck Anxiety Inventory

respectively (Phillips, Erskine et al. 2019).

Mini – Tinnitus Questionnaire (Mini – TQ)

To validate earlier findings, the Mini-TQ (Hiller and Goebel 2004) was implemented in the

Rikkert study. In this self-report measurement, tinnitus distress was scored based on these

specific domains i.e. emotional and cognitive distress, intrusiveness, sleep disturbances,

somatic complaints and auditory perceptual difficulties. A significant decrease in tinnitus

distress was detected after EMDR treatment.

Symptom Checklist-90 (SCL-90)

This checklist was developed to make an assessment of psychological stress (Arindell

and Ettema 1986) and was used in the Rikkert study. A significant statistical decrease in

psychological stress was found after the EMDR intervention.

Self-Rating Inventory List for Post-traumatic Stress Disorder (SRIP)

This questionnaire was used in the Rikkert study to score the symptoms of Post-Traumatic

Stress Disorder according to the Diagnostic and Statistical Manual of Mental Disorders,

4th Edition (DSM-IV) (APA 2000). Over time, only a minimal decrease in SRIP scores was

found. No significant effect was detectable. Therefore, the reduction of tinnitus distress

could not be explained by a reduction of PTSD symptoms.

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Beck Depression Inventory (BDI)

The BDI was used in the Phillips study to measure the severity of depression (Beck, Steer

et al. 1996). This is no diagnostic tool but gives an indication of depressive symptoms.

These scores show a significant decrease of depressive symptoms after treatment with a

reduction of seven points (p = .0098). This effect was maintained after six months.

Beck Anxiety Inventory (BAI)

The BAI screened for clinical anxiety and assessed symptoms of anxiety (Beck, Epstein et

al. 1988) in the Phillips study. No significant clinically improvement was observed but was

in the line of the expectations as the baseline median anxiety score was considered low.

Still a reduction in symptoms was noticed. The baseline BAI score was 6, after treatment

a decrease was detected (3.5) and at the six month follow up even less symptoms of

anxiety were reported (1.5).

2.4.6 Summary of Strengths and Limitations

2.4.6.1 Strengths of the included studies

All authors reported clinical and statistical improvement in tinnitus symptoms and stable

treatment effects at the last available follow-up. The reviewed studies hold several

strengths. The study of Rikkert et al. demonstrated general applicability of treatment

outcome for the multicenter nature of the trial. These researchers also state that the use

of more than one therapist limits therapist bias. The implementation of a delayed-treatment

group could control for spontaneous recovery and fluctuations over time. The therapists

and included patients were blind to assessment outcomes. A manualized treatment

147260 Luyten BNW.indd 85 22-12-2020 13:55 CHAPTER 2

protocol, session checklists and video-recorded sessions, enhanced treatment reliability.

Additionally, a significant decrease in tinnitus distress was reached after treatment and

was maintained after 3 months. Furthermore, the reported effect sizes were comparable

to earlier tinnitus studies. Assets discussed in the Phillips et al. study were the creation of

a tailored EMDR protocol (tEMDR). The ‘present-oriented focus’ that was used in this

protocol met the needs of the included tinnitus patients. The implementation of tEMDR led

to immediate improvement after treatment and remained stable after six months.

2.4.6.2 Limitations of the included studies

Certain limitations of the reviewed studies are relevant to discuss as this leads us to

implications for future research. The within-group design, used in the Rikkert study, leaves

us questioning whether non-specific effects (e.g. positive attention, hope and expectancy)

explain minor changes. The application of an independent control group was also lacking

in the Philips study. The number of patients was considerable smaller than in the Rikkert

study. Therefore, treatments effect should be interpreted with caution and within this

context. However, these preliminary studies offer clear significance in the clinical field

because more than 50% of the patients obtained significant improvement.

2.4.7 Research implications

This systematic review consists of two relevant studies. Only published articles were

included, indicating that the review is susceptible to publication bias. Due to the

heterogeneity of the outcome measures used in the Rikkert et al. and Phillips et al. studies,

analysis and comparisons are challenging. The variability of assessment tools limits

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retrieving clear evidence on true treatment effects. However, the percentage of

improvement (e.g. 51.4% vs 57.1%) is comparable and an NNT calculation derived scores

(e.g. 1.95 vs 0.82) indicating a similar number of patients needed to treat to obtain

treatment effect for one additional patient (Andrade 2015).

2.4.8 Recommendations for future research

The promising results of both EMDR studies indicate the value of future randomized

controlled trials with an adequate control group, a considerable sample size, and the use

of standardized EMDR procedures. In addition, future research should focus on the use

of not only subjective outcome measurements, but also on the implementation of objective

measurements since no relation has been found between certain tinnitus aspects, such

as tinnitus loudness and tinnitus pitch, and tinnitus distress (Manning, Thielman et al.

2019). Recently a study protocol for a RCT on the value of EMDR in the treatment of

tinnitus has been published (Luyten, Van de Heyning et al. 2019). A comparison between

two bimodal therapies, e.g. the evidence-based control treatment TRT + CBT versus TRT

+ EMDR as experimental treatment, the execution of the original EMDR protocol and the

use of subjective and objective measurements have been implemented in this study.

These data could elaborate on the current insights on the efficacy and working

mechanisms of this treatment on tinnitus patients.

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2.5 CONCLUSION

EMDR has been proposed as a potential treatment for tinnitus patients as positive effects

have been previously reported in two pilot studies. This review indicates that EMDR might

be a promising treatment method for patients with moderate to severe tinnitus complaints.

Furthermore, the somatic sensations, and emotions, experiences and memories

associated with the tinnitus, can successfully be desensitized using EMDR. Replications

using both waiting list and active control conditions are warranted.

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147260 Luyten BNW.indd 90 22-12-2020 13:55

A RANDOMIZED PART II

CONTROLLEDA RANDOMIZED CONTROLLEDTRIAL TRIAL FOR EMDRFOR INEMDR TINNITUS IN TINNITUS

II Part

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147260 Luyten BNW.indd 92 22-12-2020 13:55

CHAPTER THREE THE VALUE OF THE VALUE OF EYE EYE MOVEMENT DESENSITIZATIONMOVEMENT DESENSITIZATION REPROCESSINGREPROCESSING IN THE IN THE

TREATMENTTREATMENT OF TINNITUS: OF TINNITUS : STUDY PROTOCOL 3 STUDY PROTOCOL FOR A FOR A RANDOMIZED CONTROLLEDRANDOMIZED TRIAL CONTROLLED

TRIAL

Published in Trials

Luyten,Luyten, T., Van T., deVan Heyning, de Heyning, P., Jacquemin, P., Jacquemin, L., L., Van Looveren, N., Declau F., Van Looveren, N., Declau F., Fransen, E., & Gilles, A. Fransen, E., & Gilles, A. 2019. The Value of Eye Movement Desensitization

Reprocessing in the treatment of tinnitus: study protocol for a randomized Published in Trials Thecontrolled Value of Eye trial Movement. Trials, Desensitization20(1), 32. Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial. Trials, 20(1), 32, 2019. Chapter

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147260 Luyten BNW.indd 94 22-12-2020 13:55 CHAPTER 3

3. THE VALUE OF EYE MOVEMENT DESENSITIZATION

REPROCESSING IN THE TREATMENT OF TINNITUS:

STUDY PROTOCOL FOR A RANDOMIZED

CONTROLLED TRIAL

ABSTRACT

Introduction: Patients suffering from chronic, subjective tinnitus are on a quest to find a

cure or any form of alleviation for their persistent complaints. Current recommended

therapy forms provide psychotherapeutic interventions that are intended to train the patient

how to deal with the tinnitus sound. Pharmaceutical managements are used to reduce

secondary effects of the tinnitus sound such as sleep deprivation, emotional and

concentration difficulties, but these treatments do not cure the tinnitus. Recent studies

have shown that Tinnitus Retraining Therapy (TRT) significantly improves the quality of life

for tinnitus patients. Furthermore, several studies have reported that cognitive behavioral

therapy (CBT) relieves a substantial amount of distress by changing dysfunctional

cognitions. However, when the tinnitus causes a great interference with daily functioning,

these treatment methods are not always sufficiently effective.

Recent insights show that Eye Movement Desensitization Reprocessing (EMDR) is a highly

effective therapy for medically unexplained symptoms such as chronic pain and phantom

pain. In scientific research, tinnitus is compared to phantom limb pain. Starting from tinnitus

as a phantom percept we therefore aim to demonstrate that the operating mechanisms of

147260 Luyten BNW.indd 95 22-12-2020 13:55 CHAPTER 3

EMDR may also be an effective treatment method for patients with subjective tinnitus.

The aim of this randomized, controlled study with blind evaluator is to examine the effect

of EMDR compared to CBT in chronic tinnitus patients. To our knowledge, there are no

other studies that evaluate both methods simultaneously.

Methods / design: A total of 166 patients with subjective, chronic, non-pulsatile tinnitus

will be randomized in two treatment groups: TRT and CBT versus TRT and EMDR. The

experimental group will receive the bimodal therapy TRT / EMDR and the active control

group will receive the bimodal therapy TRT / CBT. Evaluations will take place at baseline

before therapy, at the end of the treatment and 3 months after therapy. The score on the

Tinnitus Functional Index (TFI) will be used as the primary outcome measurement.

Secondary outcome measurements are the Visual Analogue Scale of Loudness (VAS),

Tinnitus Questionnaire (TQ), Hospital Anxiety and Depression Scale (HADS), Hyperacusis

Questionnaire (HQ), psychoacoustic measurements and Event-related potentials (ERP).

Conclusion: The objective is to evaluate whether the bimodal therapy TRT and EMDR can

provide faster and/or more relief from the annoyance experienced in chronic tinnitus

patients’ daily lives compared to the bimodal therapy TRT and CBT.

So far there has been no prospective, randomized, controlled, clinical trial with blind

evaluator that compares CBT and EMDR as a treatment for tinnitus.

Trial registration: The present study protocol is registered on ClinicalTrials.gov:

NCT03114878

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3.1 INTRODUCTION

Tinnitus is defined as the perception of sound without the presence of an external auditory

input and therefore it is also referred to as a phantom percept (De Ridder, Elgoyhen et al.

2011). Usually tinnitus is transient, but 8 to 20% of the population suffers from chronic

tinnitus. About 1-3% of this population experiences so much distress that they seek

medical help (Baguley, McFerran et al. 2013). Tinnitus sounds reported by patients are

squeaking, buzzing or hissing sounds which can lead to a critical degree of psychological

discomfort and can have a serious impact on one’s quality of life. There is a high co-

morbidity found in patients suffering from a severe form of tinnitus, such as depression,

insomnia and anxiety (Langguth, Kreuzer et al. 2013). The diagnosis and treatment

therefore require a great expertise to detect the existing etiology and comorbidities. For

the treatment of complex tinnitus cases, a multidisciplinary approach by ENT-doctors,

specialized audiologists and psychologists is required (Shi, Robb et al. 2014, Van de

Heyning, Gilles et al. 2015).

Currently there is no pharmaco- or psychotherapeutic treatment that can alleviate chronic,

subjective tinnitus. Effective forms of therapy such as Tinnitus Retraining Therapy (TRT)

and Cognitive Behavioral Therapy (CBT) are intended to teach patients how to deal with

the tinnitus sound either through sound enrichment and psychoeducation or through the

alteration of cognitions. The clinical management for tinnitus of the last years consists of

audiologic interventions and cognitive behavioral therapy (Langguth, Kreuzer et al. 2013,

Tunkel, Bauer et al. 2014). A stepped care approach is recommended by guidelines that

147260 Luyten BNW.indd 97 22-12-2020 13:55 CHAPTER 3

start with education as first step and end with specialized multidisciplinary CBT as last step

(Cima, Maes et al. 2012). For a proportion of patients with tinnitus symptoms these

treatment forms lead to a significant reduction of distress. When the tinnitus, however,

causes a great interference with daily functioning, these treatment methods may not be

sufficiently effective (Cima, Maes et al. 2012).

Recent research showed that EMDR could be an effective therapy for medically

unexplained symptoms such as chronic pain and phantom pain (de Roos, Veenstra et al.

2010) (Van Rood and De Roos 2009), (Wilensky 2006, Iranshahr 2014, Rostaminejad,

Behnammoghadam et al. 2017). Francine Shapiro stated in 2001 that phantom pain can

be perceived as a manifestation of the stored somatic memory (Shapiro 2001). The

experiencing of pain while the limb is absent is an example of dysfunctional memory

storage. Through EMDR-treatment these somatic memory and pain sensations can be

targeted and restored. Therefore, we hypothesize that EMDR may also be an effective

treatment method for patients with subjective tinnitus.

Tinnitus is known as phantom sound and previous research has shown overlapping brain

networks between tinnitus and phantom pain (De Ridder, Elgoyhen et al. 2011). Multiple

dynamic brain networks such as the perception network, salience network, distress and

memory network play a major role in eliciting and maintaining this phantom perception

(Vanneste, Plazier et al. 2010, De Ridder, Elgoyhen et al. 2011, Vanneste and De Ridder

2012). Previous research showed that changes (i.e. neural plasticity) in the auditory system

elicited by a sound trauma could cause tinnitus. This neural plasticity is a reaction of the

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nervous system when there is a reorganization and hyperactivity in the auditory cortex

causing a tinnitus sensation (Kaltenbach and Afman 2000, Salvi, Wang et al. 2000).

Magnetoencephalography (MEG) and qEEG earlier showed that different neural networks

are at the basis of tinnitus loudness and tinnitus-related distress. Certain types of tinnitus

are related to the reorganization and hyperactivity of the auditory central nervous system

(Muhlnickel, Elbert et al. 1998, Kaltenbach, Zhang et al. 2000). Changes in neural activity

were also observed in non-auditory brain areas (Vanneste and De Ridder 2012). The

stress and emotional reactions associated with tinnitus probably find their neuronal

correlate in networks at the level of the amygdala, the hippocampus and anterior cingulate

cortex, the parahippocampus and the insula. Research shows that memory mechanisms

play an important role in the persistence of the awareness of the phantom percept.

Therefore these mechanisms are inextricably linked to the reinforcement of the associated

distress (De Ridder, Elgoyhen et al. 2011). In these regions neuronal changes occur.

We know that tinnitus is a phenomenon in which networks of auditory and non-auditory

brain areas influence each other (Andersson, Lyttkens et al. 2000, Mirz, Gjedde et al.

2000, Schlee, Hartmann et al. 2009, Vanneste, Plazier et al. 2010, De Ridder, Elgoyhen

et al. 2011). Hence tinnitus viewed from the perspective of a trauma, more specifically in

the auditory and limbic regions, leads to the need for effective information processing.

The development of new neural networks could be generated through EMDR: bilateral

stimulation promotes the plasticity of the brain causing neural networks to be adjusted.

Recent studies demonstrate increase in limbic processing along with decreased frontal

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activation as a consequence of bilateral stimulation. These patterns of neural activity could

facilitate the integration and reintegration of information (Herkt, Tumani et al. 2014,

Boukezzi, El Khoury-Malhame et al. 2017).

The use of bilateral stimuli to treat tinnitus is an innovative treatment method. In the literature

only limited data can be found in a few case studies where EMDR treatment is performed

on tinnitus patients (Plassmann 2009, Hochstenbach-Nederpel 2015). These scarce

data, however, provide insufficient insights concerning the EMDR treatment method and

the mechanisms. Therefore, a randomized-controlled study trial is necessary to examine

the effectiveness of EMDR in persons suffering from tinnitus.

3.1.1 Study Objectives

The present study is a prospective, randomized, controlled, clinical trial with blind evaluator

in order to assess whether EMDR adds value to the treatment in chronic tinnitus patients.

The general purpose of the current study is to examine a bimodal therapy for chronic,

subjective tinnitus consisting of the combination of the TRT and EMDR. The goal of this

treatment is reducing the subjective discomfort of tinnitus and thereby improving the quality

of life of the patient.

3.1.2 Study design

There will be 3 test moments during the trial: before the start of therapy (T0), after the

treatment sessions (T1) and 3 months after the last therapy session (T2). The primary and

secondary outcome measurements will be assessed at every test moment. The difference

100

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between bimodal therapy 1 (TRT + CBT) and bimodal therapy 2 (TRT + EMDR) will be

assessed. The experimental intervention, namely TRT + EMDR, will be compared to the

active control group, namely TRT + CBT, as shown in the Consolidated Standards of

Reporting Trails (CONSORT) flow diagram in Figure 3.1.

The SPIRIT checklist was utilized as guideline for this study.

Enrollment

Baseline: pre-intervention assessment (T0) Audiological intake

Psychological intake

Random assignment

Allocation

Allocated to intervention bimodal therapy 1 Allocated to intervention bimodal therapy 2 10 therapy sessions of 60 minutes over 12 10 therapy sessions of 60 minutes over 12 weeks weeks

Post-intervention

Post-intervention assessments (T1)

Follow-Up

3 month post-intervention assessments (T2)

FIGURE 3.1: CONSOLIDATED STANDARDS OF REPORTING TRIALS (CONSORT)

STUDY FLOW DIAGRAM. TRT TINNITUS RETRAINING THERAPY, CBT COGNITIVE

BEHAVIOURAL THERAPY, EMDR EYE MOVEMENT DESENSITIZATION

REPROCESSING

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3.1.3 Study population

Patients will be referred by the Ear, Nose and Throat (ENT) department of the Antwerp

University Hospital and will be randomized in group 1 (TRT + CBT) or group 2 (TRT +

EMDR). The allocation sequence will be determined by the date the patients are referred

to the study.

3.1.4 Inclusion and exclusion criteria

The appropriate ENT and audiological examinations will be performed in order to assess

whether a patient meets the inclusion criteria. During the study, the patient has the right to

cease the study at any time. The occurrence of severe adverse events can also lead to

discontinuation of the study.

The inclusion criteria are as follows:

• Tinnitus type: chronic, subjective, non - pulsatile tinnitus

• Duration of tinnitus = more than 3 months

• Minimum age of the patient is 18 years old – maximum age is 75 years old

• Tinnitus Functional Index (TFI) score ≥ 25 - < 90

• Stable use of medication during therapy

A patient is excluded from the study for the following reasons:

• HADS - score: anxiety and depression-subscores > 15

• HQ - score > 40

• Objective, pulsatile tinnitus

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• Active middle ear pathology

• Neurological and psychiatry co-morbidity for which acute psychotherapy is

ongoing

• Psychosis, schizophrenia, epilepsy

• Pregnancy

3.1.5 Study protocol

A number of 166 patients with subjective, chronic, non-pulsatile tinnitus will be randomized

in two treatment groups: TRT and CBT versus TRT and EMDR. Licensed therapists will

provide all treatments.

Tinnitus Retraining Therapy

TRT is a therapy originally developed by Prof. Pawel Jastrebroff and Dr. Jonathan Hazell

(Jastreboff and Jastreboff 2000). During the counseling, the patient is educated about the

working mechanism of tinnitus and how to deal with the emotional and physical responses.

The main goal is to habituate to the sound of the ringing in the ears. Every patient will

receive five 60-minute sessions of TRT. The TRT will consist of counseling, sound

enrichment and adjustment of a noise masker. A licensed tinnitus therapist will perform

the TRT-sessions using the patient counseling guideline of Henry et al. (Henry, Trune et

al. 2007).

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Cognitive Behavioral Therapy

CBT is the combination of behavioral therapy with interventions that have been developed

from cognitive psychology. The founders of CBT are Aaron Beck and Albert Ellis (Butler,

Chapman et al. 2006). The core idea is the assumption that so-called negative cognitions

are responsible for dysfunctional behavior. The techniques used in cognitive behavioral

therapy focus on changing the content of these irrational cognitions. The way tinnitus

influences our daily functioning is largely dependent on the meaning we give to this sound

and the thoughts we have associated with tinnitus determine which emotional reactions

are triggered.

Cognitive behavioral therapy helps the patient to change the thoughts associated with

tinnitus and as a consequence, alter the emotional response. Mindfulness and a number

of relaxation techniques were also developed within cognitive behavioral therapy. The

interventions are based on a 4-year postgraduate training in CBT and a tinnitus master

class by Dr. Aazh in 2013. Dr. Hashir Aazh BSc, MSc, PhD focuses on researching and

providing specialist therapy for patients experiencing tinnitus (Aazh, Moore et al. 2016).

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Following treatment outline will be the guideline for the CBT-sessions.

TABLE 4 Intervention based on the CBT treatment outline

Phase Number Treatment Outline

Phase 1 Educating the patient about the auditory system (brief, only if necessary after TRT- sessions)

Phase 2 Introduction of CBT and assess the motivation and commitment towards the therapy

Phase 3 Help identify thoughts, emotions and behavior in response to sound

Phase 4 Help identify negative automatic thoughts and core belief

Phase 5 Education about common errrors of judgement and distortions in thoughts

Phase 6 Challenging unhelpful thoughts and creating counterstatements

Phase 7 Empirical demonstration: experiencing the consequence of helpful thoughts

Phase 8 Behavioral desensitization and graded exposure

NOTE: CBT TREATMENT OUTLINE BY DR. AAZH BASED ON HANDOUTS AND

PERSONAL COMMUNICATION FROM THE TINNITUS & HYPERACUSIS MASTER

CLASS IN MARCH 2013 IN BIRKBECK COLLEGE, LONDON

Every patient that is randomized in the TRT + CBT – group will receive five 60-minute

sessions of CBT performed by a licensed clinical psychologist and psychotherapist

specialized in CBT.

Eye Movement Desensitization and Reprocessing

A licensed clinical psychologist will conduct the EMDR-sessions according to the original

protocol developed by Shapiro in 1987 (Shapiro 1999). This is a scientifically grounded,

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psychotherapeutic approach that represents a specific method within a wider theoretical

model called 'Adaptive Information Processing (AIP)' (Shapiro 1999). This term refers to

the innate capacity of the brain to process life experiences and incentives to achieve an

adaptive solution. The AIP-model states that the information processing system of the

brain can become obstructed as a result of psychological trauma and that specific

methods, such as EMDR, are a catalyst for effective information processing that leads to

a rapid and adaptive processing of the trauma (Solomon and Shapiro 2008).

Tinnitus can be interpreted as trauma at the level of the auditory regions of the brain. The

development of new neural networks where the tinnitus sound is processed as neutral

and non-threatening could be generated through EMDR. Eye movements, tactile

stimulation (buzzers) and auditory stimuli (headphone) can be used to facilitate the

activation of the left and right side of the brain. Within the treatment this is called bilateral

stimulation (Shapiro 1999, Schneider, Hofmann et al. 2007, Solomon and Shapiro 2008,

Iranshahr 2014).

The trauma-network is stimulated through a combination of standardized procedures that

include these repetitive eye-movements, auditory signals and tactile vibrations. To induce

the stimuli a validated EMDR-tool is used to help the clinician. The EyeScan 4000 will be

used in this study to guarantee continuity in the visual, auditory and tactile stimuli that are

used to stimulate bilateral activation. The original EMDR-protocol developed by Shapiro

will be followed in order to guarantee validity and test–retest reliability (Shapiro 2007).

The protocol contains eight phases. The first phase is the Client history in which the focus

lies on the tinnitus complaints. In this phase the negative thoughts and experiences will be

identified.

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In the second phase, the Preparation phase, stabilization techniques such as inducing a

‘safe place’ will be addressed. In the Assessment phase the clinician identifies the

components of the target being the tinnitus complaints. The negative belief, emotional and

physical sensations about the tinnitus will be made concrete. The patient will rate the

amount of distress using the 0-10 (0= neutral to 10 = the worst disturbance imaginable)

Subjective Units of Disturbance scale (SUDS) and the strength of the desired belief by

using the Validity of Cognition scale (VOC) with a range of 1-7 (1 = completely false to 7

= completely true). In the reprocessing phases, consisting of the Desensitization and

Installation phase and Body Scan, the bilateral stimulation will be used to activate the

traumatic network. During these phases the clinician will monitor how the patient is

processing information associated with the tinnitus.

In the last phases, the Closure and Reevaluation phase, the patient is brought to

equilibrium, and the distress level and positive treatment effects will be evaluated. Every

patient that is randomized in the TRT + EMDR – group will receive five 60 minute-sessions

of EMDR over 5 consecutive weeks.

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TABLE 5 Summary of the intervention based on the standard treatment EMDR protocol

by Shapiro (2001).

Phase Number

Phase 1 Client history Negative thoughts, feelings, sensations and experiences associated with the complaints will be identified. Phase 2 Preparation phase State stability of the client Secure a stop sign Installation of the calm/safe place Phase 3 Assessment phase Target issue, memory, event, or symptom Target image Negative cognition: NC Positive cognition: PC VoC (Validity of Cognition) Emotions SUDs (Subjective Units of Distress) Location of bodily sensation Phase 4 Desensitization phase “Bring the target image & negative cognition to mind, notice where you are feeling it in your body.” Set of bilateral stimuli (BLS) as fast as the client can tolerate After a set: “What do you get now?”, “What are you noticing?” If client reports new material: “Go with that.” Phase 5 Installation phase “Do the words PC still fit, or would another positive statement be more suitable?” Check VoC: “Think about the original incident and the words PC. How true do they feel now (1-7)?” “Bring the incident & positive cognition together in your mind”. Completion of sets of BLS until no change. Phase 6 Body scan The client will be asked to mentally scan the entire body and report the therapist what he / she can feel.

Phase 7 Closure The therapist will end the session by checking if the client feels calm. Gain of the session and reactions that can appear after the session will be discussed. Phase 8 Reevaluation The client gives an assessment of the results achieved in the follow-up session.

NOTE: SUMMARY BASED ON STANDARD PROTOCOL OF SHAPIRO, F. (2001). EYE

MOVEMENT DESENSITIZATION AND REPROCESSING. BASIC PRINCIPLES,

PROTOCOLS, AND PROCEDURES (2ND ED.). NEW YORK: GUILFORD PRESS

3.1.6 Side effects

There are no known side effects of TRT, CBT or EMDR. It is possible that some emotions

are triggered and temporarily elevated due to the processing of certain experiences.

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3.1.7 Ethics

Written consent will be obtained from every patient. The Ethical Committee of the Antwerp

University Hospital approved the study protocol on 17 October 2016 with protocol number

EC UZA 16/35/360.

3.2 ASSESSMENT MEASURES

Subjective and objective assessment measures will be used to assess the effectivity of

both interventions. Self-reported assessment measures and questionnaires provide us

with important subjective information. To date, tinnitus research is being challenged to

provide objective measures as well. By performing ERP-assessment we are able to collect

objective data. In Figure 3.2 we give an oversight of the enrolment, interventions and

assessment for the two bimodal therapies.

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Study period Enrollment Intervention Post-intervention Follow-up

Measurement time point T0 Baseline T1 (3-4 months after baseline) T2 (3 months after intervention)

Enrolment

Informed consent X

Intervention allocation X

Assessments

Tinnitus Functional Index X X X

Visual Analogue Scale of X X X loudness

Tinnitus Questionnaire X X X

Hospital Anxiety and X X X Depression Scale

Hyperacusis Questionnaire X X X

Psychoacoustic characteristics X X X of tinnitus

Audiologic measurements X X X

Event related potentials X X X

Intervention

Therapy sessions X

Follow-up counseling session X

FIGURE 3.2: STANDARD PROTOCOL ITEMS: RECOMMENDATIONS FOR

INTERVENTIONAL TRIALS (SPIRIT) GUIDELINE SCHEDULE OF ENROLMENT,

INTERVENTIONS AND ASSESSMENTS FOR BOTH INTERVENTION GROUPS

3.2.1 Primary outcome measurement

Tinnitus Functional Index (TFI)

The TFI is a self-reported questionnaire, consisting of 25 questions, which assesses the

impact of tinnitus on patients’ daily lives (Meikle, Henry et al. 2012, Rabau, Wouters et al.

2014). The patient answers each question on a Likert scale ranging from 0 to 10.

Questions 1 and 3 are expressed in percentages, and the Likert scale ranges from 0% to

100%. The total score is calculated with the mean of all questions. The answers are

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converted and the total score is expressed as a number between 0 and 100. In addition

to the total score, the score of eight subscales can be determined. The subscales are the

following: intrusiveness, reduced sense of control, cognitive interference, sleep

disturbance, auditory difficulties attributed to tinnitus, interference with relaxation, reduced

quality of life and emotional distress. A decrease in the score on the TFI in the TRT-CBT-

treatment group versus a decrease in the TFI-score in the TRT- EMDR-treatment group is

the primary focus of attention in this study.

3.2.2 Secondary outcome measurements

Visual Analogue Scale (VAS) of loudness

The patient scores the mean and maximum loudness of their tinnitus on a scale of 0

(absence of tinnitus) to 100 (as loud as possible, cannot be any louder).

Tinnitus questionnaire (TQ)

The TQ is a 52-item self-rating scale, which differentiates between dimensions of

emotional and cognitive distress, intrusiveness, auditory perceptual difficulties, sleep

disturbances and somatic complaints. The patient rates the items on a 3-point scale

(Goebel and Hiller 1994).

Hospital Anxiety and Depression Scale (HADS)

The HADS consists of 14 questions that assess anxiety and depression (Zigmond and

Snaith 1983, Spinhoven, Ormel et al. 1997). The patient can choose between four answer

options for each question. The score for both components is a summation of the scores

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of all the questions belonging to the subscale. A result greater than 8 suggests the

presence of a depression and/or anxiety disorder.

Hyperacusis Questionnaire (HQ)

The HQ is a 14-item questionnaire that surveys a patient’s hypersensitivity to sound

(Khalfa, Dubal et al. 2002). There are four answer options for every question: ‘no’, ‘yes a

little’, ‘yes quite a lot’ and ‘yes a lot’. A score of 28 is the cut-off for auditory hypersensitivity.

Psychoacoustic measurements

Psychoacoustic characteristics, such as frequency of tinnitus, loudness of tinnitus, and

residual inhibition will be determined.

The frequency of tinnitus will be determined by means of frequency matching for which a

forced choice technique is applied. The patient must choose between two presented

tones or noises until a tone or noise is found that is similar to the patient’s tinnitus. In case

of unilateral tinnitus, the contralateral ear is used as the test ear for frequency matching. In

case of bilateral tinnitus, the test ear can be chosen arbitrary. The loudness matching will

be performed by comparison of the tinnitus to a pure tone or noise in the ipsilateral ear.

Finally, the residual inhibition is the suppression of the patient’s tinnitus, measured by

presenting a narrowband noise, 15 dB HL louder compared to the tinnitus loudness, in

the ipsilateral ear. This procedure can (partially) mask the tinnitus, which is called a (partial)

positive result. When the tinnitus becomes louder, it is called rebound. However, some

patients do not notice any change.

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Audiologic measurements

Impedance measurements will be performed in order to exclude active middle ear

pathology, which is an exclusion criterion of the current study.

In order to categorize our patient group, all subjects will undergo an audiometric hearing

test according to current clinical standards (International Organization for Standardization

(ISO) 8253–1:2010) with a 2-channel Interacoustics AC 40 (Interacoustics A/S, Middelfart,

Denmark) in a soundproof audiometric booth. A TDH-39 headphone is used as transducer

to measure air conduction thresholds of frequencies ranging from 125 Hz to 16 kHz. Bone

conduction thresholds will be determined within a range of 250 Hz to 4 kHz.

In addition, Distortion Product Otoacoustic Emissions (DPOAEs) will be measured at

baseline using a pair of two pure tone frequencies (f1 and f2) closely spaced and

presented simultaneously at a level of 65 dB SPL for f1 and 55 dB SPL for f2 (frequency

ratio f2/f1 = 1,22). The largest and most robust distortion product is 2f1-f2 and can be

detected in almost all normal ears. The last conducted test is the speech-in-noise (SPIN)

test. The Leuven Intelligibility Sentence Test (LIST) (van Wieringen and Wouters 2008) will

be performed. An adaptive procedure is used with the noise at a fixed level of 65 dB SPL.

Initially the speech-to-noise ratio is equal to 0dB SNR, which implies that the noise and

the speech are presented equally loud. Subsequently, the intensity of the speech is varied

in steps of 2 dB adaptively in a 1-down (when the keywords in the sentence are repeated

correctly), 1-up (when the keywords in the sentence are repeated incorrectly) procedure

to determine the 50% correct identification point. This point is called the speech reception

threshold (SRT), expressed in dB SNR, and will be determined for each ear. A training list

for each ear will be conducted before starting the test.

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Event Related Potentials (ERP)

In this study, the emphasis is on the late auditory evoked potentials, which will be induced

by use of a classical oddball paradigm. As such, a standard tone of 1 kHz is repeated

with a probability of 80% randomly interrupted by an oddball (or infrequent) tone of 2 kHz

with a probability of 20%. This paradigm elicits late auditory evoked potentials comprising

of P1-N1-P2 and P300 of which the first complex is mostly generated by bottom-up

processes in the brain. The later P300 potential requires more top-down cognitive brain

processes and can be seen as an expression of higher cognitive sound processing in

tinnitus patients.

The hypothesis is that, given the continuous auditory processing of the tinnitus signal, the

brain may have less capacity left to align to other incoming stimuli, which may be altered

by therapy. The late auditory potentials will be measured prior to the therapy, after the

therapy and 3 months later.

3.3 STATISTICAL METHODS

Data will be analysed with SPSS statistical software version 20 (SPSS Inc., Chicago, IL,

USA). Descriptive analyses as means and standard deviations will be used to describe

the characteristics of the participants. Results of both intervention arms will be compared

using linear mixed models, accounting for the non-independence of observations within

the same individual by including random effect terms into the model. The outcome

measurements will be entered as dependent variables. In case this outcome variable

shows a non-normal distribution, the data will first be logarithmically transformed.

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Intervention group (TRT + CBT versus TRT + EMDR) and test moment (T0, T1, T2) are

entered as fixed effects. The significance level will be set at p < 0.05. The effect of bimodal

therapy 1 (TRT + CBT) vs. bimodal therapy 2 (TRT + EMDR) will be verified.

3.4 SAMPLE SIZE CALCULATION

A sample size calculation was carried out to determine the sample size required to obtain

a power of 80% with α = 0.05 in a two-sided two-sample t-test. Assuming an average

difference of 0.7 SD between both treatment groups – simplifying the calculation by

considering the change in outcome between the first and the last point – a power of 80%

is reached with minimal sample size of 65 patients per treatment group. To cover possible

drop out, 166 patients will be randomized between therapy group TRT + CBT and therapy

group TRT + EMDR. The CONSORT – guidelines will be followed and the enrolment data

will be transferred into the flow diagram.

3.5 DISSEMINATION PROTOCOL

According to the Standard Protocol Items: Recommendations for Interventional Trials

(SPIRIT) guidelines, the authors declare that data that break the blind will not be presented

prior to release of mainline results. Breaking of the blind will occur at the end of the study.

A clinical article will be written on the primary and secondary outcomes of the study and

will be disseminated regardless of the magnitude or direction of effect. The present trial is

not industry initiated; therefore, there is no publication restriction imposed by sponsors. In

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addition, a full study report anonymized participant-level dataset and statistical code for

generating the results will be made publicly available no later than 3 years after termination

of the study for sharing purposes.

3.6 DISCUSSION

Currently there is no medical or psychotherapeutic treatment that can alleviate chronic,

subjective tinnitus. Tinnitus sufferers often hear that they will have to learn to live with this

condition. However, for a significant amount of the population the tinnitus causes a severe

interference with daily functioning and present treatment methods may not provide

sufficient relief for these specific patients. For patients experiencing a great decrease in

their quality of life, EMDR could be an important therapy since it has shown to be effective

in the treatment of medically unexplained symptoms such as chronic pain and phantom

pain. Seeing the fact that tinnitus is described as a phantom percept, we suggest that

EMDR may be of significant value in treating patients with subjective, chronic tinnitus.

The main objective is to evaluate whether the bimodal therapy TRT and EMDR can provide

faster and/or more relief from the annoyance caused by the tinnitus sound compared to

the bimodal therapy TRT and CBT. So far there is no clinical trial that uses this combination

of methods as a treatment for tinnitus. Furthermore, we believe this is the first research

project that will analyse subjective and objective parameters as outcome measurements

in bimodal therapy in the treatment of tinnitus.

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147260 Luyten BNW.indd 118 22-12-2020 13:55

CHAPTER FOUR BIMODAL THERAPY FOR BIMODAL THERAPY FOR CHRONIC SUBJECTIVE TINNITUS: ACHRONIC RANDOMIZED SUBJECTIVE CONTROLLED TRIALTINNITUS: OF EMDR AND TRT 4 A RANDOMIZED CONTROLLED VERSUS CBT AND TRT TRIAL OF EMDR AND TRT

VERSUS CBT AND TRT

Published in Frontiers in Psychology 4

Luyten, T. & Jacquemin, L., Van Looveren, N., Cardon,Luyte E.,n, T.Fransen, & Jacquemi E., Declau,n, L., Van F., Loovere De Bodt,n, N. M.,, Cardon, E., Fransen, E., Declau, Topsakal, V., Van de Heyning, P., Van Rompaey, V., F., De Bodt, M., Topsakal, V., Van de Heyning, P., Van Rompaey, V., & Gilles, & Gilles, A. A. 2020. Frontiers in Psychology, 11, 2048.

Published in Frontiers in Psychology Bimodal therapy for chronic subjective tinnitus: a randomized controlled trial of EMDR and TRT versus CBT and TRT. Frontiers in Psychology, 11, 2048, 2020. Chapter Chapter

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4. BIMODAL THERAPY FOR CHRONIC SUBJECTIVE

TINNITUS: A RANDOMIZED CONTROLLED TRIAL OF

EMDR AND TRT VERSUS CBT AND TRT

ABSTRACT

Introduction: To date, guidelines recommend the use of a stepped care approach to treat

tinnitus. The current clinical management of tinnitus frequently consists of audiologic

interventions and Tinnitus Retraining Therapy (TRT) or Cognitive Behavioral Therapy (CBT).

Due to the high heterogeneity of the tinnitus population and comorbidity of tinnitus with

insomnia, anxiety and depression, these interventions may not be sufficient for every

patient. The current study aims to determine whether a bimodal therapy for chronic,

subjective tinnitus consisting of the combination of TRT and Eye Movement Desensitization

Reprocessing (EMDR) results in a clinically significant different efficacy in comparison with

the prevailing bimodal TRT and CBT therapy.

Methods / design: Patients were randomized in two treatment groups. The experimental

group received the bimodal therapy TRT / EMDR and the active control group received

the bimodal therapy TRT / CBT. Evaluations took place at baseline (T0), at the end of the

treatment (T1) and 3 months after therapy (T2). The Tinnitus Functional Index (TFI) was used

as primary outcome measurement. Secondary outcome measurements were the Visual

Analogue Scale of tinnitus loudness (VASLoudness), Tinnitus Questionnaire (TQ), Hospital

Anxiety and Depression Scale (HADS), Hyperacusis Questionnaire (HQ), Global Perceived

Effect (GPE), and psychoacoustic measurements.

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Results: The TFI showed clinically significant improvement in both bimodal therapies (mean

decrease 15.1 in TRT / CBT; p < .001 vs. 16.2 in TRT / EMDR; p < .001). The total score

on the TQ, HADS, HQ, and VASLoudness all demonstrated significant decrease after

treatment and follow-up (p < .001) in the experimental and the active control group. GPE-

measurements revealed that more than 80% (i.e. 84% in TRT/CBT vs. 81% in TRT/EMDR)

of the patients experienced substantial improvement of tinnitus at follow up. Treatment

outcome remained stable after three-month follow-up and no adverse events were

observed.

Conclusion: Both psychotherapeutic protocols result in a clinically significant improvement

for patients with chronic subjective tinnitus. No significant different efficacy was found for

the TRT/EMDR treatment compared to the combination of TRT and CBT.

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4.1 INTRODUCTION

Tinnitus, the perception of sound in the absence of an external sound source, also known

as phantom percept (Baguley, McFerran et al. 2013), can be extremely bothersome.

About 8 to 20% of the population report chronic tinnitus and for 1 to 3% of these patients

the sound is so debilitating that professional help is necessitated (Heller 2003). Tinnitus

can be experienced as stressful, irritating, frightening, alarming and can have a huge

impact on quality of life. Recent findings show high comorbidity with psychological and

psychosomatic symptoms and/or psychiatric syndromes such as anxiety disorders,

insomnia, and depression (Eysel-Gosepath and Selivanova 2005, Malakouti,

Mahmoudian et al. 2011, Geocze, Mucci et al. 2013, Pinto, Marcelos et al. 2014, Pattyn,

Van Den Eede et al. 2016). The tinnitus population is highly heterogeneous, often requiring

a combination of therapeutic support to manage the complexity of the symptoms. Hence,

a specialized and client-centered treatment plan executed by a multidisciplinary team of

professionals is recommended (Van de Heyning, Gilles et al. 2015).

Clinical management with the integration of audiological and psychological interventions

such as Tinnitus Retraining Therapy (TRT) and Cognitive Behavioral Therapy (CBT) is

regularly introduced (Langguth, Kreuzer et al. 2013, Shi, Robb et al. 2014). TRT

management consists of reassurance, education, and use of sound enrichment through

hearing aids or sound generators in order to reduce the tinnitus percept. Caregivers often

use some form of TRT (Phillips and McFerran 2010) or offer counseling based on the

neurophysiological model of Jastreboff (Jastreboff and Jastreboff 2000, Jastreboff 2007).

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CBT as a treatment for tinnitus focusses on modifying dysfunctional thoughts and coping

strategies in order to change the emotional reactions towards the tinnitus sound (Martinez‐

Devesa, Waddell et al. 2007, Hesser, Weise et al. 2011). TRT and CBT may lead to

habituation of the tinnitus sound, helpful thoughts, and adapted reactions towards the

sound. Different treatment protocols were developed ranging from an intensive CBT-

approach (Aazh, Moore et al. 2016, Aazh and Moore 2018) to a stepped-care-approach

(Cima, Maes et al. 2012, Cima, Andersson et al. 2014). To date, the European guidelines

strongly recommend CBT to treat tinnitus (Cima, Mazurek et al. 2019). Nevertheless, in

some cases extensive CBT and/or TRT programs do not render sufficient tinnitus relief for

patients, thus additional therapies may be required.

Chronic, subjective tinnitus is considered a medically unexplained symptom as, to date,

there is no consensus concerning the underlying pathophysiology (Hiller, Janca et al.

1997, Hiller, Goebel et al. 1999). Eye Movement Desensitization Reprocessing (EMDR)

has proven to be a highly effective treatment for medically unexplained symptoms

(Wilensky 2006, Van Rood and De Roos 2009, de Roos, Veenstra et al. 2010, Iranshahr

2014, Rostaminejad, Behnammoghadam et al. 2017) such as chronic pain, chronic

headache, and chronic fatigue syndrome.

The mechanisms that underpin EMDR are not yet fully understood. This well-structured

psychotherapeutic method is based on the theoretical model called ‘Adaptive Information

Processing (AIP)’ (Shapiro 2001, Solomon and Shapiro 2008). AIP is the capacity of the

human brain to process experiences to develop an adaptive solution for the context one

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is living in. Trauma can obstruct this natural information processing system and therefore

specific methods are necessary to facilitate this innate ability to adapt (Shapiro 2007). At

the level of the auditory regions of the brain, tinnitus can be perceived as trauma. The

emotional reactions associated with the tinnitus sound trigger networks at the level of the

insula, hippocampus, parahippocampus, anterior cingulate cortex and the amygdala. A

tangle of auditory and non-auditory networks influence each other when tinnitus becomes

persistent and chronic (Mirz, Gjedde et al. 2000, Schlee, Hartmann et al. 2009, Vanneste,

Plazier et al. 2010, De Ridder, Elgoyhen et al. 2011). There is a need to understand the

relationship between EMDR as a possible facilitator and the processing of tinnitus.

Previous research has shown that the bilateral stimulation used in EMDR increases limbic

processing together with decreasing frontal activation. Integration and reintegration of

information about the tinnitus could therefore be facilitated through these patterns of neural

activity. New adaptive reactions to the tinnitus sound could lead to new neural networks

causing the tinnitus sound to be processed as a non-threatening and neutral sound (Herkt,

Tumani et al. 2014, Boukezzi, El Khoury-Malhame et al. 2017).

Few studies have reported the use of EMDR as a treatment method for tinnitus (Zengin

2009, Hochstenbach-Nederpel 2015, Rikkert, Van Rood et al. 2018, Phillips, Erskine et

al. 2019), but outcomes remain unclear. Although some research has been carried out

on EMDR and tinnitus, only two studies have attempted to investigate the efficacy

systematically. Rikkert et al. (2018) conducted a pilot study showing promising results in

treating 35 participants with high levels of chronic tinnitus distress with EMDR. Compared

to the waiting list condition, scores on the Tinnitus Functional Index (TFI), Mini-Tinnitus

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Questionnaire (Mini-TQ), and Symptom Checklist-90 (SCL-90) decreased significantly in for 5 consecutive weeks and received a 60 – minute follow-up session 3 months after the

the treatment group (Rikkert, Van Rood et al. 2018). A recent pilot study with a sample last psychotherapy session. Because of the intensive therapy trajectory patients were

size of 14 participants was published, reporting a decrease of more than 20 points on the followed up closely from the inclusion until 9 months later. Figure 4.1 displays the study

Tinnitus Handicap Inventory (THI) after EMDR treatment (Phillips, Erskine et al. 2019). design that was applied.

However, the effects of EMDR therapy in tinnitus remain elusive and further research is All patients signed an informed consent form prior to enrollment. The Ethical Committee of required (Luyten, Van Rompaey et al. 2020). the Antwerp University Hospital approved the study protocol on 17 October 2016 with This prospective study was designed to examine the effect of EMDR as possible protocol number EC UZA 16/35/360. This study is registered at ClinicalTrials.gov, number psychotherapeutic treatment for chronic, subjective tinnitus. A randomized controlled trial NCT03114878. was set up to investigate (1) whether a bimodal therapy containing of a therapy protocol

of TRT and EMDR results in a clinically significant different efficacy compared to the

standard treatment combining TRT and CBT and (2) to evaluate the effect of the bimodal

treatments on the primary and secondary outcome measurements. To our knowledge,

this is the first RCT that explores both therapeutic interventions simultaneously.

4.2 MATERIALS AND METHODS

4.2.1 Study design FIGURE 4.1: STUDY DESIGN. A TOTAL OF 89 PARTICIPANTS WERE DIVIDED INTO TWO TREATMENT GROUPS: TRT/CBT (N = 43) OR TRT/EMDR (N = 46). EACH This prospective, randomized, controlled clinical trial with blind evaluator was conducted GROUP RECEIVED 5 SESSIONS OF TRT AND 5 SESSIONS OF EITHER CBT OR at the University Hospital of Antwerp and the multidisciplinary private practice Hoorzorg EMDR, WITH ONE SESSION EACH WEEK. PSYCHOACOUSTIC MEASUREMENTS

Van Looveren in Borsbeek, Belgium. All participants were randomized in one of the two AND QUESTIONNAIRES WERE PART OF THE ASSESSMENT PERFORMED AT PRE-

THERAPY (T0), POST-THERAPY (T1), AND FOLLOW-UP (T2). (CBT, COGNITIVE treatment groups: one group received a combination of TRT and CBT while the other BEHAVIORAL THERAPY; EMDR, EYE MOVEMENT DESENSITIZATION AND group received a combination of TRT and EMDR. Patients were given 60 – minute TRT REPROCESSING; TRT, TINNITUS RETRAINING THERAPY).

sessions for 5 consecutive weeks, 60 – minute psychotherapy sessions (CBT or EMDR)

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for 5 consecutivefor 5 consecutive weeks weeks and received and received a 60 – a minute 60 – minute follow -followup session-up session 3 months 3 months after the after the

last psychotherapylast psychotherapy session. session. Because Because of the of intensive the intensive therapy therapy trajectory trajectory patients patients were were

followedfollowed up closely up closely from thefrom inclusion the inclusion until 9 until months 9 months later. Figurelater. Figure 4.1 dis 4.1plays dis playsthe study the study

designdesign that was that applied. was applied.

All patientsAll patients signed signed an informed an informed consent consent form prior form to prior enrollment. to enrollment. The Ethical The Ethical Committee Committee of of

the Antwerpthe Antwerp University University Hospital Hospital approved approved the study the studyprotocol protocol on 17 on October 17 October 2016 2016with with

protocolprotocol number number EC UZA EC 16/35/360. UZA 16/35/360. This s Thitudys sistudy registered is registered at ClinicalTrials.gov, at ClinicalTrials.gov, number number

NCT03114878NCT03114878. .

FIGUREFIGURE 4.1: STUDY 4.1: STUDY DESIGN. DESIGN. A TOTAL A TOTAL OF 89 OF PARTICIPANTS 89 PARTICIPANTS WERE WERE DIVIDED DIVIDED INTO INTO TWO TWOTREATMENT TREATMENT GROUPS: GROUPS: TRT/CBT TRT/CBT (N = 43) (N =OR 43) TRT/EMDR OR TRT/EMDR (N = 46). (N = EACH 46). EACH GROUPGROUP RECEIVED RECEIVED 5 SESSIONS 5 SESSIONS OF TRT OF AND TRT 5AND SESSIONS 5 SESSIONS OF EITH OFER EITH CBTER ORCBT OR EMDR,EMDR, WITH WITHONE SESSIONONE SESSION EACH EACH WEEK. WEE PSYCHOACOUSTICK. PSYCHOACOUSTIC MEASUREMENTS MEASUREMENTS AND QUESTIONNAIRESAND QUESTIONNAIRES WERE WERE PART PARTOF THE OF ASSESSMENT THE ASSESSMENT PERFORMED PERFORMED AT PRE AT- PRE-

THERAPYTHERAPY (T0), POST (T0), POST-THERAPY-THERAPY (T1), AND (T1), FOLLOWAND FOLLOW-UP (T-2UP). (CBT, (T2). (CBT,COGNITIVE COGNITIVE BEHAVIORALBEHAVIORAL THERAPY; THERAPY; EMDR, EMDR, EYE MOVEMENT EYE MOVEMENT DESENSITIZAT DESENSITIZATION ANDION AND REPROCESSING;REPROCESSING; TRT, TINNITUSTRT, TINNITUS RETRA RETRAININGINING THERAPY). THERAPY).

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4.2.2 Randomization and masking

Patients were referred by the Ear, Nose, and Throat (ENT) department of the Antwerp

University Hospital and were randomized in the active control group (TRT / CBT) or the

experimental group (TRT / EMDR) by use of a stratification paradigm according to TFI

grade (exclusion of grade 1). The allocation sequence was determined by the date that

patients were referred to the study. Patients were masked to the treatment group

allocation. Participants were not aware of the alternative treatment to prevent bias and

influencing the motivation of the patients. The investigators, as well as the TRT-therapist,

were also masked to the treatment group. The psychotherapist who conducted the CBT

and the EMDR treatment was not blinded and informed the participants about the study

protocol.

4.2.3 Participants

Patients aged 18 to 75 years old with chronic, subjective, non-pulsatile tinnitus ( > 3

months) were eligible for inclusion. A score of 25 or more, but no higher than 90, on the

TFI and stable use of medication during the study was considered necessary to take part.

An anxiety and depression subscale score on the Hospital Anxiety and Depression Scale

(HADS) of more than 15 and a score of more than 40 on the Hyperacusis Questionnaire

(HQ) were used as cut-off scores for a referral to other treatments. The diagnosis of an

objective, pulsatile tinnitus, an active middle ear pathology, neurological and psychiatric

co-morbidity for which acute psychotherapy was ongoing, psychosis, schizophrenia,

epilepsy, or pregnancy also led to exclusion of the study. From October 2016 to April

2019 137 patients were randomized from a total of 166 patients who were screened at

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the University Hospital of Antwerp. A total of 91 patients started the treatment and 89

patients completed the therapeutic trajectory. Figure 4.2 shows the trial profile, including

the reasons for exclusion and drop-out. Only two patients discontinued treatment because

of intrusive reasons, more specifically one patient was admitted to a psychiatric facility for

complaints other than tinnitus and one patient did not respect the treatment protocol by

initiating other treatments (i.e. neuromodulation, medication, and infiltration).

FIGURE 4.2: CONSORT FLOW DIAGRAM. TRIAL PROFILE OF THE 166 PATIENTS WHO WERE SCREENED FOR ELIGIBILITY. A TOTAL OF 89 PATIENTS COMPLETED THE STUDY. (TRT, TINNITUS RETRAINING THERAPY; CBT, COGNITIVE BEHAVIORAL THERAPY; EMDR, EYE MOVEMENT DESENSITIZATION AND REPROCESSING; HADS, HOSPITAL ANXIETY AND DEPRESSION SCALE).

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The baseline characteristics of the participants are presented in Table 6. The audiometric

baseline evaluation consisted of pure tone audiometry and tympanometry. The pure tone

audiometry was conducted using a two-channel Interacoustics AC-40 audiometer

(Interacoustics A/S, Middelfart, Denmark) in a sound-treated booth. Air conduction

thresholds were determined using a TDH-39 headphone at frequencies from 125 Hz to

16 kHz (International Organization for Standardization (ISO) 8253–1, 2010). In addition,

active middle ear pathology could be excluded by performing tympanometry. The two

groups (i.e. TRT/EMDR vs. TRT/CBT) did not differ significantly in these baseline

characteristics (p > .05).

TABLE 6 Baseline characteristics

Characteristics Total TRT/EMDR TRT/CBT Number of subjects 89 46 43

Age 47.87 (12.67) 47.52 (12.25) 48.23 (13.39)

Sex

§ Male 63 (70.8%) 30 (65.2%) 33 (76.7%)

§ Female 26 (29.2%) 16 (34.8%) 10 (23.3%)

Mean duration of tinnitus 7 years (8.66) 7 years (7.68) 8 years (9.66)

Tinnitus sound

§ Pure tone 56 (62.9%) 29 (63%) 27 (62.8%)

§ Noise 22 (24.7%) 11 (23.9%) 11 (25.6%)

§ Polyphonic 11 (12.4) 6 (13%) 5 (11.6%)

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Characteristics Total TRT/EMDR TRT/CBT Tinnitus side

§ Left 21 (23.6%) 10 (21.7%) 11 (25.6%)

§ Right 7 (7.9%) 5 (10.9%) 2 (4.7%)

§ Bilateral 39 (43.8%) 18 (39.1) 21 (48.8%)

§ Central 22 (24.7%) 13 (28.3%) 9 (20.9%)

PTA left ear 18.22 (17.01) 16.93 (16.51) 19.17 (17.60)

PTA right ear 15.50 (14.06) 15.37 (14.36) 15.54 (13.57)

TFI 51.81 (20.18) 53.88 (18.40) 49.60 (21.93)

TQ 40.40 (16.04) 39.65 (15.19) 41.21 (17.04)

HQ 22.72 (8.13) 22.98 (7.29) 22.44 (9.02)

HADS

§ Anxiety 9.44 (4.31) 9.39 (4.11) 9.49 (4.57)

§ Depression 7.40 (4.20) 7.54 (4.38) 7.26 (4.03)

VASLoudness 60.03 (22.68) 60.49 (23.90) 59.55 (21.57)

DATA ARE MEAN (SD) OR N (%), SD: STANDARD DEVIATION, PTA: PURE TONE AVERAGE FOR 1KHZ, 2 KHZ, AND 4 KHZ, TFI: TINNITUS FUNCTIONAL INDEX, TQ: TINNITUS QUESTIONNAIRE, HQ: HYPERACUSIS QUESTIONNAIRE, HADS: HOSPITAL

ANXIETY AND DEPRESSION SCALE, VASLOUDNESS: VISUAL ANALOGUE SCALE FOR TINNITUS LOUDNESS

4.2.4 Procedures

Licensed therapists carried out all treatments. One certified therapist performed the

modified TRT protocol. Another certified psychotherapist conducted the EMDR and CBT

to exclude the bias of the therapist effect. The variable of location could also be controlled

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by conducting all the therapy sessions in the private practice. All patients received the

same amount of contact hours during the treatment. After an initial audiological intake at

the University Hospital of Antwerp, patients were referred to the psychotherapist for the

screening interview. During this intake session the patient history, complaints associated

with the tinnitus, possible comorbidities, important life events, motivation, and availability

were queried. After this interview patients were randomized in one of the two bimodal

therapies: TRT/CBT or TRT/EMDR. The complete study protocol is described in Luyten et

al. (2019).

Tinnitus Retraining Therapy

Both bimodal therapies were designed with the inclusion of TRT as a large amount of the

referred patients received some form of education about the auditory system and the use

of sound enrichment before entering the study. To ensure that all patients started from the

same level of psychoeducation, we chose to implement TRT as this educational-based

treatment consists of a protocollary approach feasible to replicate by therapists enhancing

validity and reliability and the proven effectivity of the treatment (Jastreboff 2007, Grewal,

Spielmann et al. 2014, Van de Heyning, Gilles et al. 2015). The general principles and

methodology described by Prof. Pawel Jastreboff and Dr. Jonathan Hazell were carried

out (Jastreboff and Jastreboff 2000, Jastreboff 2007). This tinnitus-specific educational

counseling focusses on how to deal with the emotional and physical responses of tinnitus.

The patient counseling guideline of Henry, Trune et al. (2007) was used to help the patient

habituate to the bothersome sound. The main focus and content of TRT were respected.

The components that were highlighted are shown in Appendix B.

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Cognitive Behavioral Therapy

Originally CBT is based on the assumption that thoughts influence emotions and behaviors

(Butler, Chapman et al. 2006, Wright 2006). Thus, if thoughts about the tinnitus change,

the emotional and behavioral response can change as a consequence. During therapy,

the main focus was cognitive restructuring, the perception of the tinnitus and the

experiences of the patient. The CBT that was implemented was conducted by a certified

psychotherapist. Supervision was organized by a registered CBT-therapist. Appendix B

demonstrates the content of the CBT-sessions.

Eye Movement Desensitization and Reprocessing

EMDR was developed by Francine Shapiro in 1987. This psychotherapeutic method

consists of an eight-phase protocol. This protocol was respected as the therapeutic

sessions were conducted following the guidelines created by Shapiro (Shapiro 2001).

Bilateral stimulation was utilized to activate the left and right hemisphere during the

desensitization phase and induce taxing of the working memory. All patients started with

the alternating visual stimuli as this form of stimulation tends to provide the best evidence

for effectiveness (Maxfield 2008, van den Hout, Engelhard et al. 2011). In some cases,

the tactile stimuli were induced and only one patient tried the headphones elicitating

auditive side to side stimuli. The Eyescan 4000 was employed to generate the eye

movements, and tactile or auditory stimuli to activate the left and right side of the brain

(Shapiro 2007). The use of this device was chosen to create the opportunity to count and

compare the total number of stimuli used and to guarantee test-retest reliability. The

psychotherapist was a licensed clinical psychologist, a Europe Practitioner in EMDR and

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received supervision from a registered EMDR supervisor. The combination of standardized

procedures performed during bimodal therapy 2 is summarized in Appendix C.

4.2.5 Outcomes

4.2.5.1 Primary Outcome Measurement

Tinnitus Functional Index

All measurements were assessed at baseline before therapy (T0), within one week after

therapy (T1) and 3 months after the last therapy session (T2). The primary outcome was

the Tinnitus Functional Index (TFI). The 8 main domains that can be affected by tinnitus

(intrusiveness, reduced sense of control, cognitive interference, sleep disturbance,

auditory difficulties attributed to tinnitus, interference with relaxation, reduced quality of life

and emotional distress) were investigated through this questionnaire. This self-reported

questionnaire consists of 25 questions with Likert scale ranges from 0-100. A score under

25 is perceived as a mild complaint, scores between 25 and 50 as clinical significant

complaints that need treatment and scores higher than 50 require intensive specialized

treatment (Meikle, Henry et al. 2012, Rabau, Wouters et al. 2014). A reduction of 13 points

is considered a clinically significant reduction of tinnitus distress, tinnitus severity and the

impact of tinnitus on the quality of life (Meikle, Henry et al. 2012).

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4.2.5.2 Secondary Outcome Measurements

Visual Analogue Scale of Tinnitus Loudness

Secondary outcomes included questionnaire measures. The mean and maximum

loudness of the tinnitus during the day were scored on a Visual Analogue Scale of tinnitus

loudness (VASLoudness), scaled from 0 (absence of tinnitus) to 100 (as loud as possible).

Patients indicate the average loudness on a horizontal line. The left end indicating ‘no

tinnitus’ and the right end indicating ‘as loud as you can imagine’ (Adamchic, Langguth et

al. 2012).

Tinnitus Questionnaire

In the Tinnitus Questionnaire (TQ) the tinnitus related distress is rated on 52 items. The

questions are answered on a 3-point scale ranging from 0 (‘true’), 1 (‘partly true’) to 2 (‘not

true’). Emotional and cognitive distress, intrusiveness, auditory perceptual difficulties, sleep

disturbances, and somatic complaints were scored. The total score divides patients in

four categories: mild complaints (up to 30 points), moderate complaints (31 – 46 points),

severe complaints (47 – 59 points), and very severe complaints (60 – 84 points) (Hallam,

Jakes et al. 1988, Meeus, Blaivie et al. 2007, Hallam 2008).

Hospital Anxiety and Depression Scale

To screen for the presence of signs of depression and/or anxiety the Hospital Anxiety and

Depression Scale (HADS) was used (Zigmond and Snaith 1983, Wilkinson and Barczak

1988, Spinhoven, Ormel et al. 1997). This 14-item questionnaire makes use of 4 answer

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options for each question. The summation of the subscales gives a signal for the possible

occurrence of depression or anxiety in need for specific treatment. A score between 8

and 10 on a subscale indicates ‘borderline’ psychological morbidity and a score of more

than 10 indicates a significant ‘case’ of anxiety or depression.

Hyperacusis Questionnaire

The Hyperacusis Questionnaire (HQ) surveyed the hypersensitivity to sound by use of 14

self-rating items with a four-point answer scale (‘no’ scoring 0, ‘yes, a little’ scoring 1, yes,

quite a lot’ scoring 2, and ‘yes, a lot’ scoring 3 points). A score of 28 is used as the cut-

off for auditive hypersensitivity. (Khalfa, Dubal et al. 2002, Meeus, Spaepen et al. 2010,

Fackrell, Fearnley et al. 2015). However recent research proposed a cut-off HQ score of

16 for classifying hyperacusis (Oishi, Yamada et al. 2017).

Global Perceived Effect

The Global Perceived Effect (GPE) scale was used to investigate the sense of

improvement each patient experienced after treatment. Ratings consisted of a seven-point

transition scale and indicated the subjective opinion on the improvement or deterioration

since the start of the treatment (Hudak and Wright 2000, Kamper, Ostelo et al. 2010).

Tinnitus complaints were rated from -3 (much worsened), -2 (worsened), -1 (slightly

worsened), 0 (not changed), 1 (slightly improved), 2 (much improved) to 3 (a lot improved).

Psychoacoustic tinnitus analysis was conducted at T0, T1, and T2, consisting of pitch

matching, loudness matching, and residual inhibition testing. The tinnitus pitch was

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determined by means of a forced-choice technique. The patient was asked to choose

between two presented pure tones or small band noises (depending on the type of

tinnitus) in order to find the best possible match. The stimuli were presented in the

contralateral ear. In the case of central tinnitus, the test ear was chosen arbitrarily. The

tinnitus loudness matching was performed by comparing the patient’s tinnitus to a pure

tone or small band noise of the matched frequency in the ipsilateral ear. The loudness

could be changed with an accuracy of 1 dB HL. The intensity of the matched sound is

expressed in dB HL and dB SL, with the reference level of dB being the average hearing

threshold of a normal-hearing listener and patient’s threshold respectively. The residual

inhibition is the ability of a sound to suppress the patient’s tinnitus, which is measured by

presenting a narrow band noise in the ipsilateral ear at an intensity 15 dB louder compared

to the matched loudness for one minute. This test results in no change, partial

suppression, total suppression, or tinnitus increase (i.e. rebound).

4.2.6 Statistical analysis

The current study aimed to (1) assess whether a bimodal therapy for chronic subjective

tinnitus consisting of the combination of TRT and EMDR results in a clinically significant

different efficacy in comparison with the prevailing bimodal TRT and CBT therapy, and (2)

evaluate the effect of the bimodal treatment on the primary (i.e. TFI) and secondary

outcome measurements.

Data were analyzed using SPSS statistical software version 25 (SPSS Inc., Chicago, IL,

USA). There were three repeated measurements for each individual. To test the first

research question, a linear mixed model was constructed, with the treatment group as

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fixed effect and the interaction between treatment group and time added to the model.

The second research question was investigated using a similar linear mixed model, which

included time as fixed effect and a random intercept, accounting for the nonindependence

between the observations taken from the same individual. If the effect of time was

significant, a post hoc analysis with Bonferroni correction for multiple testing was

conducted.

The analyses were carried out using linear mixed model analysis, which is robust against

data missing at random. To assess the goodness of fit for the mixed models, we carried

out a Levene’s Test for equality of variances. In addition, homoscedasticity was visually

inspected using boxplots.

4.3 RESULTS

This randomized controlled trial was conducted aiming to investigate the effect of bimodal

treatment TRT/EMDR compared to the effect of bimodal treatment TRT/CBT on the tinnitus

outcome measurements. All means and standard deviations at T0, T1, and T2 are shown

in Table 7. The estimated group differences, p values and effect sizes for primary and

secondary outcomes are compared in Table 8.

The change on the TFI total score over time was statistically significant in both bimodal

therapies (p < .001), with a mean improvement of 15.7 points from T0 to T2 (respectively a

mean decrease of 15.1 in TRT / CBT; p < .001 vs. 16.2 in TRT / EMDR; p < .001). This

effect was not significantly different between the two treatment groups (p > .05). Post-hoc

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analysis showed no significant changes between T1 and T2. In other words, the level of

improvement remained stable after 3 months subsequent to completion of the therapy

(Fig 4.3).

FIGURE 4.3: TOTAL TFI SCORES BY THERAPY GROUP AND TIME PERIOD. ERROR

BARS REPRESENTING 95% CI INTERVAL.

Figure 4.4 depicts an overview of all TFI – subscales. Clinically significant improvement

was reached on every subscale in both treatment groups, except for the subscale Sleep

Disturbances after TRT/CBT and the subscale Auditory Difficulties after TRT/CBT and

TRT/EMDR.

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25,00

20,00

15,00

10,00 Mean TFI decrease at follow up follow at Mean decrease TFI 5,00

0,00 Sense of Cognitive Sleep Auditory Quality Of Emotional Total Intrusiveness Relaxation Control Interference Disturbance Difficulties Life Distress EMDR 16,17 15,58 19,93 14,28 14,35 9,49 21,16 15,54 19,20 CBT 15,11 18,76 16,98 16,05 10,93 5,97 18,14 15,00 19,07

FIGURE 4.4: OVERVIEW OF MEAN DECREASE AT FOLLOW UP ON ALL TFI

SUBSCALES FOR BOTH TREATMENT GROUPS INDICATING THE CUT-OFF OF A

DECREASE OF 13 POINTS AS MARKER FOR CLINICALLY SIGNIFICANT

IMPROVEMENT (CSI).

With regards to the secondary outcomes, the TQ total score (Fig 4.5), HADS anxiety score,

HADS depression score, HQ score, and VAS of tinnitus loudness also improved

significantly over the three visits (p < .001) (Fig 4.6). The tinnitus frequency also decreased

over the three assessments, and this trend was significant for the right ear (p <.05).

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FIGURE 4.5: TOTAL TQ SCORES BY THERAPY GROUP AND TIME PERIOD. ERROR

BARS REPRESENTING 95% CI INTERVAL.

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A B ! !

! ! C D

! !

FIGURE 4.6: A. MEAN OF TOTAL FEAR SCORES BY THERAPY GROUP AND TIME

PERIOD. B. MEAN OF TOTAL DEPRESSION SCORES BY THERAPY GROUP AND

TIME PERIOD. C. MEAN OF TOTAL HQ SCORES BY THERAPY GROUP AND TIME

PERIOD. D. MEAN OF TOTAL VAS SCORES OF TINNITUS LOUDNESS BY THERAPY

GROUP AND TIME PERIOD. ERROR BARS REPRESENTING 95% CI INTERVAL.

When comparing the effects over time between the two treatment groups, there was a

significant effect on the TFI-subscale Relaxation between the TRT/CBT group and the

TRT/EMDR group (p < .05). Post-hoc comparisons revealed that the TRT/CBT group did

not show a significant change in the follow-up period (p > .05), whereas the TRT/EMDR

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group did (p < .05). A mean decrease of 20.3 points in the TRT/CBT group in comparison

to a mean decrease of 11.7 in the TRT/EMDR group was found at T1. Between T1 and T2,

the TRT/CBT group showed a slight increase of 2.0 points and the TRT/EMDR group

showed a significant decrease of 9.5 points. Second, a significant difference in

improvement (p < .05) was indicated on the TQ-subscale Somatic complaints. The

TRT/CBT group improved significantly from T0 to T1 (p <. 01) (mean = .7), whereas the

TRT/EMDR group improved significantly from T1 to T2 (p < .05) (mean = .5).

Subsequently, on the VAS for mean tinnitus loudness, a significant difference in decrease

was detected in favor of the TRT/CBT therapy between pre-therapy and post-therapy (p

< .01), with this group showing a mean improvement of 16 points (p <. 001) in comparison

to a mean improvement of 4 points in the TRT/EMDR group. The TRT/EMDR group

showed a significant improvement over time (p < .05), but the post-hoc comparisons

between the time points were not significant. No significant differences were found on the

other primary or secondary outcome measurements.

Finally, the analysis of the GPE shows a positive effect of the bimodal therapy approach

(p < .001). The GPE does not differ significantly between the two treatment groups.

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TABLE 7 Primary and secondary outcome measures at baseline, after treatment and 3

months after treatment

T0 Pre-treatment T1 Post-treatment (after 10 T2 Follow – up (baseline) therapy sessions) (after 3 months) Primary outcomes

Tinnitus Functional Index (SD)

à Bimodal therapy 1 53.88 (18.40) 42.18 (20.67) 37.71 (21.41) (TRT/EMDR) à Bimodal therapy 2 49.60 (21.93) 33.56 (23.15) 34.49 (23.63) (TRT/CBT) Secondary outcomes

Tinnitus Questionnaire (SD)

à Bimodal therapy 1 39.65 (15.19) 31.26 (17.69) 27.74 (17.10) (TRT/EMDR) à Bimodal therapy 2 41.21 (17.04) 29.40 (18.35) 29.26 (18.55) (TRT/CBT) Hyperacusis Questionnaire (SD)

à Bimodal therapy 1 22.98 (7.29) 20.22 (7.75) 19.46 (7.81) (TRT/EMDR) à Bimodal therapy 2 22.44 (9.02) 17.93 (9.17) 19.00 (9.16) (TRT/CBT) Hospital Anxiety and Depression Scale (SD) Anxiety

à Bimodal therapy 1 9.39 (4.11) 8.00 (3.37) 7.26 (3.56) (TRT/EMDR) à Bimodal therapy 2 9.49 (4.57) 6.90 (4.36) 6.74 (4.97) (TRT/CBT) Depression

à Bimodal therapy 1 7.54 (4.39) 6.24 (3.95) 5.54 (4.14) (TRT/EMDR) à Bimodal therapy 2 7.26 (4.03) 4.86 (4.31) 5.12 (4.40) (TRT/CBT)

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T0 Pre-treatment T1 Post-treatment (after 10 T2 Follow – up (baseline) therapy sessions) (after 3 months) Visual Analogue Scale loudness (SD) à Bimodal therapy 1 60.49 (23.90) 56.83 (23.75) 52.57 (26.78) (TRT/EMDR) à Bimodal therapy 2 59.55 (21.57) 44.83 (25.72) 46.00 (26.68) (TRT/CBT) Global Perceived Effect

à Bimodal therapy TRT/EMDR .78 (.76) • TRT

1.32 (.96) • TRT + EMDR

à Bimodal therapy TRT/CBT .92 (.86) • TRT

1.32 (.85) • TRT + CBT

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TABLE 8 Group differences for primary and secondary outcomes

TIME TREATMENT x TIME

T0 T1 T0 T1

Primary outcome

Tinnitus Functional Index 15.11 (4.96)*** -.60 (-.26) 1.06 (.25) 5.07 (1.58)

Secondary outcome

Tinnitus Questionnaire 11.95 (5.44)*** .09 (.05) -.04 (-.01) 3.44 (1.50)

Hyperacusis Questionnaire 3.44 (3.12)** -1.11 (-1.34) 0.08 (.05) 1.87 (1.63)

Hospital Anxiety and Depression Scale

Anxiety 2.74 (4.64)*** .11 (.25) -.61 (-.75) .63 (1.01)

Depression 2.14 (3.68)*** -.36 (-.81) -.14 (-.17) 1.05 (1.73)

Visual Analogue Scale tinnitus loudness 14.70 (4.05)*** -1.08 (-.39) -6.81 (-1.35) 5.34 (1.40)

ESTIMATES (T-VALUES) FOR THE EFFECT OF TIME AND TREATMENT GROUP ON

THE PRIMARY AND SECONDARY OUTCOME MEASURES. REFERENCE CATEGORY

IS T2 AND CBT. P-VALUES ARE SHOWN WITH AN ASTERISK:

<0.05 (*) <0.01 (**) <0.001 (***).

4.4 DISCUSSION

In the present study the effect of two bimodal therapies in the treatment of chronic,

subjective tinnitus was compared. TRT was included in the treatment protocol to create a

baseline therapy level. Starting from the same amount of psychoeducation - due to the

TRT therapy - in every therapy group a comparison could be made between EMDR and

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CBT. The implementation of TRT also reduced the risk of bias as patients were given

treatment and thus prevented the risk of drop-out.

The primary interest was to investigate whether EMDR could be implemented in the

treatment of tinnitus. The most interesting finding was that TRT/EMDR showed clinically

significant decrease in tinnitus complaints and associated life domains in comparison to

TRT/CBT in the current study protocol. There was no inferiority found for bimodal therapy

TRT/EMDR compared to bimodal therapy TRT/CBT. Both treatment arms resulted in a

clinically significant improvement of the TFI total score (i.e. a decrease of ≥13 points)

(Meikle, Henry et al. 2012). Moreover, the participants also showed significantly decreased

scores on the TQ, HQ, HADS and VAS for tinnitus loudness. The present study has shown

that both therapeutic trajectories offer clinically significant improvement for patients

suffering from tinnitus and hyperacusis. Previous research has shown that CBT for

hyperacusis shows promising results (Jüris, Andersson et al. 2014). This RCT highlights

the positive effects of TRT/CBT and TRT/EMDR on tinnitus complaints and the high

prevalent comorbid complaints such as hypersensitivity to sounds, anxiety and

depression.

The power of the current study design was calculated to detect a difference in effect

between the two treatments. This RCT, with 43 and 46 persons in the two treatment

groups, offers 80% power to detect a difference in effect (i.e. decrease of ≥13 points on

the TFI) of 0.6 standard deviations (Cohen’s D) between both groups at a significance level

of 0.05. Assuming that the standard deviation within the treatment groups is around 20

(Table 3), this would imply a difference in effect of 12 units between both treatments.

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Increasing the sample size to 400 individuals per group would have a power of 80% to

detect a difference of 0.4 standard deviations, which is equivalent to a difference in 8 units

between both groups.

Therefore, the current study is only able to detect large differences in effect between the

two treatments. The non-significance of the interaction between treatment and time may

be attributable to a lack of power in the current study, that does not allow to detect subtle

differences in effect. In this context we do want to point out the strong significant

therapeutic effect that was detected in both therapy arms. Therefore, it would have been

challenging to significantly transcend the obtained improvement by one or the other

bimodal treatment.

Notably, previous research concerning the comparison between EMDR and CBT

demonstrates similar outcome with no significant differences in the treatment of PTSD (Van

Etten and Taylor 1998, Seidler and Wagner 2006, de Roos, Greenwald et al. 2011, Ho

and Lee 2012), panic (Faretta 2013), and obsessive compulsive disorder (Marsden, Lovell

et al. 2018). Based on the AIP-model, EMDR may promote plasticity of the brain causing

adjustment of neural networks and the development of new adaptive networks. This theory

supports the findings of Jastreboff & Jastreboff (2000) indicating that retraining the brain

to achieve habituation of the tinnitus-induced reactions and tinnitus perception is due to

the plasticity of the neural networks. Memory mechanisms are known to have a major

impact on the persistence of the awareness of the phantom percept and the associated

distress (De Ridder, Elgoyhen et al. 2011). Aiming at reorganizing different networks

containing the hippocampus, parahippocampus, anterior insula, amygdala, subgenual

and dorsal anterior cingulate cortex, parietal cortex, posterior cingulate cortex and

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precuneus, and prefrontal cortex is therefore necessary (De Ridder, Elgoyhen et al. 2011).

The decrease in frontal activation and the increase of limbic processing as a consequence

of bilateral stimulation could result in effective information processing causing the tinnitus

percept to change (Herkt, Tumani et al. 2014, Boukezzi, El Khoury-Malhame et al. 2017).

Furthermore, our results are consistent with the findings of the pilot study of Rikkert et al.

(Rikkert, Van Rood et al. 2018) reporting significant reduction on the TFI after EMDR-

treatment. The other exploratory study on EMDR and tinnitus (Phillips, Erskine et al. 2019)

also showed an improvement after treatment with EMDR with a mean decrease of 20

points on the THI which remained stable at the 6-month follow up. Similar to our study,

Rikkert et al. conducted a 3-month follow up, also concluding a stable treatment effect

over time.

Different theories have been considered on the working mechanisms of EMDR such as

the working memory account, classic conditioning, physiological changes associated with

the orienting response, REM sleep, changes in interhemispheric connectivity, neural

integration and thalamic binding, and structural and functional brain changes (Landin-

Romero, Moreno-Alcazar et al. 2018). Still no unanimity has been reached on the most

explanatory model. There is abundant room for further progress in determining which

components of effective treatments tackle the reorganization of the responsible neural

correlates, but these matters are beyond the scope of this study. No substantial evidence

was found to explain the significant intergroup differences on the TFI-subscale Relaxation,

TQ-subscale Somatic complaints and VASLoudness after treatment that were found in this

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study. We speculate that different therapeutic interventions integrated in a different way

over time and reflected the progress during the treatment course.

The current randomized controlled trial holds several strengths. Participants were randomly

assigned to one of the two treatment conditions by using a stratification paradigm

according to TFI grade. The heterogeneous group of patients indicate generalisability for

both treatments. A realistic presentation of the current tinnitus population with the

occurrence of sleep difficulties, anxiety and depressive symptoms was investigated. More

than 50% of the participants reported experiencing tinnitus for more than 5 years and tried

several therapies in the past without success. This clinical study has included an

appropriate sample size. Only two patients were unable to complete the therapeutic

trajectory. The drop-out rate was very low indicating that patients were motivated, and a

positive therapeutic alliance was built. The study design enhanced the compliance with

the treatment.

A double-blind design was used, for the participants, for the investigator and the TRT-

therapist. Only the psychotherapist conducting the CBT and EMDR treatments was

unblinded. All patients received the same amount of contact hours and were treated by

the same therapists. Therefore, there was no bias on duration of the therapy and therapist

effects could be controlled. However, this could also be considered a shortcoming as a

‘crossed therapist design’ could influence outcome if an allegiance towards one therapy

exists (Falkenström, Markowitz et al. 2013). This possible bias was assessed in this study

and no differential psychotherapist allegiance was found.

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The GPE served as assessment to achieve data about the level of improvement after

treatment. Evaluations of the patients on the GPE scale provided valuable information

about the capital gain of the treatment providing insights into the experiences of the tinnitus

sufferers. More than 81% of the patients reported improvement after the TRT/EMDR

treatment and more than 84% described reduction of tinnitus complaints after the

TRT/CBT intervention and expressed feeling better to a lot better. Previous research has

emphasized the importance of tailored treatment and the uniqueness of every tinnitus

patient (Shi, Robb et al. 2014, Van de Heyning, Gilles et al. 2015). Therefore, we stress

the need to listen carefully to each individual patient and focus on their needs.

The design of the study had some constraints. The implementation of an active control

group was indicated to investigate the efficacy of EMDR compared to the known effective

treatment. Unfortunately, placebo effects are difficult to rule out when using an active

control design (Boot, Simons et al. 2013). Even though there are risks associated with an

active control group, it would have been unethical to abstain these patients with

bothersome tinnitus from the actual treatment. A placebo treatment could be considered,

but one might question if the presence and attention given by a health professional could

enhance hope, expectations and reassurance, as a waiting list condition could also induce

the same effects. Investigating psychotherapy comes with these particular challenges

(Boot, Simons et al. 2013). The prior concern should be the well-being of the patient and

the focus on mental and physical resilience.

The effectiveness of both therapies may be due to the common factors present in EMDR

and CBT. Lambert et al. (2016) state that different areas can influence client outcome,

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namely specific therapy techniques, expectancy effects, extra therapeutic factors, and

common factors. Studies on psychotherapeutic interventions have demonstrated that

common factors such as empathy, congruence, unconditional positive regard, and the

therapeutic alliance correlate more highly with client outcome than specialized treatments

(Lambert 2016, Cuijpers, Reijnders et al. 2019).

The current RCT reports effectivity for two different effective bimodal therapies. Remarkably

it seems that effectivity may find the basis in the specific treatment elements and more

importantly in common factors such as the therapeutic alliance. Moreover, to develop a

full picture of the effectivity and implementation of EMDR in the treatment of chronic,

subjective tinnitus, additional studies are required. In future investigations, it might be

possible to use a control group that can take several variables into account such as

specific therapy techniques, expectancy effects, and common factors, which all can have

an effect on the client outcome. Additionally, recent attention has been given to the

relations between tinnitus distress and personality traits and consequently the inevitable

impact on treatment (Simoes, Schlee et al. 2019). Future research may focus on these

elements as possible key factors for effectivity in the treatment of tinnitus.

In conclusion, these results indicate that there might be a different effect or influence on

certain life domains caused by either EMDR or CBT resulting in better coping strategies,

different associations and reactions towards the tinnitus. However, a clear superiority of

TRT/EMDR in the treatment of tinnitus could not be identified in this analysis. Evidence

was found that both therapies prove to lead to significant improvement of the tinnitus

perception and the tinnitus distress.

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147260 Luyten BNW.indd 154 22-12-2020 13:55

INFLUENCING FACTORS

IN TINNITUS TREATMENTPART III

INFLUENCING FACTORS IN TINNITUS TREATMENT

Part III Part

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147260 Luyten BNW.indd 156 22-12-2020 13:55

CHAPTER FIVE THE INFLUENCE OF PERSONALITYTHE TRAITS INFLUENCE IN OF THE PSYCHOTHERAPEUTICPERSONALITY TRAITS IN THE TREATMENT OF 5 PSYCHOTHERAPEUTIC CHRONIC TINNITUS TREATMENT OF CHRONIC

TINNITUS

Under review in Journal of Psychosomatic Research

Luyten, T., Cardon, E., Jacquemin, L., Van de Heyning, P., Van Looveren, N.,

Declau, F., Fransen, E., De Bodt, M., Van Rompaey, V., & Gilles, A. 2020.

Journal of Psychosomatic Research Luyten, T., Cardon, E., Jacquemin, L., Van de Heyning, P., Van Looveren, N., Declau, F., Fransen, E., De Bodt, M., Van Rompaey, V., & Gilles, A.

Under review in Journal of Psychosomatic Research, 2020. Chapter Chapter

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5. THE INFLUENCE OF PERSONALITY TRAITS IN THE

PSYCHOTHERAPEUTIC TREATMENT OF CHRONIC

TINNITUS

ABSTRACT

Introduction: This study was set out to investigate whether specific personality traits are

significant predictors of therapeutic outcome. A prospective analysis was performed on

the data of 82 chronic subjective tinnitus patients treated with a combined Tinnitus

Retraining Therapy (TRT) / Cognitive Behavioral Therapy (CBT) and TRT / Eye Movement

Desensitization and Reprocessing (EMDR) psychotherapeutic treatment.

Methods: The Dutch version of the Big Five Inventory (BFI-II) was implemented as primary

outcome measure. A multiple regression was performed to investigate the effect of BFI-II

traits on tinnitus distress, measured by the Tinnitus Functional Index (TFI), at baseline and

on the difference in TFI scores between baseline and post treatment. A k-means cluster

analysis was conducted to investigate the study population according to their scores on

the five BFI domains.

Results: In general, high Conscientiousness (p < 0.01) and high Negative Emotionality (p

< 0.01) significantly predicted lower therapeutic response. K-means clustering resulted in

an optimal solution with four clusters based on BFI personality traits. Cluster membership

significantly affected treatment outcome. Post hoc comparisons showed that the

therapeutic effect was significantly higher in a cluster characterized by high levels of

Extraversion, Agreeableness and Open-Mindedness and lower levels of

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Conscientiousness and Negative Emotionality.

Conclusion: Personality traits, more specifically the combination of low Conscientiousness

and low Negative Emotionality, appear to be predictors for improvement after

psychotherapeutic treatment for tinnitus. These data could lead to the development of a

more tailored treatment protocol adapted to the personality of the tinnitus patient.

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5.1 INTRODUCTION

The perception of tinnitus, an internal sound in the absence of external auditory input,

tends to be individual-dependent (Cederroth, Gallus et al. 2019). In 8 – 20% of the

population, tinnitus sounds raise awareness and become chronic (Baguley, McFerran et

al. 2013, Van de Heyning, Gilles et al. 2015). For about 1 – 3 %, tinnitus becomes

distressing (Baguley, McFerran et al. 2013, Jacquemin, Mertens et al. 2019). This raises

questions about why tinnitus is perceived as debilitating by one individual and has no

significance to another individual. The role of personality traits in experiencing tinnitus

distress requires important clinical attention (Kleinstäuber, Weise et al. 2018, Biehl,

Boecking et al. 2019, Searchfield, Linford et al. 2019, Simoes, Schlee et al. 2019).

Personality studies show that individual variability in terms of patterns of thinking,

processing of emotions, and experiencing bodily sensations can be summarized in the

Big Five personality domains (Soto and John 2017) and these traits, i.e. ‘Neuroticism’,

‘Extraversion’, ‘Openness’, ‘Agreeableness’, and ‘Conscientiousness’, have been

investigated in previous studies (Langguth, Kleinjung et al. 2007, Kleinstäuber, Jasper et

al. 2013, Mucci, Geocze et al. 2014, Kleinstäuber, Frank et al. 2015, Kleinstäuber, Weise

et al. 2018, Simoes, Schlee et al. 2019).

Findings indicate that the facet trait ‘Anxiety’ and personality trait ‘Neuroticism’ are

associated with the presence of depressive symptoms and tinnitus severity (Langguth,

Kleinjung et al. 2007). More specifically, it was shown that tinnitus patients score higher

on Neuroticism and lower on Agreeableness. Research on the correlates of panic disorder

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(PD) and tinnitus showed differential brain patterns in comorbid tinnitus (with PD) compared

to only tinnitus (without PD) and healthy controls (Pattyn, Vanneste et al. 2018).

Furthermore, Simoes et al. identified ‘Neuroticism’ and ‘Extraversion’ as significant

predictors of tinnitus distress over time and these traits can statistically distinguish patient

groups with relevant changes over a period of time (Simoes, Schlee et al. 2019).

Personality profiles or the clustering of traits and features have also been investigated in

tinnitus research (Welch and Dawes 2008, Bartels, Middel et al. 2010, Durai, O’Keeffe et

al. 2017). Somatoform disorder clusters and higher levels of anxiety and depression have

been discovered in tinnitus patients (Belli, Belli et al. 2012). A review defined the

combination of low Extraversion, high Neuroticism, high stress reaction, lower social

closeness, lower well-being, lower psychological acceptance, externalized locus of

control and the presence of a type D (i.e. distressed) personality to be clearly associated

to tinnitus distress (Durai and Searchfield 2016). According to the methodological

framework a combination of factors is clustered, but so far, no typology has come to a

consensus based solely on the BFI.

Implications of personality on the effectiveness of treatment might be of crucial importance

in contemporary tinnitus management. Individual factors, such as personality traits, are

possibly important markers to explain low levels of evidence in treatment outcome

(Cederroth, Gallus et al. 2019). To date, the pressure is on to focus on cost-effectiveness.

No golden standard has been established for the most effective tinnitus treatment.

European Guidelines strongly recommend clinical management with application of

Cognitive Behavioral Therapy (CBT) and a stepped-care multidisciplinary approach (Cima,

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Mazurek et al. 2019). This stepwise therapeutic management makes differentiation

between patients possible, providing a short therapy process including psychoeducation

for all patients and gradually expanding the treatment if necessary. Other

psychotherapeutic treatment methods such as Tinnitus Retraining Therapy (TRT), a

psycho-educative and habituation oriented therapy (Phillips and McFerran 2010, Seydel,

Haupt et al. 2010, Jastreboff 2015), and Eye Movement Desensitization and

Reprocessing (EMDR), containing of an eight-phased treatment protocol, have also shown

significant improvement (Rikkert, Van Rood et al. 2018, Phillips, Erskine et al. 2019).

The current study is set out to investigate the influence of personality traits in the

psychotherapeutic treatment of chronic subjective tinnitus. We aimed to investigate

whether specific personality traits are significant predictors of therapeutic outcome in a

bimodal therapy of TRT and either CBT or EMDR. The main focus of this prospective

analysis consisted of the following research questions: (1) Do personality traits, measured

by the BFI-II, influence tinnitus severity and tinnitus distress and (2) is treatment outcome

influenced by certain personality traits? Hypotheses, based on previously described

literature, were summarized as (a) TFI-scores at baseline correlate positively with negative

emotionality, (b) TFI-scores at baseline correlate negatively with extraversion and open-

mindedness, (c) decreases in TFI-score after treatment (i.e. D TFI) correlate positively with

extraversion and open-mindedness, and (d) poor treatment outcome correlates negatively

with high negative emotionality.

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5.2 METHODS

5.2.1 Study design

The present study is the result of a prospective study. All data were obtained by the

randomized controlled trial registered at ClinicalTrials.gov, number NCT03114878. The

study protocol was approved by the Ethical Committee of the Antwerp University Hospital

on 17 October 2016. The protocol describes the extensive study design including

treatment procedures and can be consulted in Luyten et al. (2019). A total of 89

participants were randomized into two treatment groups: TRT/CBT (n = 43) or TRT/EMDR

(n = 46). Each group received 5 sessions of TRT and 5 sessions of either CBT or EMDR,

with one session each week. Assessment was performed before treatment (T0), after

treatment (T1), and follow-up three months after the last treatment session (T2). All

participants received the Big Five Inventory (BFI) – II – questionnaire in Dutch after the

follow-up (Denissen, Geenen et al. 2008).

5.2.2 Participants

A total of 82 patients responded and completed the BFI-questionnaire. Seven participants

were lost to follow-up for analysis of the personality traits. Patients aged between 18 to 75

(mean: 48.4 +- 12.57; male = 59, female = 23) years were eligible for inclusion in this

study. Prior to inclusion for the RCT a diagnosis of chronic, subjective, non–pulsatile

tinnitus was set. Table 9 summarizes the most relevant baseline demographic

characteristics of the included patients. No statistically significant differences were

observed concerning the demographic characteristics of both treatment groups.

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TABLE 9. Baseline demographic characteristics of all participants.

Characteristics Total TRT/EMDR TRT/CBT p value

Number of subjects 82 38 44 Age: mean (SD) 48.4 (12.57) 47.59 (12.5) 49.34 (12.75) 0.5326 Gender: male / 59 / 23 29 / 15 30 / 8 0.1869 female Questionnaires TFI: mean (SD) 52.02 53.84 (18.59) 49.91 (21.76) 0.3794 (20.09) HQ: mean (SD) 22.46 (8) 22.91 (7.43) 21.95 (8.67) 0.5902 HADS § Anxiety: mean (SD) 9.39 (4.27) 9.39 (4.13) 9.39 (4.47) 0.993 § Depression: mean 7.32 (4.04) 7.45 (4.43) 7.16 (3.59) 0.7426 (SD)

NOTE: TRT: TINNITUS RETRAINING THERAPY; CBT: COGNITIVE BEHAVIOURAL

THERAPY; EMDR: EYE MOVEMENT DESENSITIZATION AND REPROCESSING; TFI:

TINNITUS FUNCTIONAL INDEX; HADS: HOSPITAL ANXIETY AND DEPRESSION

SCALE; HQ: HYPERACUSIS QUESTIONNAIRE.

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5.2.3 Outcomes

The Dutch version of the Big Five Inventory (Denissen, Geenen et al. 2008) was

implemented as the primary outcome measure. This self-report questionnaire contains 60

items with a forced-choice of 5 items (e.g. totally disagree – disagree – don’t agree/don’t

disagree – agree – totally agree). A total of 5 personality traits and 15 specific facets are

extracted. Appendix D summarizes the personality dimensions of the BFI. The personality

trait Neuroticism that was defined in the BFI, is now labelled as Negative Emotionality, as

is Openness, currently described as Open-Mindedness in the BFI-II (Soto and John 2017).

5.2.4 Statistical analysis

A primary multiple linear regression analysis was performed to explore the influence of

The R Foundation for Statistical Computing). First, to illuminate the effect of personality

traits on baseline tinnitus severity, a multiple regression was performed to investigate the

effect of all five BFI scores on TFI scores at baseline. Then, a model was designed

exploring the effect of BFI scores on the difference in TFI scores between baseline and

follow-up (ΔTFI), to examine the possible effects of personality traits on response to

psychotherapeutic therapy. To correct for possible differences between both therapy

groups, interactions between group and BFI personality traits were added to the model.

As personality traits are highly interdependent and multiple traits often work together to

form certain ‘personality types’ (Gerlach, Farb et al. 2018), a secondary cluster analysis

was performed to further explore the effects of personality on tinnitus severity and

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treatment. K-means clustering was performed to divide the study population in a number

of clusters according to their scores on the five BFI domains. The number of clusters was

not prespecified. The optimal number of clusters was determined based on the sum of

squared errors. Differences in (1) TFI scores at baseline and (2) ΔTFI between clusters

were explored using linear regression models with cluster membership as an independent

variable.

5.3 RESULTS

An overview of mean scores on each BFI personality trait and facet trait is presented in

Table 10. None of the scores on the five BFI domains differed significantly between therapy

groups. However, for some domains such as Agreeableness and Open-Mindedness,

differences in scores showed an apparent tendency (p = 0.0502 and p = 0.065,

respectively). To account for possible differences in personality traits of participants

between groups, therapy group was considered as an independent variable for further

analysis.

First, a multiple linear regression analysis correcting for possible differences between

therapy groups was used to test if personality traits significantly influenced TFI scores at

baseline. The results of the regression revealed a non-significant trend of the combined

BFI personality traits on baseline TFI scores in this study population (p = 0.0761, F (10,71)

= 1.801, R² = 20.23%). The factor Extraversion significantly affected TFI at baseline (β = -

0.36, p < 0.05), as did the interaction between scores on Open-Mindedness and therapy

group (β = -1.65, p < 0.05). Additionally, separate simple linear regression analyses

showed that the BFI trait Negative Emotionality also showed a non-significant trend on TFI

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scores at baseline, independently from therapy group (β 0.20, p = 0.0678). An overview

of all correlations between BFI scores and TFI scores at baseline for each therapy group

is provided in figure 5.1.

TABLE 10 Personality Scores

Personality traits Specific facet traits Total TRT/EMDR TRT/CBT p value

Extraversion 40.1 39.3 (7.86) 41.03 (8.1) 0.3298 (7.97) Sociability 13.12 12.8 (3.75) 13.5 (3.2) (3.5) Assertiveness 13.59 13.34 (2.61) 13.87 (3.32) (2.96) Energy Level 13.39 13.16 (3.05) 13.66 (3.31) (3.16) Agreeableness 46.66 48.18 (5.83) 44.89 (9) 0.0502 (7.6) Compassion 16.09 16.27 (2.66) 15.87 (3.25) (2.94) Respectfulness 16.63 17.3 (2.06) 15.87 (3.6) (2.95) Trust 13.94 14.61 (2.54) 13.16 (2.97) (2.83) Conscientiousness 46.96 48.27 (6.94) 45.45 (9.29) 0.1196 (8.18) Organization 15.5 16.2 (3.44) 14.68 (4.21) (3.87) Productiveness 15.48 15.59 (2.94) 15.34 (3.23) (3.06) Responsibility 15.99 16.48 (2.25) 15.42 (3.13) (2.73) Negative Emotionality 35.4 34.98 (6.93) 35.89 (8.93) 0.6021 (7.88) Anxiety 13.89 14.32 (2.95) 13.39 (2.99) (2.99) Depression 10.59 10.39 (2.86) 10.82 (3.55) (3.19) Emotional Volatility 10.93 10.27 (3.01) 11.68 (3.45) (3.28) Open-Mindedness 44.13 45.77 (9.11) 42.24 (7.8) 0.0650 (8.66) Intellectual Curiosity 14.73 15.05 (3.22) 14.37 (2.84) (3.05) Aesthetic Sensitivity 13.82 15.07 (4.26) 12.37 (4.05) (4.35) Creative Imagination 15.59 15.66 (3.09) 15.5 (3.52) (3.27)

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p ( grou s between interaction the did as p<0.05), 0.36, showed that the BFI trait Negative Emotionality also showed also anon Emotionality Negative trait BFI the showed that = 1.801, R² = 1.801, F(10,71) = 0.0761, (p population study this in scores TFI onbaseline ts trai personality BFI anon revealed regression the of Theresults baseline. at scores TFI influenced significantly traits personality if test was usedto groups therapy regression linear amultiple First, anal further for variable anindependent as was considered group therapy groups, between participants of traits personality in differences possible for Toaccount respectively). andp= = 0.065, 0.0502 (p tendency t showed anapparen scores in differences andOpen Agreeableness as some such domains for However, groups. T mean pe on of eachBFI scores An overview RESULTS 5.3 variable. membership asanindependent cluster models with regression linear using were explored Δ and (2) baseline at scores TFI (1) in Differences s. error squared base was determined clusters number of Theoptimal prespecified. not was clusters Thenumber of domains. BFI five onthe scores their to according clusters of treatment. K

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Mindedness H

FIGURE 5.1 CORRELATIONS BETWEEN PERSONALITY TRAITS AND TINNITUS SEVERITY. 1A: CORRELATIONS BETWEEN BFI A P

TRAIT SCORES AND TFI SCORES AT BASELINE. 1B: CORRELATIONS BETWEEN BFI TRAIT SCORES AND ΔTFI SCORES (I.E. T E R DIFFERENCES IN TFIβ AT FOLLOW-UP AND TFI AT BASELINE). CORRESPONDING CORRELATION COEFFICIENTS AND P VALUES =

- ,

22-12-2020 13:55 ARE PROVIDED IN THE UPPER LEFT CORNER.

CHAPTER 5

The main analysis considered the effect of BFI personality traits on treatment response. In

order to test whether BFI scores predicted response to treatment, a multiple regression

analysis was performed with the dependent variable ΔTFI, i.e. the difference between TFI

scores at follow-up and TFI scores at baseline. TFI scores at baseline were also included

in this analysis, as these were found to significantly affect treatment response. No

interactions between therapy group and BFI scores were found to have a significant effect

on the outcome, and subsequently, these interactions were eliminated from the model.

Thus, the final model included all BFI personality traits and TFI scores at baseline as

independent factors. These predictors explained 30.92% of the total variance (p < 0.0001,

F (6,75) = 5.59, R² = 30.92%). Conscientiousness (β = -0.36, p < 0.01) and Negative

Emotionality (β = -0.33, p < 0.01) significantly predicted ΔTFI scores, as did TFI scores at

baseline (β = 0.46, p < 0.001). Post hoc linear regression analyses revealed separate

non-significant effects of both Conscientiousness (β = -0.18, p = 0.11) and Negative

Emotionality (β = -0.17, p = 0.14) on ΔTFI scores, indicating that the effects of different

BFI trait scores on treatment response were not independent of each other. Figure 5.1B

presents an overview of the correlations between the five separate BFI personality traits

and ΔTFI scores for each therapy group.

As it was shown that effects of different BFI personality traits on baseline TFI and ΔTFI

scores were not independent of each other, and as it is known that different personality

traits can be combined into distinct ‘personality types’ (Gerlach, Farb et al. 2018), a cluster

analysis was performed to verify the effects of personality traits on tinnitus treatment

response. Based on the percentage of variance explained by k-means clustering solutions

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for two up to seven clusters, a solution with four clusters was considered as optimal.

Figure 5.2 presents an overview of the characteristics of the members of these four

clusters. Overall, members of cluster 2 score high on Negative Emotionality but lower on

the four remaining BFI trait scores. Clusters 1, 3 and 4 are more similar, with marked

differences in scores on the Conscientiousness (lower in cluster 1) and Open-Mindedness

(lower in cluster 3) scales.

FIGURE 5.2 RESULTS OF THE K-MEANS CLUSTERING ANALYSIS. BFI SCORES ARE PRESENTED AS NORMALIZED Z-SCORES. INDIVIDUAL BFI SCORES ARE REPRESENTED BY THIN LINES; MEAN SCORES FOR EACH CLUSTER ARE REPRESENTED BY A THICK LINE. E: EXTRAVERSION, A: AGREEABLENESS, C: CONSCIENTIOUSNESS, N: NEGATIVE EMOTIONALITY, O: OPEN-MINDEDNESS.

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No significant differences in TFI scores at baseline between clusters were found (Fig. 5.3

A). A multiple linear regression analysis was performed in order to test whether cluster

membership could predict treatment outcome, i.e. ΔTFI scores. Similarly, to the primary

analysis, with the addition of TFI scores at baseline as an independent variable, treatment

group did not contribute significantly and was removed from the model.

Results of the regression analysis showed that baseline TFI scores and cluster

membership together could explain 21.61% of the total variance (p < 0.001, F (4,77) =

5.31, R² = 21.61%). An analysis of variance (ANOVA) confirmed that the final model,

including cluster membership, performed significantly better than a model including only

TFI scores at baseline as an independent variable (p < 0.05, F (1,3) = 2.81). Thus, cluster

membership functioned as a meaningful predictor of ΔTFI scores. Post hoc comparisons

showed that ΔTFI scores were significantly higher in cluster 1 than in clusters 2 (p < 0.01)

and 4 (p < 0.05), but not cluster 3 (p = 0.11) (Fig. 5.3 B).

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FIGURE 5.3 EFFECT OF CLUSTER MEMBERSHIP ON TFI SCORES.

3A: NO SIGNIFICANT DIFFERENCES IN TFI SCORES AT BASELINE WERE FOUND BETWEEN CLUSTERS. 3B: MEMBERS OF CLUSTER 1 ACHIEVED SIGNIFICANTLY HIGHER ΔTFI SCORES THAN MEMBERS OF CLUSTER 2 AND 4.

*: P < 0.05, **: P < 0.01.

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5.4 DISCUSSION

The main focus of this prospective analysis considered the effect of personality traits on

outcome of a psychotherapeutic tinnitus treatment. We report that personality, especially

the BFI domains Negative Emotionality and Conscientiousness, affects treatment

response in a population of chronic subjective tinnitus patients.

First, we investigated whether personality traits influence tinnitus severity and tinnitus

distress at baseline. This initial objective was addressed conducting a multiple linear

regression analysis. Scores on the factor Negative Emotionality tended to correlate

positively with TFI scores at baseline but showed no significant effect. Furthermore, scores

on the factor Extraversion correlated negatively with TFI scores, as did scores on the factor

Open-Mindedness, although this effect was found to depend on therapy group. These

findings are consistent with the review on personality traits relevant to tinnitus of Durai et

al. who concluded that high Neuroticism, labelled as Negative Emotionality in the BFI-II

(Soto and John 2017), and low Extraversion are associated with tinnitus distress (Durai

and Searchfield 2016).

To explore the influence of personality traits on treatment outcome, a multiple regression

analysis was carried out with ΔTFI as dependent variable. No significant difference in BFI

personality traits were found between therapy groups. There was no significant positive

correlation between high scores on the factors Extraversion and Open-Mindedness and

treatment outcome. Kleinstäuber et al. (2018) showed that high Openness, labelled as

Open-Mindedness in the BFI-II (Soto and John 2017), predicted lower tinnitus complaints

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measured by the Tinnitus Handicap Inventory (THI) after treatment by internet-based CBT

(iCBT). Also, the study of Simões et al. (2019) showed that increasing tinnitus distress

over time is associated with higher Neuroticism and improvement is associated with higher

Extraversion. The findings presented here show a similar tendency, but no significant

correlations could be defined for Open-Mindedness and Extraversion.

In agreement with former studies (Simoes, Schlee et al. 2019), scores on the factor

Negative Emotionality significantly correlated negatively with a decrease of TFI scores,

indicating that patients with higher Negative Emotionality showed less improvement.

Additionally, the analysis revealed a similar significant correlation with the factor

Conscientiousness. This outcome is contrary to that of Kleinstäuber et al. (2018) who

observed that high scores on the factor Conscientiousness predicted favorable treatment

outcome for iCBT. A possible explanation for this difference might be the application of

the specific treatment method. An internet-based approach might elicit the sense of

responsibility for the treatment outcome for persons with high levels of Conscientiousness

and enhance engagement to one’s self (Kleinstäuber, Weise et al. 2018).

Conscientiousness is related to the will for achievement and commitment to work (Costa

Jr, McCrae et al. 1991). Therefore, this personality trait could stimulate coping behavior to

complete an iCBT program.

Lower levels of Conscientiousness may result in maladaptive coping. Conscientiousness

is found to be positively related to active coping and negatively correlated to depression

and perceived stress (O'Cleirigh, Ironson et al. 2007). Aside from this, it may be that

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participants with lower levels of Conscientiousness, i.e. the facets Organization,

Productiveness and Responsibility, experience challenges in the area of executive

functions.

Within psychotherapeutic treatment, interventions are integrated to facilitate stress

management, organization, focusing, and attention switching. The role of impairment in

executive functions in the prefrontal cortex as important factor for the perseverance of

chronic tinnitus is already well established in previous research (Vanneste, Van de Heyning

et al. 2011, Vanneste, Joos et al. 2012, Araneda, Renier et al. 2018, Cardon, Jacquemin

et al. 2019). Therefore, patients with low levels of Conscientiousness might benefit more

from face – to – face therapy as the therapist also strengthens these executive challenges.

K-means clustering validated these findings. This cluster analysis culminated in the

selection of four clusters containing a specific variability of traits. The ANOVA analysis

revealed that cluster membership served as significant predictor of treatment outcome.

More specifically, the decrease of TFI scores was significantly higher in cluster 1 than in

clusters 2 and 4.

Cluster 1 revealed a combination of personality traits that can be considered as more

responsive to psychotherapeutic treatment. Participants in cluster 1 presented high levels

of Extraversion, Agreeableness and Open-Mindedness and lower levels of

Conscientiousness.

Cluster 2 was determined by high levels of Negative Emotionality and lower levels on the

other four factors. This cluster was associated with poor treatment outcome.

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Cluster 3 shows slightly higher scores on Extraversion, Agreeableness,

Conscientiousness, and lower scores on Negative Emotionality and Open-Mindedness.

In cluster 4, lower levels of Negative Emotionality and higher levels of Conscientiousness

were detected compared to cluster 1.

Interestingly, participants with a cluster 1 personality profile significantly improved after

treatment in comparison to those in cluster 4. The greatest difference between these

clusters can be found in the trait Conscientiousness. Given the fact that

Conscientiousness and Negative Emotionality both significantly predicted TFI scores at

baseline and ΔTFI scores, the role of the trait Conscientiousness in tinnitus distress and

treatment outcome cannot be ruled out. This raises important questions regarding the

impact of Conscientiousness and the implications on future treatment.

Future research should be undertaken to investigate the relationship between personality

traits and treatment outcome on a larger sample size to validate these findings. To develop

a full picture of which therapeutic trajectory is most effective for which patient, additional

studies are required to map personality traits, coping strategies, the therapeutic alliance

and process markers during therapy. However, these findings are encouraging in getting

closer to finding more directions in the heterogeneous landscape of the tinnitus population.

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5.5 CONCLUSION

In conclusion, personality traits are associated with the perception of tinnitus, the related

tinnitus distress and consequently influence treatment outcome. This prospective study

has revealed that personality traits Conscientiousness and Negative Emotionality offer

predictive and appended value in the field of tinnitus management. These findings were

validated by the multiple regression analysis as well as by k-means clustering. This study

was the first to discuss the significance of Conscientiousness in the perseverance of

tinnitus distress and the relevance of this personality trait in tinnitus treatment.

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GENERAL DISCUSSION & CONCLUSIONSCHAPTER SIX

GENERAL DISCUSSION &

6 CONCLUSIONS

Chapter

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6. GENERAL DISCUSSION & CONCLUSIONS

This doctoral thesis was performed in order to gain insight in the value of EMDR

as treatment for chronic subjective tinnitus, to investigate whether this

psychotherapeutic intervention can be applied as effective tinnitus treatment,

and to explore the influence of personality traits on treatment outcome. These

main goals were subdivided in four chapters discussing the following research

objectives:

o To describe EMDR and examine the efficacy of EMDR in the treatment

of tinnitus.

o To analyze the effect of EMDR compared to CBT in chronic subjective

tinnitus patients.

o To assess whether a bimodal therapy for chronic subjective tinnitus consisting of the combination of TRT and EMDR results in a clinically

significant different efficacy in comparison with the prevailing bimodal

TRT and CBT therapy.

o To explore the influence of specific personality traits in therapeutic

outcome.

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PART I THE VALUE OF EMDR IN THE TREATMENT OF TINNITUS

The first part of this dissertation investigated the existence of relevant EMDR -

studies conducted in the tinnitus population. Chapter 1 presents the systematic

review that analyzed EMDR as possible treatment for tinnitus. A total of 15

records were identified through electronic database searching and one additional

study was found by manual scanning. The first study on EMDR as treatment for

tinnitus was conducted over a decade ago, lacking tinnitus assessment such as

psychoacoustic measurements and tinnitus questionnaires. However, the two

eligible studies included in this systematic review were recently published,

showing promising results such as significantly decreasing tinnitus distress after

EMDR treatment for patients with moderate to severe tinnitus complaints.

This was the first systematic review ever performed on EMDR as treatment for

tinnitus resulting in an overview of the currently existing scientifically proven

studies assessed by the Platinum Standard. This assessment depicted one pilot

study of good value and one of fair quality, leaving abundantly more room and

opportunities for future trials. The conducted review warrants high-quality,

controlled studies in this specific field of research. Therefore, the study

conducted in this doctoral thesis is the first RCT on EMDR and tinnitus and the

first to offer ground-breaking insights on this topic.

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PART II A RANDOMIZED CONTROLLED TRIAL FOR EMDR IN TINNITUS

Consequently, in the second part of the thesis the focus was on the

implementation of EMDR as effective treatment for tinnitus. The study protocol for

a prospective, randomized controlled trial with blind evaluator was proposed in Chapter 2.

This protocol represented the randomization of a total of 166 patients with subjective,

chronic, non-pulsatile tinnitus in two treatment groups: TRT and CBT versus TRT and

EMDR. Scores on the TFI, VAS, TQ, HADS, HQ, psychoacoustic measurements and

Event - Related Potentials (ERPs) were carried out to investigate the therapeutic effects.

Hence, this RCT was the first research project to analyze subjective and objective

parameters as outcome measurements in psychological bimodal therapy in the treatment

of tinnitus.

The study outline, procedures, results, and conclusions were discussed in Chapter 3.

Data from 89 patients were assessed at three time-points i.e. before treatment, after

treatment, and at three month follow up. The focus in this chapter was analyzing the

subjective measurements, more specifically the TFI was implemented as primary outcome

measurement, whereas the TQ, HQ, HADS, VASLoudness, and GPE served as secondary

outcomes, after psychotherapeutic treatment.

The primary goal was to examine whether EMDR could be implemented in current tinnitus

management. To investigate the effectivity of EMDR in comparison to standard treatment,

an active control group was included in the study design. To date, the present

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recommended treatment option consists of psychoeducation and CBT. Thus, TRT was

implemented in each therapy arm as this educational-based treatment consists of a

protocollary approach which can be replicated by therapists and thus enhances validity

and reliability. Furthermore, most patients included in the study had received some

educational counseling before entering this therapeutic trajectory as a consequence of

their yearlong search for tinnitus relief. Therefore, TRT was included in the treatment

protocol to create a baseline therapy level. To anticipate the hypothesis that therapeutic

effects might be explained by TRT only, the Global Perceived Effect was implemented as

outcome measure to detect the therapeutic gain of EMDR and CBT.

Interestingly, the GPE shows significant effects for the additional psychological treatment

after TRT in both treatment groups, revealing substantial added value of EMDR and CBT.

Furthermore, after the TRT counseling more than 60% of the patients reported

improvement, whereas more than 80% expressed significant decrease of tinnitus

complaints after psychotherapeutic treatment. These self-perceived ameliorations were

confirmed by the tinnitus questionnaires. In 46% of the patients who received TRT and

CBT, a clinically significant effect in TFI was observed (i.e. a decrease of 13 points or more

on the total score) and 33% reported improvement on the tinnitus-related subscales

resulting in a total of 79% who experienced positive changes. In the TRT / EMDR treatment

group, 35% described some improvement and 53% declared clinically significant tinnitus

relief, in sum 88% feeling less tinnitus distress. Comparable percentages were found on

the TQ.

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The mean decrease of TFI scores on the different subscales did not reveal a significant

effect of treatment as there was a significant decrease on every subscale in both bimodal

therapies, except for the subscale ‘Sleep Disturbances’ after TRT/CBT and the subscale

‘Auditory Difficulties’ in both treatment groups.

Overall, both bimodal therapies resulted in significant reduction of tinnitus distress, tinnitus

related complaints, tinnitus loudness, hypersensitivity to sound, anxiety, and depressive

symptoms and led to significant increase of quality of life. Assessments indicated a stable

effect of these improvements after three months. Seemingly, the ratings provided by

patients on the TFI, TQ and GPE showed good agreement.

The scope of this study was limited by lack of tinnitus measurements after the TRT

sessions since no conclusions can be drawn from which specific interventions resulted in

the significant decrease of tinnitus complaints. However, previous research indicates that

the combinational therapies containing educational tinnitus counseling and CBT lead to

better therapeutic outcome compared to unimodal therapy (Seydel, Haupt et al. 2010,

Cima, Maes et al. 2012, Fuller, Haider et al. 2017).

One of the most significant findings to emerge from this study is that the bimodal therapy

of TRT / EMDR shows equivalent effects in comparison to the bimodal TRT / CBT therapy

in the treatment of chronic, subjective tinnitus. The present study provides the first

comprehensive assessment of subjective and objective outcome measurements in

psychotherapeutic treatment for tinnitus in a considerable and representative sample size.

The drop-out rate was lower than expected, indicating motivated patients and the

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installation of positive therapeutic alliances. Moreover, a strong significant therapeutic

effect was detectable in both therapy arms and it would have been challenging to

significantly transcend the obtained improvement by one or the other bimodal treatment.

The present study was designed to assess whether a bimodal therapy for chronic

subjective tinnitus consisting of the combination of TRT and EMDR results in a clinically

significant different efficacy in comparison with the prevailing bimodal TRT and CBT

therapy. These empirical findings highlight the effectiveness of both bimodal therapies

showing no different efficacy after assessment with multiple tinnitus self-report

questionnaires. This research project on the implementation of bimodal therapy as

treatment for tinnitus adds to the growing body of research that draws attention to the

effectivity of common factors in psychotherapeutic treatment, the importance of the

therapeutic alliance and the influence of personality traits.

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PART III INFLUENCING FACTORS IN TINNITUS TREATMENT

To investigate the influence of specific personality traits in therapeutic outcome, data from

the RCT were employed to identify correlations between self-report outcome measures

and Big Five Inventory (BFI) personality traits and facets. Chapter 4 discusses this

prospective analysis, performed on the data of 82 tinnitus patients treated with TRT/CBT

and TRT/EMDR. A multiple regression analysis and a k-means cluster analysis were

conducted providing interesting findings.

High Extraversion was significantly linked to low levels of tinnitus distress at baseline (p<

0.05). Consistency was found in previous research where low Extraversion was

associated with higher levels of tinnitus distress (Durai and Searchfield 2016). Our main

interest was in the influence of personality on treatment outcome. First of all, no significant

differences were found for BFI-traits and therapy group (i.e. TRT/EMDR vs TRT/CBT). In

general, in this study no significant correlations were found for Open-Mindedness, and

this contrasts with research conducted by Kleinstäuber et al. (2018) who showed that

Open-Mindedness predicted lower tinnitus complaints after treatment by internet-based

CBT (ICBT). Furthermore, the study of Simões, Schlee et al. (2019) presented that

improvement over time was correlated with higher Extraversion. Our findings indicated a

similar trend for Extraversion and Open-Mindedness, but no significant correlations could

be defined. However, in agreement with former studies, high scores on the factor Negative

Emotionality significantly correlated negatively with lower decrease of TFI-scores,

demonstrating lesser improvement for patients with higher Negative Emotionality (p <

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0.01). This was the first study to reveal that high Conscientiousness (p < 0.01) significantly

predicted lower therapeutic response.

K-means cluster analysis revealed four distinct personality clusters containing a specific

combination of traits. Patients in cluster 1 appeared to improve significantly after the

bimodal therapy compared to patients in cluster 2 (p < 0.01) and cluster 4 (p < 0.05). The

highest therapeutic gain was retrieved in cluster 1, which resembles cluster 4 for almost

all the personality traits with the exception of the trait Conscientiousness. The specific

mixture of traits in cluster 2 shows great overlap with the Type-D personality (i.e.

‘distressed’ personality) (TDP), consisting of high levels of Negative Emotionality and low

levels of Extraversion, Agreeableness, and Conscientiousness (De Fruyt and Denollet

2002). Evidence indicates that TDP is associated with depressive and anxiety symptoms,

as well as PTSD and therefore has an increased risk for developing medical and

psychiatric disorders (Denollet 2000, Habra, Linden et al. 2003, Kim, Stewart et al. 2016).

Given the fact that patients in cluster 2 present a psychopathological condition, a more

intensive therapeutic trajectory might be needed. The combination of specific facets

seems to influence the level of improvement after psychological treatments. More research

is required to develop more comprehension of the impact of individual patient

characteristics in tinnitus treatment.

In conclusion, this study provides evidence for the substantial role of Conscientiousness

and Negative Emotionality, both significantly predicting TFI scores at baseline and a

significant decrease in TFI scores after psychotherapeutic treatment. The findings reported

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here shed a new light on the association of personality traits and the perception of tinnitus

sounds, the related tinnitus distress and consequently the influence on treatment

outcome. This prospective study has revealed that the personality traits

Conscientiousness and Negative Emotionality offer predictive and appended value in the

field of tinnitus management. This study may help develop therapeutic trajectories

according to cluster membership to improve psychological health and decrease tinnitus

related complaints.

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FUTURE PERSPECTIVES

CHAPTER SEVEN

FUTURE

7 PERSPECTIVES

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7. FUTURE PERSPECTIVES

The randomized controlled trial conducted in this doctoral thesis makes several

contributions to our current knowledge of psychotherapeutic interventions in the treatment

of chronic subjective tinnitus. Still, several questions remain to be answered and are in

need of further investigation. The findings of this study provide a number of important

implications and future perspectives.

STUDY DESIGN AND OUTCOME MEASURES

Despite careful consideration of the proposed study protocol, objective evidence for the

added value of EMDR and CBT is lacking. This study has focused on only two forms of

bimodal psychotherapeutic treatment. Therefore, no statements can be made regarding

unimodal therapy (i.e. TRT or CBT or EMDR). Previous research has provided evidence

for a superior effect of CBT over TRT (i.e. (Cohen’s d = 0.75)) (Westin, Schulin et al. 2011).

Nevertheless, future studies might include a TRT-condition to investigate whether CBT

and EMDR prevail TRT. Even so, the GPE expressed by the patients did provide valuable

information about the subjectively experienced improvement and perceived decrease of

tinnitus complaints.

One could state that including a control group or sham-group might have provided

necessary data to make definite conclusions. The decision to not include a sham – group

was based on deontological and ethical reasons. For some patients who had been

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searching for years to find effective treatment, it would have been unethical to abstain

them from actual treatment as the demographic data clearly demonstrated considerable

tinnitus burden. In this manner the high risk for drop-out was reduced as substantial tinnitus

distress encourages patients to keep on searching for help elsewhere.

A placebo treatment or sham intervention could be considered in the future, but one might

question if the presence and attention given by a health professional could enhance

several positive influences, such as hope, expectations and reassurance. A waiting list

condition could also induce the same effects. The implementation of a delayed design

could perhaps create opportunities to investigate the effects of the therapeutic

interventions compared to natural decrease of tinnitus distress and related complaints.

However, previous research has not yet revealed spontaneous significant improvement in

delayed designs in the clinical chronic tinnitus population (Michiels, Van de Heyning et al.

2016, Rikkert, Van Rood et al. 2018, Luyten, Van Der Wal et al. 2020). It was reasoned

that the prior concern should always be the well-being of the patient and the focus on

mental and physical resilience. Nonetheless we do recognize the need to develop a

design for an effectivity study where the specific psychological therapies can be

investigated.

Moreover, this study performed tinnitus assessment at three time points. Stable effects

could be detected after three months. However, no conclusions can be made on long-

term improvement in this study. It would be interesting to assess the evolution of the

patients after 6, 12 or 18 months.

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Furthermore, the effectiveness of both therapies might also be partly explained by

common factors. Previous research on psychotherapeutic treatment indicated that not

only specific therapy techniques, but also expectancy effects, therapeutic factors, and

common factors have an influence on client outcome. It has been demonstrated that

common factors such as empathy, congruence, unconditional positive regard, and the

therapeutic alliance correlate more highly with client outcome than specialized treatments

(Lambert 2016, Cuijpers, Reijnders et al. 2019). Even more, there is growing evidence

that the ‘therapist -effect’ determines more of the therapeutic outcome than the specific

psychotherapeutic intervention (Norcross and Lambert 2019, Hafkenscheid 2020).

Therefore, we postulate the hypothesis that the therapeutic alliance is one of the main

impacting factors in psychological treatment for tinnitus. Associations have been found

between attachment styles on the one hand, and tinnitus distress and tinnitus-related

problems on the other. Granqvist, Lantto et al. (2001) found that an avoidant attachment

style was related to tinnitus-related problems in contrast to a secure attachment. This

attachment style affects the installation of the therapeutic relationship. We hypothesize

when a positive therapeutic alliance is built, a higher level of improvement can be reached.

Evidence underlines the relationship between therapeutic alliance and treatment outcome

in various diagnoses (Joyce and Piper 1998, Krupnick, Sotsky et al. 2006, Horvath, Del

Re et al. 2011), and so it might be valuable to discover whether this alliance is a significant

mediating factor in tinnitus treatment. Assessments could be employed to investigate

whether these variables effect therapy outcome in the tinnitus population compared to

current tinnitus questionnaires. Additionally, we speculate that current self-report tinnitus

questionnaires do not always display the true therapeutic gain. Certain behavioural

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changes, occurrence of specific life events, life satisfaction in the areas of health, self-

esteem, goals and values, money, work, play, learning, creativity, helping, love, friends,

children, relatives, home, neighborhood, and community, might be interesting to assess

in order to develop more understanding of what is actually leading to decrease in tinnitus

related distress and associated life domains.

GENDER DIFFERENCES

The explorative gender study (Luyten, Van Der Wal et al. 2020), conducted after this

doctoral research, investigated gender effects on treatment outcome in TRT/CBT,

TRT/EMDR, high-definition transcranial direct current stimulation (HDtDCS), and physical

therapy treatment. In general, the results indicated that gender could be an influential factor

in treatment outcome.

For the TRT/CBT and TRT/EMDR study population, analyses revealed that male patients

experienced substantial more benefit than females from TRT/CBT, while both males and

females reported significant improvement as a result of the combination of TRT and EMDR

therapy. However, these findings should be interpreted with caution as 70% of the female

patients suffered from a psychiatric condition. It can be assumed that the presence of a

psychiatric disorder compromises the therapeutic effect and that a therapeutic trajectory

of more than 10 sessions should be recommended to treat the comorbid and maintaining

factors associated with the tinnitus complaints. Some evidence can be found on the

specific problem-focused interventions, integrated in the CBT approach, to show more

improvement in males compared to females, who tend to experience more improvement

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through an emotion-focused treatment (Ogrodniczuk, Piper et al. 2001, Matud 2004,

Ogrodniczuk 2006, Meléndez, Mayordomo et al. 2012).

Evidence on gender effects and the efficacy of psychological tinnitus treatments is scarce.

Prospective trials, with a large and gender balanced sample size are needed to confirm

the gender effects we discussed. Future research might focus on finding more evidence

on the impact of the gender differences and psychiatric comorbidity that affect the

therapeutic pathway and treatment outcome.

PERSONALITY TRAITS

The BFI-II analysis revealed a significant correlation between the decrease in TFI scores

and high scores on the factor Conscientiousness. This outcome was contrary to that of

previous research on ICBT in tinnitus treatment concluding that high scores on the factor

Conscientiousness predicted favorable treatment outcome (Kleinstäuber, Weise et al.

2018). We speculated that this might be due to the implication of the specific treatment

method. An internet-based approach might elicit the sense of responsibility for the

treatment outcome for persons with high levels of Conscientiousness and enhance

engagement to one’s self (Kleinstäuber, Weise et al. 2018). Conscientiousness is known

to be related to the will for achievement and commitment to work (Costa Jr, McCrae et al.

1991). Therefore, this personality trait could stimulate coping behavior to complete an

ICBT program.

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The prospective analysis conducted in this doctoral thesis gathered evidence for four

distinct personality clusters. Cluster 1 was associated with a significant mean decrease of

26,52 points on the TFI and differed significantly from cluster 2, gaining less therapeutic

improvement with a mean decrease of 11,63 points. Remarkably, both clusters presented

low levels of Conscientiousness. The most important trait that differed between these

clusters was the factor Open-Mindedness. The other cluster that showed less

improvement (i.e. a mean reduction of 14,58 points was cluster 4 containing of high levels

of Conscientiousness in comparison to cluster 1). Seemingly, the combination of traits

influences treatment outcome in different ways.

We hypothesize that lower levels of Conscientiousness may result in maladaptive coping.

Future studies might unravel these speculations. Conscientiousness is found to be

positively related to active coping and negatively correlated to depression and perceived

stress (O'Cleirigh, Ironson et al. 2007). Previous studies on personality types and coping

have presented the combination of high Neuroticism and low Conscientiousness to lead

to high vulnerability to stress and show a passive, dysfunctional, helpless coping style

(Vollrath and Torgersen 2000). This study was built on the clustering of Extraversion (E),

Conscientiousness (C) and Neuroticism (N). A number of 8 personality types were studies

based on Torgerson’s typology (Torgersen and Alnæs 1989). Apparently, the personality

profile in cluster 1 resembles two personality types: ‘the impulsive type’ (i.e. high E, high

N, low C) and ‘the insecure type’ (i.e. low E, high N, low C) (Vollrath and Torgersen 2000).

Evidence was found for an ambiguous role of Extraversion in combination with Neuroticism

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and Conscientiousness. High C, in combination with high E, seemed to decrease the

negative effects of high N, but high E only influenced high N slightly when C was low.

This raises important questions regarding the impact of Conscientiousness and the

implications on future treatment. The combination of traits in the presented clusters seems

to provide more relevant information than one single trait. Research on psychotherapeutic

interventions might therefore focus more on a personality type (i.e. a cluster of personality

traits) associated with specific coping strategies opposed to one distinct trait.

EXECUTIVE FUNCTIONING AND COPING STRATEGIES

The relationship between personality traits and coping strategies has been demonstrated

in previous studies (Attias, Shemesh et al. 1995, Budd and Pugh 1996, Scott and

Lindberg 2000, Durai and Searchfield 2016, Durai, O’Keeffe et al. 2017). The degree of

Conscientiousness and Negative Emotionality in one’s personality might influence the

coping strategies in dealing with tinnitus distress. During treatment a focus on emotion

regulation (e.g. Negative Emotionality) and attention switching (e.g. Conscientiousness)

could therefore stimulate positive self-controlling coping behavior. This hypothesis might

be interesting to investigate in future trials.

In consequence, we assume that participants with lower levels of Conscientiousness,

consisting of the facets Organization, Productiveness and Responsibility, experience

challenges in the area of executive functions. Within psychotherapeutic treatment,

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interventions are integrated to facilitate stress management, organization, focusing, and

attention switching. The relationship between impairment in executive functions in the

prefrontal cortex as important factor for the perseverance of chronic tinnitus is already

been well established in previous research (Vanneste, Van de Heyning et al. 2011,

Vanneste, Joos et al. 2012, Araneda, Renier et al. 2018, Cardon, Jacquemin et al. 2019).

Therefore, patients with low levels of Conscientiousness might benefit more from therapy

where the focus lies on these executive challenges. Moreover, the link between Attention

Deficit Hyperactivity Disorder (ADHD) and the personality trait Conscientiousness has been

discussed in previous research, showing consistent findings of low Conscientiousness in

ADHD (Parker, Majeski et al. 2004, Miller, Miller et al. 2008, Martel 2009).

Conscientiousness could be seen as ‘normal – trait marker’ for the prefrontal mediated

area of executive functioning (Nigg 2001). This relation might offer important implications

for future tinnitus management and further research is warranted.

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FINAL CONSIDERATION

In a world where the input of external and internal stimuli is constantly increasing and the

pressure is on to participate in a high-functioning society consisting of work achievement,

social media profiling, relationship expectancies and development of inner growth and

health, tinnitus patients, in particular, are challenged. All people are in need of focus and

a filter to process all these impressions. For people suffering from tinnitus this filtering

system, or gating mechanism, is disrupted. Given the overflow of sensory stimuli, present

and still to come, tinnitus is becoming a global health problem.

Psychotherapeutic treatment can make a great contribution in gaining more executive

functioning (e.g. ability to filter) and developing skills to cope with this overflow of external

and internal stimuli and associated reactions, thoughts and emotions. So far, no

conclusions can be made on which psychotherapeutic intervention is most

recommended. However, the bimodal therapy TRT/CBT and TRT/EMDR both show

significant therapeutic gain.

Future research should be undertaken to investigate the relationship between specific

interventions, gender differences, personality traits, executive functioning, coping

strategies and treatment outcome on a larger sample size to validate the presented

findings. To develop a full picture of which therapeutic trajectory is most effective for which

patient, additional studies will be needed that map those particular characteristics, and

moreover, explore the therapeutic alliance and process markers during therapy.

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The discussed findings in this doctoral thesis on psychological interventions, are possible

key factors for effectivity in the treatment of tinnitus and provide interesting research

opportunities. As a personal note, I would like to share one of the most reported feedback

given by patients, which was feeling heard and understood throughout the therapy. The

presence of a therapist who genuinely listens and serves as a sounding board, seems to

be a highly important component for effective treatment. The focus for clinicians and

researchers might therefore be redirected to the significance of a listening ear in the tinnitus

treatment. Perhaps the scientific tinnitus field is in need of a filtering system as well. To

conclude, these findings are encouraging in getting closer to finding patient attunement

and directions in the heterogeneous landscape of the tinnitus population.

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APPENDICES LIST OF POTENTIALLY RELEVANT STUDIES

SUMMARY OF TREATMENT PROTOCOL TRT/CBT SUMMARY OF TREATMENT PROTOCOL TRT/EMDR BFI-2 ITEMS SUMMARIZED FROM SOTO AND JOHN (2017)

Appendices

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APPENDIX A: LIST OF POTENTIALLY RELEVANT STUDIES

Database Study-ID Status Format The Francine Case reports Shapiro Library 1. Piffaut, A. M. (2007, June). [EMDR in the treatment of Excluded Conference hypercousy, vertigo, and acouphens. Psychosomatic proceeding ORL]. Presentation at the 8th EMDR Europe Association Conference, Paris, France. French 2. Hingorrany, S. (2017, April). EMDR in treating tinnitus. Excluded Conference In EMDR & illness/medical issues/somatisation proceeding /chronic pain/cancer (Derek Farrell, Chair). Presentation at the 3rd EMDR Asia International Conference, Shanghai, China Observational study 3. Rikkert, M., van Rood, Y., de Roos, C., Ratter, J., & Included Article van den Hout, M. (2018). A trauma-focused approach for patients with tinnitus: The effectiveness of eye movement desensitization and reprocessing - a multicenter pilot trial. European Journal of Psychotraumatology, 9(1512248). doi:10.1080/20008198.2018.1512248 4. Phillips, J. S., Erskine, S., Moore, T., Nunney, I., & Included Article Wright, C. (2019, January). Eye movement desensitization and reprocessing as a treatment for tinnitus. The Laryngoscope. doi:10.1002/lary.27841 5. Zengin, F. (2006). [Treatment of acute hearing loss Excluded Newsletter, and tinnitus with EMDR therapy]. EMDRIA no data Deutschland e.V. Rundbrief, 7, 45-53. German 6. Plassmann, R. (Ed.). (2009). [In our own rhythm, the Excluded Book connection allergy disorders EMDR treatment of eating chapter, no disorders, pain, anxiety disorders, tinnitus and data addictions]. Giessen, Germany: Psychosozial- Verlag. German. Zengin, F. (2009). [Treatment of hearing loss and tinnitus with EMDR therapy]. In R. Plassmann, (Ed.) Im eigenen rhythmus, die EMDR-behandlung von essstrungen, bindungsstrungen, allergien, schmerz, angststrungen, tinnitus und schten (pp. 155-164). Giessen, Germany: Psychosozial-Verlag 7. Luyten, T., Van de Heyning, P., Jacquemin, L., Van Excluded Study Looveren, N., Declau, F., Fransen, E., & Gilles, A. protocol (2019). The value of eye movement desensitization reprocessing in the treatment of tinnitus: Study protocol for a randomized controlled trial. Trials, 20-32 PubMed Experimental studies (MEDLINE) 8. Eye movement desensitization and reprocessing as a Included Article treatment for tinnitus. Phillips JS, Erskine S, Moore T, Nunney I, Wright C.

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Laryngoscope. 2019 Jan 28. doi: 10.1002/lary.27841.

9. A trauma-focused approach for patients with tinnitus: Included Article the effectiveness of eye movement desensitization and reprocessing - a multicentre pilot trial. Rikkert M, van Rood Y, de Roos C, Ratter J, van den Hout M. Eur J Psychotraumatol. 2018 Sep 11;9(1):1512248. doi: 10.1080/20008198.2018.1512248. 10. The value of Eye Movement Desensitization Excluded Study Reprocessing in the treatment of tinnitus: study protocol protocol for a randomized controlled trial. Luyten T, Van de Heyning P, Jacquemin L, Van Looveren N, Declau F, Fransen E, Gilles A. Trials. 2019 Jan 9;20(1):32. doi: 10.1186/s13063- 018-3121-6. The RCT Cochrane Library 11. The value of EMDR in the treatment of tinnitus Excluded Study NCT03114878 protocol Https://clinicaltrials.gov/show/nct03114878, 2016 | added to CENTRAL: 31 May 2017 | 2017 Issue 5 12. The value of Eye Movement Desensitization Excluded Study Reprocessing in the treatment of tinnitus: study protocol protocol for a randomized controlled trial T Luyten, P Van De Heyning, L Jacquemin, N Van Looveren, F Declau, E Fransen, A Gilles Trials, 2019, 20(1) | added to CENTRAL: 31 March 2019 | 2019 Issue 3 PSYNDEX Experimental studies 13. Zengin, F. (2009). [Treatment of hearing loss and Excluded Book tinnitus with EMDR therapy]. In R. Plassmann, (Ed.) Im chapter eigenen rhythmus, die EMDR-behandlung von essstrungen, bindungsstrungen, allergien, schmerz, angststrungen, tinnitus und schten (pp. 155-164). Giessen, Germany: Psychosozial-Verlag 14. A trauma-focused approach for patients with tinnitus: Included Article the effectiveness of eye movement desensitization and reprocessing - a multicentre pilot trial. Rikkert M, van Rood Y, de Roos C, Ratter J, van den Hout M. Eur J Psychotraumatol. 2018 Sep 11;9(1):1512248. doi: 10.1080/20008198.2018.1512248. PsycINFO No studies found Additional Handsearching reference list records 15. Phillips JS. EMDR for tinnitus. Paper presented at: Excluded Conference 29th Politzer Society Meeting; 2013; Antalya, Turkey proceeding 16. Google Een Pilot: EMDR bij tinnitus Kruit, J. Jaarsymposium Excluded Conference search Wetenschappelijke activiteiten Yulius, Hendrik Ido proceeding Ambacht, 14 maart 2016

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APPENDIX B SUMMARY OF TREATMENT PROTOCOL

TRT/CBT

Bimodal therapy TRT / CBT

Psychological intake Performed by a clinical psychologist (60 min)

o Patient history o Assessment of complaints associated with tinnitus and comorbidities o Questions about important life events o Current coping strategies o Questions about previous treatment

TRT Performed by a clinical audiologist and certified TRT-therapist (accompanied by a PowerPoint presentation)

Session 1 (60 min)

• Assessment of tinnitus complaints • Assessment of present audiologic support (hearing aids if necessary, sound enrichment) if present • Start tinnitus counseling: an explanation of the anatomy and physiology of the normal and impaired auditory system

Session 2 (60 min)

• Continuation of the counseling: role of the central auditory system and higher cortical processes, sensory contrast, selective perception of sensory information

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Session 3 (60 min)

• Continuation of the counseling: an explanation of the neurophysiological model of tinnitus by Jastreboff, illustrate the importance of the activation of subcortical, limbic and automatic nervous systems in tinnitus

Session 4 (60 min)

• Explanation of the importance of sound enrichment, startup of sound generators (bilateral) and clarification about the use

Session 5 (60 min)

• Evaluation of the hearing aids, sound generator, sound enrichment* • Recapitulation of the tinnitus – specific psychoeducation • Handouts of the TRT counseling with personal notes and tips and tricks to cope, information about stress reduction, relaxation exercises, sleep hygiene, concentration and hearing tips

CBT Performed by a certified clinical psychologist and psychotherapist in cognitive behavioral therapy (accompanied by a PowerPoint presentation; based on the CBT treatment outline by Dr. Aazh from the Tinnitus & hyperacusis master class in 2013, Birckbeck College, London)

Session 1 (60 min)

• Education about the auditory system and psychoeducation (brief, only if necessary) • Introduction of CBT and assess the motivation and commitment towards the therapy • Counseling and identification of thoughts, emotions, and behavior to the tinnitus sound using the ABC-model • Create time and space to focus on personal concerns and give reassurance (every session)

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Session 2 (60 min)

• Counseling and identification of negative automatic thoughts and core belief • Educating about common distortions in thinking: all or nothing thinking, overgeneralizing, mental filter, disqualifying the positive, jumping to conclusions, mind reading/fortune-telling, catastrophizing and minimization, emotional reasoning, should/must statement, labeling, personalization

Session 3 (60 min)

• Counseling about challenging unhelpful thoughts, errors of judgment and creating counterstatements • Cognitive restructuring

Session 4 (60 min)

• Evaluate the experiences of the patient as a consequence of helpful thoughts • Behavioral desensitization and graded exposure: specified to be integrated into the patient's life

Session 5 (60 min)

• Evaluate the therapy process and progress* • Focus on positive changes and possible future perspectives • Identify challenges and helpful coping strategies, depending on the patients’ needs focus on elements of mindfulness, acceptance and commitment therapy, relaxation techniques

*Follow – up was organized if necessary (telephone contact, supporting e-mail contact or an extra appointment for fitting or adapting the hearing aids).

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APPENDIX C SUMMARY OF TREATMENT PROTOCOL

TRT/EMDR

Bimodal therapy TRT/EMDR

Psychological intake Identical to bimodal therapy TRT/EMDR

TRT Identical to bimodal therapy TRT/EMDR

EMDR Performed by a certified clinical psychologist and Europe Practitioner psychotherapist in Eye Movement Desensitization and Reprocessing, phases were adapted according to the EMDR protocol of Shapiro and the pace and needs of the patient

Session 1 (60 min)

• Phase 1: Client history: identifying the negative thoughts, sensations, and experiences associated with the tinnitus complaints • Phase 2: Preparation phase: assessment of the stability of the patient, (if the patient was not stable, stabilization techniques were applied), installation of the calm or safe place (use of slow bilateral stimuli), secure a stop sign for when the patient wanted to stop the desensitization process • Create time and space to focus on personal concerns and give reassurance (every session) • Phase 3: Assessment phase: the following elements were made salient: target issue, memory, event or symptom associated with the tinnitus, target image, negative cognition (NC), positive cognition, Validity of Cognition (VoC) on a scale of 1 - 7, emotions, location of bodily sensation, Subjective Units of Distress (Oishi, Yamada et al.) on a scale of 0 – 10

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Session 2 (60 min)

• Reevaluation of the previous session Recapitulate phase 3 • Phase 4: Desensitization phase: focus on the target image, negative cognition and bodily sensation, set of bilateral stimuli = BLS (visual or tactile) as fast as the patient can tolerate, after each set the therapist asked the question “What do you get now?, What are you noticing?”, if the patient reports new material “Go with that.”, after the patient reported two consecutive times positive material (= desensitization), phase 5- 6-7 was started • If phase 4 was not completed at the end of the session, the therapist ensured stabilization before leaving the private practice according to the standard protocol; discussion of what can appear after the session

Session 3 (60 min)

• Reevaluation of the previous session • Recapitulate phase 3 and phase 4: perform BLS until desensitization was reached • Phase 5: Installation phase: check PC “Do the words PC still fit, or would another positive statement be more suitable?”, and VoC “Think about the original incident and the words PC. How true do they feel now (1-7)?” • The patient was asked to focus on the target incident and the PC, followed by completion of sets of BLS until there was no change • Phase 6: Body scan: the patient was asked to mentally scan the entire body and report this to the therapist • Phase 7: Closure: check of feelings and sensations of the patient; identification of the gain of the session and discussion of what can appear after the session

Session 4 (60 min)

• Phase 8: Reevaluation of the previous session: *the patient assesses the results and experiences since the previous session • Recurrence of phase 3 – phase 7 when other targets were associated with the tinnitus complaints

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Session 5 (60 min)

• Phase 8: Reevaluation of the previous session* • Recurrence of phase 3 – phase 7 when other targets were associated with the tinnitus complaints

*Follow – up was organized if necessary (telephone contact, supporting e-mail contact or an extra appointment for fitting or adapting the hearing aids).

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APPENDIX D BFI – 2 ITEMS

Personality traits Specific facet traits Items

Extraversion

Sociability Tends to be quiet. Is talkative. Is outgoing, sociable. Is sometimes shy, introverted.

Assertiveness Is dominant, acts as a leader. Has an assertive personality. Prefers to have others take charge. Finds it hard to influence people.

Energy Level Is full of energy. Shows a lot of enthusiasm. Rarely feels excited or eager. Is less active than other people.

Agreeableness

Compassion Is compassionate, has a soft heart. Can be cold and uncaring. Is helpful and unselfish with others. Feels little sympathy for others.

Respectfulness Is respectful, treats others with respect. Is polite, courteous to others. Is sometimes rude to others. Starts arguments with others.

Trust Assumes the best about people. Has a forgiving nature. Tends to find fault with others. Is suspicious of others’ intentions.

Conscientiousness

Organization Tends to be disorganized. Is systematic, likes to keep things in order. Keeps things neat and tidy. Leaves a mess, doesn’t clean up.

Productiveness Is efficient, gets things done. Is persistent, works until the task is finished. Tends to be lazy. Has difficulty getting started on tasks.

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Responsibility Can be somewhat careless. Sometimes behaves irresponsibly. Is reliable, can always be counted on. Is dependable, steady.

Negative Emotionality

Anxiety Is relaxed, handles stress well. Worries a lot. Rarely feels anxious or afraid. Can be tense.

Depression Often feels sad. Tends to feel depressed, blue. Feels secure, comfortable with self. Stays optimistic after experiencing a setback.

Emotional Volatility Is emotionally stable, not easily upset. Is temperamental, gets emotional easily. Keeps their emotions under control. Is moody, has up and down mood swings.

Open-Mindedness

Intellectual Curiosity Has little interest in abstract ideas. Is complex, a deep thinker. Avoids intellectual, philosophical discussions. Is curious about many different things.

Aesthetic Sensitivity Is fascinated by art, music, or literature. Has few artistic interests. Values art and beauty. Thinks poetry and plays are boring.

Creative Imagination Has little creativity. Is inventive, finds clever ways to do things. Is original, comes up with new ideas. Has difficulty imagining things.

NOTE: BFI-2 ITEMS SUMMARIZED FROM SOTO AND JOHN 2017

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245

147260 Luyten BNW.indd 243 22-12-2020 13:55 147260 Luyten BNW.indd 244 22-12-2020 13:55 CURRICULUM VITAE

CURRICULUM VITAE

Tine Luyten was born in 1980 in Strathroy, a small town in Canada. At the age of 4, she moved to

Belgium with her family. Here she started her secondary education (Latin – Modern Languages) in

1992 at Sint – Claracollege in Arendonk, Belgium. After 4 years of studying Latin, her interest in

psychology and social sciences expanded. For this reason, she continued her secondary education

at Sint – Pietersinstituut in Turnhout, Belgium to study human sciences. In 2001 she graduated with

honors from Lessius Hogeschool (Thomas More, Antwerp, Belgium) in Social Agogic work, namely

with a professional bachelor’s in applied Psychology. After building up experience in the field of

mental health, she started her Master of Science in Psychology (Catholic University of Leuven),

served an internship at Pontificia Universidad Catholica del Peru and graduated cum laude in 2011.

Because therapeutic work had always been her passion, she combined working in a private practice

and completing a 4 – year postgraduate training in Psychotherapy, the Integrative training in

experiential and cognitive behavioral therapy at the University of Antwerp, Belgium. Meanwhile she

began to specialize in the treatment of tinnitus and hyperacusis. The Tinnitus & hyperacusis

masterclass at the University of London, UK (2013 and 2019), helped her to support her patients in

need. To extend her therapeutic skills, she completed the training to become an EMDR practitioner

at Integrativa, Aalst, Belgium.

As scientific research had always stimulated her to analyze and explore the complexity of the human

brain and psychotherapy, she came in contact with Prof. dr. Paul Van de Heyning. This encounter

led to the development of a research project that was financially supported by VLAIO. Thanks to this

grant she was able to conduct a randomized controlled trial and submit this dissertation.

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147260 Luyten BNW.indd 246 22-12-2020 13:55 LIST OF PUBLICATIONS

LIST OF PUBLICATIONS

• Luyten, T., Gilles, A., Jacquemin, L., Van Looveren, N., Declau, F., Fransen, E., & Van de Heyning, P. 2017. The value of Eye Movement Desensitization Reprocessing in the treatment of tinnitus. Journal of Hearing Science, 7(2).

• Luyten, T., Van de Heyning, P., Jacquemin, L., Van Looveren, N., Declau, F., Fransen, E., & Gilles, A. 2019. The value of Eye Movement Desensitization Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial. Trials, 20(1), 32.

• Luyten, T. & Van der Wal, A. & Cardon, E., Jacquemin, L., Vanderveken, O., Topsakal, V., Van de Heyning, P., De Hertogh, W., Van Looveren, N., Van Rompaey, V., Michiels, S. & Gilles, A. 2020. Sex differences in the response to different tinnitus treatment. Frontiers in Neuroscience, 14, 422.

• Luyten, T., Van Rompaey, V., Van de Heyning, P., Van Looveren, N., Jacquemin, L., Cardon, E., Declau F., Fransen, E., De Bodt, M., & Gilles, A. 2020. Eye Movement Desensitization Reprocessing in the treatment of chronic subjective tinnitus: A Systematic Review. Journal of EMDR Practice and Research, Volume 4, Number 3, 135-149.

• Luyten, T. & Jacquemin, L, Van Looveren, N., Cardon, E., Fransen, E., Topsakal, V., Declau, F., De Bodt, M., Van de Heyning, P., Van Rompaey, V., & Gilles, A., 2020. Bimodal therapy for subjective, chronic tinnitus: a randomized controlled trial of EMDR and TRT versus CBT and TRT. Frontiers in Psychology, 11, 2048.

249

147260 Luyten BNW.indd 247 22-12-2020 13:55 LIST OF PUBLICATIONS

• Luyten, T., Cardon, E., Jacquemin, L, Van Looveren, N., Fransen, E., Topsakal, V., Declau, F., De Bodt, M., Van de Heyning, P., Van Rompaey, V., & Gilles, A., 2020. The influence of personality traits in the psychotherapeutic treatment of chronic tinnitus. Under review in Journal of Psychosomatic Research.

• Luyten, T., Cardon, E., Jacquemin, L, Van Looveren, N., Fransen, E., Topsakal, V., Declau, F., De Bodt, M., Van de Heyning, P., Van Rompaey, V., & Gilles, A., 2020. Event Related Potentials as objective measures in the psychotherapeutic treatment of chronic tinnitus. In preparation.

250

147260 Luyten BNW.indd 248 22-12-2020 13:55 ATTENDED CONFERENCES

ATTENDED CONFERENCES

• Symposium: the treatment of tinnitus

Artevelde Hogeschool, 25/04/2013, Ghent, Belgium

• Conference ‘Tinnitus: science and clinical practice’

B-Audio, Catholic University Leuven, 26/04/2014, Brussels, Belgium

• 2nd International Conference on Hyperacusis

Birkbeck College University of London, 9-10/07/2015, London, UK

• TRI/TINNET Conference 2018

Tinnitus Research Center, 14-16/03/2018, Regensburg, Germany

• TRI Conference 2019 / Cross-Strait Tinnitus Seminar

NTUH International Convention Center, 17-19/05/2019, Taipei, Taiwan

• 4th International Conference on Hyperacusis

Birkbeck College University of London, 11/07/2019, London, UK

à TRI Conference 2020 / Pre-conference Workshops

20-23/05/2020, Vancouver, Canada: cancelled due to the COVID-19 pandemic

à 5th International Conference on Hyperacusis

16-17/07/2020, Birkbeck college, University of London: cancelled due to the

COVID-19 pandemic

• Conference ‘Audiology in its broadest sense’

B-Audio and NVA, 20/11/2020, Joint Virtual Congress

251

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• Symposium: Behandeling en counseling bij tinnitus

Artevelde Hogeschool, 8/12/2020, online studiedag

• Research day EMDR-Belgium: the effect of EMDR on trauma/stress-

related complaints, 12/12/2020, online studiedag

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147260 Luyten BNW.indd 250 22-12-2020 13:55 PRESENTATIONS

PRESENTATIONS

• Tinnitus treatment by bilateral stimulation: development study protocol.

Intercollegiaal overleg, 07/11/2014, 05/12/2014, 21/01/2015, 18/01/2016, UZA,

Edegem, Antwerp

• Tinnitus treatment by bilateral stimulation: submission research project.

Oral presentation, 21/03/2016, VLAIO, Brussels, Belgium

• Bimodal therapy in the treatment of tinnitus.

Intercollegiaal overleg, 01/07/2016, 07/11/2016, 05/04/2017, UZA, Edegem,

Antwerp

• The value of Eye Movement Desensitization Reprocessing in the treatment of

tinnitus:

interim analysis and planning research project.

Intercollegiaal overleg, 22/08/2017, 07/11/2017, 07/02/2018, UZA, Edegem,

Antwerp

• The value of Eye Movement Desensitization Reprocessing in the treatment of

tinnitus. Poster presentation, 22 – 24/05/2017, TRI 2017, Warschau, Poland

• The value of Eye Movement Desensitization Reprocessing in the treatment of

tinnitus.

Oral Presentation, 14 – 16/03/2018, TRI 2018, Regensburg, Germany

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• Study protocol of a randomized controlled trial. The value of EMDR in the treatment

of tinnitus.

Oral presentation, 26/03/2019, NKO - Sint-Vincentiusziekenhuis, Antwerp, Belgium

• The value of Eye Movement Desensitization Reprocessing in the treatment of

tinnitus.

Poster presentation, 17-19/05/2019, TRI Conference 2019 / Cross-Strait Tinnitus

Seminar, NTUH International Convention Center, Taipei, Taiwan

• Psychotherapeutic interventions in the treatment of chronic, subjective tinnitus.

Oral presentation 13/06/2019, Doctoral Evaluation Commission, UA, Wilrijk, Belgium

• EMDR as treatment for chronic tinnitus: practical implementation and case study.

Presentatie en Intercollegiaal overleg, 04/07/2019, UZA, Edegem, Antwerp

• Cognitive behavioral therapy or EMDR? Results of a randomized controlled trial.

Oral presentation 21/10/2019, UZA, Edegem, Antwerp

The influence of personality traits in the psychotherapeutic treatment of chronic tinnitus.

Oral presentation, 20-23/05/2020, TRI Conference 2020 / Pre-conference Workshops,

Vancouver, Canada: cancelled due to the COVID-19 pandemic

Bimodal therapy for subjective, chronic tinnitus: a randomized controlled trial of EMDR

and TRT versus CBT and TRT.

Oral presentation, 20-23/05/2020, TRI Conference 2020 / Pre-conference Workshops,

Vancouver, Canada: cancelled due to the COVID-19 pandemic

254

147260 Luyten BNW.indd 252 22-12-2020 13:55 TRAINING & COURSES

TRAINING & COURSES

• Tinnitus and Hyperacusis Therapy Masterclass

Birkbeck College University of London, 4-8/03/2013, London, UK

• Tinnitus and Hyperacusis Therapy Masterclass

Birkbeck College University of London, 8-10/07/2019, London, UK

• Practitioner EMDR level 1

Integrativa, 9-12/09/2014, Aalst, Belgium

• Practitioner EMDR level 2

Integrativa, 6-8/05/2015, Aalst, Belgium

• Postgraduate of Psychotherapy. Integrative training in experiential and cognitive

behavioral therapy, Study load of 85 credits

University of Antwerp, 2013 – 2018, Wilrijk, Antwerp

o Client-centered-experiential Psychotherapy (part 1, 2, 3 and 4)

o Cognitive Behavioral Therapy (part 1, 2, 3 and 4)

o The Practice of Psychotherapy and Supervision (part 1, 2, 3 and 4)

o Learning Therapy, Reflection, Integration and Self Evaluation

(part 1, 2, 3 and 4)

o Specialization Report (part 1 and 2): Title thesis: Fragile. Handle with

care. The therapeutic relationship in the treatment of a fragile process.

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Active memberships:

§ International Organizing Committee + Scientific Committee International Hyperacusis

Conference (IHC)

§ International Clinical Expert Group (CEG)

§ EMDR Belgium + EMDR Europe Practitioner

§ Vlaamse Vereniging Klinisch Psychologen (VVKP)

§ Compsy – Psychologencommissie

§ Belgische Federatie van Psychologen (BFP)

§ Beroepsvereniging voor Wetenschappelijk onderbouwde Psychotherapie (BWP)

§ Vlaamse Vereniging voor Cliëntgericht – Experiëntiële Psychotherapie en Counseling

(VVCEPC)

256

147260 Luyten BNW.indd 254 22-12-2020 13:55 DANKWOORD

DANKWOORD

Dit doctoraat is het resultaat van een leerrijk, fascinerend, uitdagend en waardevol

parcours dat ik de voorbije jaren heb afgelegd. Het was geen rechte lijn naar de finish,

maar een traject met snelwegen, zijweggetjes, kronkelpaden, mooie vergezichten,

obstakels en hoogtes en laagtes. Gelukkig hebben enkele ervaren supervisoren me

doorheen het academische landschap gegidst. Vertrouwde en nieuwe reisgezellen

hebben me geholpen en gesteund om uiteindelijk op deze bestemming aan te komen.

Deze reis had ik nooit alleen kunnen en willen maken. De doctoraatsopleiding en het

doctoraatsonderzoek hebben me nog meer de waarde doen ontdekken van

samenwerken, hulp durven vragen en het verbinden met anderen.

Vooreerst wil ik graag Prof. dr. Van de Heyning bedanken voor zijn geloof en vertrouwen

in mij. Van bij de start zorgden zijn enthousiaste en zelfverzekerde reacties voor een

groeiend vertrouwen in mezelf. Ik herinner me nog goed dat ik hem bij onze eerste

ontmoeting vroeg of het combineren van een doctoraat, een psychotherapieopleiding en

de klinische praktijk niet teveel zou zijn. Hij antwoordde “nee hoor, dat zijn drie vliegen in

één klap”. Wat we toen nog niet wisten is dat er in dezelfde periode enkele belangrijke

levensgebeurtenissen op mijn pad zouden komen: een zwangerschap, een prachtige

dochter, een totaalrenovatie van ons droomhuis, gevolgd door een woningbrand, een

nieuwe totaalrenovatie van datzelfde droomhuis, een tweede zwangerschap, een tweede

prachtige dochter en een verhuis. Bedankt voor al uw ondersteuning tijdens deze woelige

jaren.

257

147260 Luyten BNW.indd 255 22-12-2020 13:55 DANKWOORD

U was één van de eersten die steun betuigde toen u het nieuws van de brand op ATV

gezien had. Telkens toen ik vertelde in blijde verwachting te zijn, was u oprecht blij voor

me zonder me te herinneren aan al het doctoraatswerk dat nog moest gebeuren. Dat u

een echte familieman bent, heb ik mogen ontdekken toen u als trotse grootvader foto’s

van uw kleinkinderen toonde en levendig vertelde over de dagelijkse poppenkastshow

voor hen tijdens de lockdown. Ik heb u leren kennen als een man met een groot hart die

het verschil heeft gemaakt voor de maatschappij, ziekenhuizen, universiteiten,

onderzoekers, collega's en studenten. Wat ben ik dankbaar u te mogen kennen!

Prof. dr. Gilles, Annick, wat ben ik gezegend met jou als supervisor! Jij bent mijn steun

geweest van bij de start en haalde de VLAIO-beurs mee binnen waardoor dit

onderzoeksproject werkelijkheid werd. Zonder jou had ik hier niet gestaan. Je hebt me

geholpen en gesteund waar je kon, bij het maken van academische posters,

wetenschappelijke publicaties, presentaties tot het voorzien van noodmedicatie bij de

vermoedelijke voedselvergiftiging op het TRI congres in Taipei. Je wist me ook steeds

gerust te stellen wanneer ik even twijfelde. Jouw enthousiasme, energie en vertrouwen

werken aanstekelijk. You leave a spark wherever you go! Met andere woorden, je was

onmisbaar voor mij. Tijdens de voorbije jaren was je een vertrouwenspersoon, begeleider

en supervisor die uitblinkt in echtheid en empathie. Een topmadam met een gouden hart!

Prof. dr. Frank Declau, zonder u was er helemaal geen sprake geweest van dit doctoraat.

Van bij de start maakte u tijd vrij om mee te brainstormen over het onderzoeksontwerp,

hypothesen en mogelijke verklaringen. De gezellige lunchvergaderingen in de 22B, de

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aanmoedigende gesprekken en kansen die u me gegeven heeft, zal ik nooit vergeten.

Bedankt voor uw steun en uw waardevolle feedback.

Prof. dr. Marc De Bodt, u wil ik hartelijk bedanken voor uw steun, wijze raad en

luisterbereidheid. Op de meest onvoorziene momenten nam u de tijd om te luisteren en

op een bedachtzame manier bruikbaar advies te verwoorden. Bedankt voor uw

waardevolle feedback en uw steunende aanwezigheid tijdens dit doctoraatsproces.

Een oprechte dankuwel gaat ook naar u, Prof. Vincent Van Rompaey. Bliksemsnel kon je

mij voorzien van feedback, suggesties, literatuur en wetenschappelijke verklaringen.

Daarnaast apprecieer ik jouw collegialiteit enorm. De manier waarop we op een

afgestemde manier patiënten konden bespreken, geeft me een groeiend vertrouwen.

Bedankt!

Prof. Erik Fransen ben ik zeer erkentelijk voor de ondersteuning bij de statistische

verwerking van alle data. Bedankt om mijn gids te zijn binnen het statistische doolhof. Ik

ben er vrij zeker van dat ik hier niet alleen uit was geraakt.

Bedankt ook aan Prof. Vedat Topsakal voor de fijne samenwerking de voorbije jaren. Uw

vertrouwen in mij en in het bijzonder uw steun tijdens de laatste presentatie in het UZA zal

me zeker bijblijven.

Ik wil ook graag de juryleden, Prof. Manuel Morrens en Prof. Olivier Vanderveken,

bedanken voor de kostbare tijd en energie die jullie in dit proefschrift hebben gestoken.

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Bedankt, Prof. Morrens, om me tijdens mijn DEC aan te moedigen om dit onderzoek zowel

vanuit wetenschappelijk oogpunt als vanuit de klinische praktijk te bekijken. Ik ben u, Prof.

Vanderveken, ook enorm dankbaar voor uw geruststellende woorden tijdens onze eerste

ontmoeting. Ze staan in mijn geheugen gegrift.

Prof. David Baguley, I thank you for your warm and enthusiastic response on the invitation

to jury my doctoral trajectory. My sincere gratitude goes to you for your valuable feedback,

encouragement and advice.

Prof. Berthold Langguth, I want to express my gratitude for agreeing to read my dissertation

and your participation in the defense. I highly appreciate your time, effort, expertise and

final feedback on my thesis.

In het bijzonder wil ik ook Kristin Deby bedanken om mijn doctoraatsparcours in goede

banen te leiden. Jij was mijn kompas dat me de juiste richting toonde. Jij bent de persoon

die steevast op een snelle en heldere manier communiceerde en de laatste loodjes wat

lichter heeft gemaakt. Bedankt!

De persoon die een onmisbare rol heeft gespeeld in dit doctoraatsonderzoek is Vic Maes.

Als voorheen Director Business Support van Johnson & Johnson Europe, ben je een

onmisbare schakel geweest bij de ondersteuning en de indiening van het VLAIO-project.

Bedankt, Vic, voor je niet aflatende steun, enthousiasme, expertise, kostbare feedback,

tijd en energie. Je bent van onschatbare waarde geweest in dit onderzoeksproces.

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Lieve Nancy, woorden schieten tekort om uit te drukken hoe dankbaar ik je ben. Je bent

mijn steun en klankbord geweest gedurende het hele proces. Jij weet me op een

hartverwarmende manier uit te dagen, te stimuleren en te doen openbloeien. Jij bent de

lijm die gelijkgestemden samenbrengt en waaruit mooie projecten voortkomen. Ik heb jou

leren kennen als het kloppend hart van een mooie kwaliteitsvolle multidisciplinaire

groepspraktijk. Ik heb enorm veel bewondering voor wat jij al verwezenlijkt hebt. Wat

heerlijk om met jou te mogen samenwerken. Bedankt voor jouw grote bijdrage aan het

onderzoek, het delen van jouw expertise en het mogelijk maken van dit onderzoeksproject.

Bedankt voor dit en nog zoveel meer!

Mijn dankbaarheid gaat ook uit naar mijn andere collega’s van de groepspraktijk. Bedankt

om me vertrouwen te geven, aan te moedigen om dit doctoraat te vervolledigen en vorm

te geven. In het bijzonder wil ik graag Julie, Ellen, Ayesha, Lize en Eva bedanken om

steeds met zoveel interesse te luisteren en me te steunen met bemoedigende en

geruststellende woorden.

Er zou geen sprake geweest zijn van metingen en resultaten zonder jouw impressionante

inzet, Laure. Ik vind het enorm bewonderenswaardig hoe je tonnen werk verzette voor dit

onderzoeksproject en je eigen doctoraat afwerkte. Jouw fijngevoelige zintuigen, sterk

inlevingsvermogen, grote verantwoordelijkheidszin en positiviteit maken van jou een

fantastische collega en sterke therapeut. Bedankt voor jouw torenhoge inzet en

engagement!

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Ik heb een vleugje keldermagie mogen beleven met Emilie. Ik leerde jou kennen in Taipei

als getalenteerde en veelbelovende doctoraatsstudent. Ik was toen al onder de indruk.

Door samen de ERP-analyses te doen heb ik ontdekt hoe hyperintelligent en humoristisch

je bent. Bedankt voor al je hulp bij de dataverwerking en publicaties, de gezellige

momentjes in de kelder en de steeds opbouwende feedback in prachtig verwoorde

zinnen. Jij gaat ongetwijfeld bereiken wat je wil bereiken. Daar twijfel ik geen seconde aan.

Daarnaast ben ik het UZA-onderzoeksteam erg dankbaar voor alle ondersteuning en

praktische opvolging. Griet, Sarah, Annemarie, Iris, Julie en Hanne jullie wil ik heel graag

bedanken voor de fijne gesprekken en hulp. Bedankt om jullie ervaringen en expertise met

me te delen. Hopelijk komen we elkaar in de toekomst nog meer tegen in de praktijk, een

congres of elders.

I would also like to thank the founder, Dr. Hashir Aazh, and other members of the Clinical

Expert Group (CEG), Kristiina Laakso, Dr. Ana Jotic, Jemma Hatton, Jills Kurian, Tarryn

Richardson and Dr. Sandra Bastos, for creating the opportunity to exchange our expertise

and experiences in the implementation of CBT. Thank you Hashir for your excellent

training, supervision, support and enthusiasm during the last years.

Zonder de deelnemers van het onderzoek was dit doctoraat er nooit geweest. Ik wil

iedereen die heeft deelgenomen aan het onderzoek van harte bedanken om met zoveel

engagement, vertrouwen en openheid het therapeutisch traject te doorlopen. Jullie

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hebben me zoveel geleerd en hebben me de mogelijkheid gegeven om te groeien als

therapeut.

Ik wil ook mijn dankbaarheid uiten naar de kernstaf van mijn psychotherapie-opleiding,

Prof. Greet Vanaerschot, Willy Colin, Ilse Goossens en Wendy de Pree. Jullie hebben mij

gevormd als psychotherapeut en hebben mij bergen ervaring en kennis doorgegeven die

ik mijn hele leven lang zal meedragen. Ook mijn mede-opleidelingen ben ik zeer erkentelijk

voor hun steun, advies en aanwezigheid tijdens deze intense en mooie jaren.

Mijn externe supervisors, Jacqueline van der Linden, Gert de Kinder, Judit Havelka, Gerd

Govaerts en psychotherapeuten, Sigrid Vandepitte en Chris Beuckels, ben ik ook enorm

dankbaar voor hun ondersteuning en erkenning tijdens dit parcours, de moeilijke periode

van de woningbrand en andere persoonlijke uitdagingen. Bedankt ook aan Ludwig Cornil,

docent van het Belgisch EMDR Instituut Integrativa, en Freek Dhooge, voorzitter van EMDR

België, voor jullie opleiding en ondersteuning.

Naast dit professionele en academische deel van mijn sociale netwerk wil ik met heel veel

bewondering en liefde mijn familie en vrienden bedanken.

Liefste vriendinnen, Monica, Jasmijn, Katrien, Liesbet, Melissa, Ilka, Laura, Julie en Leen,

wat ben ik jullie dankbaar voor jullie luisterend oor, begrip en geduld. Of onze gesprekken

nu gingen over draagdoeken, borstvoeding, co-sleeping, gyprocwerken of congressen in

het buitenland, jullie waren steeds één en al oor. Jullie zorgden voor geruststelling,

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ontspanning, afleiding en vertrouwen. Bedankt om er voor me te zijn en telkens opnieuw

mee te gaan in mijn dromen en projecten.

De personen die al vanaf mijn geboorte onmisbaar zijn geweest, zijn jullie, mama en papa.

Wat ben ik jullie ongelooflijk dankbaar om zo in mij te geloven. Mama en papa, jullie hebben

me geleerd om mijn gevoel te volgen en vertrouwen te hebben. Jullie zorgden steeds voor

een veilige haven, of het nu hier in België of in Canada was. Jullie hebben gezocht naar

de plek waar we de meeste kansen zouden krijgen om ons te ontwikkelen en hebben

daar vaak zelf een stapje voor opzij gezet. Nu ik zelf moeder ben, ben ik me daar nog

bewuster van geworden. Jullie hebben me laten uitvliegen, openbloeien en groeien.

Bedankt, liefste mama en papa, om er voor me te zijn op alle mogelijke manieren. Wat

hebben jullie een prachtig gezin gesticht en een warm nest gecreëerd waar het heerlijk

vertoeven is.

Bedankt ook lieve zus en broers om steeds met zoveel positiviteit en interesse te reageren

op wat ik onderneem in mijn leven. Jullie inspireren me om voor mijn dromen te gaan, elk

op jullie eigen unieke manier. Bedankt om me zo te steunen en te helpen de voorbije jaren,

in het bijzonder bij de talloze verhuizen en de eindeloze renovatiewerken waar geen einde

aan leek te komen. Alison, mijn liefste zus. Een extra bedankje gaat uit naar jou. Ik

bewonder je enorm voor je talent om met woorden en zinsconstructies te toveren. Jouw

editing heeft me enorm geholpen. Ik bewonder je voor jouw prachtige doctoraat en wens

je nog veel succes en voldoening met je titel als doctor in de Engelse Literatuur.

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Graag wil ik ook mijn schoonouders en schoonfamilie bedanken voor hun steun, geduld

en begrip. Jullie zijn de voorbije jaren ook onmisbaar geweest voor mij, voor Piet en onze

dochters. Bedankt om er steeds te staan, ons op te vangen en te ondersteunen.

Gelukkig sta ik er niet alleen voor. Mijn man, steun en toeverlaat, wil ik bedanken om mee

te gaan voor één van mijn dromen. Dankzij jou heb ik dit kunnen verwezenlijken.

Bedankt, liefste Piet, om er samen met mij voor te gaan en om in mij te geloven. Bedankt

om ruimte te maken en me de tijd te geven te groeien op professioneel én op persoonlijk

vlak. Er is veel gebeurd en veranderd in de voorbije jaren. We hebben samen al heel wat

watertjes doorzwommen en bergen beklommen. Samen vormen we een sterk team, dat

hebben we de voorbije jaren wel bewezen.

Bedankt, liefste Piet en lieve dochters, Marie en Fien, om zoveel geduld en begrip te tonen.

Ik weet, liefste dochters, dat het voor jullie niet gemakkelijk is geweest om je mama soms

zo te zien stressen voor dit doctoraat wanneer jullie het liefst van al met me wilden spelen.

Jullie kunnen me ontroeren, vertederen, vermoeien en een spiegel voorhouden.

Ik zal het (h)eerlijk gesprekje met Marie nooit vergeten toen ik haar op een dag van het

eerste kleuterklasje kwam halen:

‘Waarom ben je met de auto?’

– ‘Ik ben in’t ziekenhuis gaan werken vandaag. Da’s ver.’

‘Ben jij dan een dokter?’

– ‘Nee, een psycholoog. Ik help ook mensen.’

‘Een beetje zoals een dokter?’

– ‘Ja, ik zorg voor mensen door ermee te praten.’

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‘Hoe zorg je dan voor mensen?’

– ‘Door te luisteren.’

‘Dat vind ik saai. Echt saai.’…’Waarom ben je een psycholoog?’

– ‘Ik heb daarvoor gekozen. Ik help graag mensen.’

‘Jij bent een mama en een psycholoog…Waarom?’

– ‘Tja.’

‘Ik vind dat raar. Vind jij dat niet raar, mama?’

– ‘Ja, soms wel.’ …

Mama zijn én psycholoog zijn én doctoraatsstudent zijn, was met momenten pittig. Soms

voelde het alsof ik op alle vlakken faalde. Maar dankzij jullie gegiechel, dansjes in de

badkamer, K3-optredens, moppen over worteltjestaart en eindeloze fantasiespellen met

prinsessen en zeemonsters, kon ik gelukkig een heleboel relativeren. Mijn

doctoraatsparcours als moeder heeft dan ook wat langer geduurd dan verwacht, maar de

eerste levensjaren van je kinderen haal je nooit meer in en ik koester zo alle momenten die

ik met jullie heb kunnen delen. Jullie maken mijn wereld waardevoller en mooier.

Liefste Piet en liefste dochters, bedankt om deel uit te maken van mijn leven en samen

een echte thuis te creëren.

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