Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2016-012743 on 15 September 2016. Downloaded from Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial Karen Hansen Kallesøe,1 Andreas Schröder,1 Rikard K Wicksell,2 Per Fink,1 Eva Ørnbøl,1 Charlotte Ulrikka Rask1,3 To cite: Kallesøe KH, ABSTRACT Strengths and limitations of this study Schröder A, Wicksell RK, Introduction: Functional somatic syndromes (FSS) are et al. Comparing group-based common in adolescents, characterised by severe ▪ acceptance and commitment Large-scale study in an area with limited disability and reduced quality of life. Behavioural therapy (ACT) with enhanced knowledge. usual care for adolescents treatments such as acceptance and commitment ▪ Evaluation of psychosocial and biological predic- with functional somatic therapy (ACT) has shown promising results in children tors and moderators of outcomes. syndromes: a study protocol and adolescents with FSS, but has focused on specific ▪ Thorough assessment of all patients providing for a randomised trial. BMJ syndromes such as functional pain. The current study them with evidence-based understanding of their Open 2016;6:e012743. will compare the efficacy of group-based ACT with that illness. doi:10.1136/bmjopen-2016- of enhanced usual care (EUC) in adolescents with a ▪ Assessment and treatment are carried out in a 012743 range of FSS operationalised by the unifying construct specialised setting which might affect of multiorgan bodily distress syndrome (BDS). generalisation. ▸ Prepublication history for Methods and analysis: A total of 120 adolescents ▪ Results not automatically applicable to younger this paper is available online. aged 15–19 and diagnosed with multiorgan BDS, of at adolescents given the developmental perspective, To view these files please least 12 months duration, will be assessed and with multiple symptoms being less common in visit the journal online randomised to either: (1) EUC: a manualised children and younger adolescents. http://bmjopen.bmj.com/ (http://dx.doi.org/10.1136/ consultation with a child and adolescent psychiatrist bmjopen-2016-012743). and individualised treatment plan or (2) manualised Received 20 May 2016 ACT-based group therapy plus EUC. The ACT Revised 17 August 2016 programme consists of 9 modules (ie, 27 hours) and 1 BACKGROUND follow-up meeting (3 hours). The primary outcome is Accepted 24 August 2016 Functional somatic syndromes (FSS), includ- physical health, assessed by an Short Form Health fi Survey (SF-36) aggregate score 12 months after ing chronic fatigue syndrome, juvenile bro- randomisation. Secondary outcomes include self- myalgia, functional gastrointestinal disorders reported symptom severity, symptom interference, and idiopathic pain syndromes, are well- on September 26, 2021 by guest. Protected copyright. depression and anxiety, illness worry, perceived stress known conditions in adolescents. FSS are and global improvement; as well as objective physical diagnostic unities representing clusters of activity and bodily stress response measured by heart related functional somatic symptoms. rate variability, hair cortisol and inflammatory Prevalence rates vary considerably due to dif- biomarkers. Process measures are illness perception, ferences in case definitions, assessment – illness-related behaviour and psychological flexibility. instruments and study populations.1 3 Ethics and dissemination: The study is conducted Studies attempting to cover the whole range in accordance with Helsinki Declaration II. Approval has of different functional somatic symptoms been obtained from the Science Ethics Committee of the suggest that 5–10% of children and adoles- Central Denmark Region and the Danish Data Protection. cents in the general population are substan- The results will be sought to be published according to 45 the CONSORT statement in peer-reviewed journals. tially affected and likely to need care. For numbered affiliations see Discussion: This is one of the first larger randomised Suffering from FSS during adolescence often end of article. clinical trials evaluating the effect of a group-based has high personal and societal consequences. intervention for adolescents with a range of severe FSS. Adolescents have a higher risk of psycho- Correspondence to Trial registration number: NCT02346071; social problems such as social isolation, long- Dr Karen Hansen Kallesøe; Pre-results. term school absence and reduced quality of [email protected] life,6 and anxiety and depression are Kallesøe KH, et al. BMJ Open 2016;6:e012743. doi:10.1136/bmjopen-2016-012743 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2016-012743 on 15 September 2016. Downloaded from common comorbidities.78A substantial proportion unified group-based treatment may be advantageous for show continuity of functional symptoms into adult- adolescents with various FSS due to feasibility, accessibil- – hood9 11 and are less likely to obtain a college educa- ity of treatment and potential healthcare savings. tion.9 Furthermore, adolescents diagnosed with FSS Acceptance and commitment therapy (ACT), which have higher overall healthcare costs due to increased use derives from CBT, has shown promising results in chil- of medication and healthcare services.912The aetiology dren and adolescents with chronic functional pain.44 45 of FSS remains unknown. Recent studies suggest a Evidence suggests that acceptance of pain is related to potential correlation between physiological stress and enhanced physical and emotional functioning, whereas – FSS, with physical inactivity as a potential covariate.13 16 attempts to control pain may lead to higher pain and It is proposed that a (patho)physiological response to disability.46 47 By reducing avoidance behaviour and prolonged or severe mental and/or physical stress in symptom interference, ACT can increase functioning genetically susceptible individuals may trigger symptom and enhance quality of life, through value-driven accept- development.17 ance and exposure strategies.48 Symptom avoidance High co-occurrence of different types of FSS, espe- seems to be a general problem leading to disability and cially various pain syndromes, has been shown in chil- lower quality of life in patients with FSS.49 This provides – dren and adolescents.18 20 Children reporting multiple a rationale for a therapeutic approach focused on reduc- symptoms have an associated higher frequency of dis- tion of avoidance behaviour and acceptance of somatic tress and impairment (eg, higher kindergarten/school symptoms. absenteeism and consultations with physicians).21 The objective of the present trial is to examine the Moreover, adult patients presenting with multiple symp- efficacy of ACT-based group therapy for adolescents with toms from several organ systems have a poorer prognosis a range of FSS grouped under the unifying diagnosis of – and a higher risk of chronification.22 24 Thus, an multiorgan BDS.17 To do this, we will examine physical attempt to recognise the most severely affected patients health and a range of other outcomes including level of with the highest illness burden may encompass sampling functioning, symptom interference and emotional dis- patients with the highest symptom load (ie, multiple tress at baseline, at different time points throughout the symptoms from several organ systems). Recently, the trial, and also at 12-month follow-up. An add-on study empirically based unifying diagnostic category bodily dis- includes measurement of physiological stress response tress syndrome (BDS) was introduced.25 The diagnosis and physical activity level. describes specific symptom patterns and includes a mul- tiorgan subtype and four single organ subtypes; in adult samples, it has been shown to capture a range of FSS METHODS including fibromyalgia, irritable bowel syndrome, non- Design 26 cardiac chest pain and chronic fatigue syndrome. Single-site, non-blinded randomised controlled trial http://bmjopen.bmj.com/ Multiorgan BDS comprising multiple symptoms from at (RCT) with two conditions: (1) group-based ACT and least three specific symptom groups thus offers a diag- (2) enhanced usual care (EUC). Overall study design is nostic unity potentially including the most severely illustrated in figure 1. affected patients. Cognitive–behavioural therapy (CBT) has been shown Setting to reduce symptoms and increase functioning in adults – Patients will be enlisted from the Research Clinic for with FSS,27 30 whereas the evidence for treatment in Functional Disorders and Psychosomatics, situated in a adolescents is sparse. Family-based CBT and internet- on September 26, 2021 by guest. Protected copyright. general medicine setting at Aarhus University Hospital, delivered CBT have proven effective in young patients – Denmark. The department is a specialist, tertiary service with specific FSS.31 36 However, the development of spe- with extra resources allocated for assessment and treat- cifically tailored treatments for each FSS or symptom ment of patients with debilitating functional somatic profile seems to be an inefficient strategy due to the symptoms. Enrolment starts in January 2015 and the costly nature of establishing separate clinics in each data collection is expected to be finalised in June 2019. medical (sub)specialty, the fragmented care available Prior to enrolment, an uncontrolled pilot study was and difficulty in handling multisymptomatic