931164ANP ANZJP ArticlesWalton et al.

Research

Australian & New Zealand Journal of Psychiatry 2020, Vol. 54(10) 1020–1034­ A randomised trial of dialectical https://doi.org/10.1177/0004867420931164DOI: 10.1177/0004867420931164 © The Royal Australian and and the New Zealand College of Psychiatrists 2020 Article reuse guidelines: conversational model for the treatment sagepub.com/journals-permissions of borderline personality disorder with journals.sagepub.com/home/anp recent suicidal and/or non-suicidal self-injury: An effectiveness study in an Australian public mental health service

Carla J Walton1,2,3 , Nick Bendit1,2,3, Amanda L Baker3, Gregory L Carter2,3,4 and Terry J Lewin2,3

Abstract Objectives: Borderline personality disorder is a complex mental disorder that is associated with a high degree of suffer- ing for the individual. Dialectical behaviour therapy has been studied in the largest number of controlled trials for treat- ment of individuals with borderline personality disorder. The conversational model is a psychodynamic treatment also developed specifically for treatment of borderline personality disorder. We report on the outcomes of a randomised trial comparing dialectical behaviour therapy and conversational model for treatment of borderline personality disorder in a routine clinical setting. Method: Participants had a diagnosis of borderline personality disorder and a minimum of three suicidal and/or non-sui- cidal self-injurious episodes in the previous 12 months. Consenting individuals were randomised to either dialectical behav- iour therapy or conversational model and contracted for 14 months of treatment (n = 162 commenced therapy). Dialectical behaviour therapy involved participants attending weekly individual therapy, weekly group skills training and having access to after-hours phone coaching. Conversational model involved twice weekly individual therapy. Assessments occurred at baseline, mid-treatment (7 months) and post-treatment (14 months). Assessments were conducted by a research assistant blind to treatment condition. Primary outcomes were change in suicidal and non-suicidal self-injurious episodes and severity of depression. We hypothesised that dialectical behaviour therapy would be more effective in reducing suicidal and non- suicidal self-injurious behaviour and that conversational model would be more effective in reducing depression. Results: Both treatments showed significant improvement over time across the 14 months duration of therapy in suicidal and non-suicidal self-injury and depression scores. There were no significant differences between treatment models in reduction of suicidal and non-suicidal self-injury. However, dialectical behaviour therapy was associated with significantly greater reductions in depression scores compared to conversational model. Conclusion: This research adds to the accumulating body of knowledge of psychotherapeutic treatment of borderline personality disorder and supports the use of both dialectical behaviour therapy and conversational model as effective treatments in routine clinical settings, with some additional benefits for dialectical behaviour therapy for persons with co-morbid depression.

1Centre for , Hunter New England Mental Health Service, Corresponding author: Newcastle, NSW, Australia Carla J Walton, Centre for Psychotherapy, Hunter New England Mental 2Priority Research Centre for Brain and Mental Health Research, The Health Service, PO Box 833, Newcastle, NSW 2300, Australia. University of Newcastle, Callaghan, NSW, Australia Email: [email protected] 3School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia 4Consultation Liaison Psychiatry, Calvary Mater Hospital, Waratah, NSW, Australia

Australian & New Zealand Journal of Psychiatry, 54(10) Walton et al. 1021

Keywords Borderline personality disorder, randomised controlled trial, psychotherapy, dialectical behaviour therapy, conversational model, effectiveness, depression, suicidal behaviour, non-suicidal self-injurious behaviour

Borderline personality disorder (BPD) is associated with a There are two studies, adequately powered by large high degree of suffering, high rates of suicide attempts (Lieb sample sizes and where DBT was delivered with fidelity, et al., 2004) and a lifetime suicide mortality rate of approxi- which have compared DBT with another ‘active’ treatment. mately 10% (Black et al., 2004). Beyond high levels of Linehan et al. (2006a) compared DBT with ‘treatment by symptomatic impairment, large-scale studies have shown experts’ that included clinicians in the community with pervasive social and functional impairment (Gunderson expertise in treating BPD using non-DBT treatments. DBT et al., 2011). Depression commonly co-occurs with BPD was found to be superior on outcomes of suicide attempts, (Beatson and Rao, 2013). Within mental health settings, treatment retention and service utilisation. McMain et al. approximately 10% of all psychiatric outpatients and (2009, 2012) compared DBT with general psychiatric man- between 15% and 25% of psychiatric inpatients meet crite- agement (GPM), a psychodynamic therapy with a medica- ria for BPD (Leichsenring et al., 2011). During the past tion algorithm and found both treatments demonstrated 30 years, there has been considerable progress in treatments significant reductions in suicidal behaviour and NSSI developed and evaluated for BPD. Psychiatric medication between pre-treatment and post-treatment, as well as on a is not a recommended first-line treatment as it does not alter range of other clinically relevant measures. the course of the disorder and psychotherapy is the indi- There is no direct evidence from comparisons of active cated treatment for BPD (National Collaborating Centre for models developed specifically for the treatment of BPD Mental Health (NCCMH), 2009; National Health and that any one form of psychotherapy is superior to any other Medical Research Council (NHMRC), 2012). model. In the most recent Cochrane review of BPD (Stoffers A number of cognitive behavioural therapies have been et al., 2012), the authors outlined several limitations of developed or adapted specifically for the treatment of BPD studies of outpatient psychotherapeutic treatment for BPD. with varying degrees of evidence from randomised trials Many have small sample sizes (range, n = 47–180). Apart (Stoffers et al., 2012). Dialectical behaviour therapy (DBT) from DBT, most treatments have only been evaluated in is one of these therapies and targets skill development to one or two studies (Stoffers et al., 2012) and the majority of build a ‘life worth living’ (Linehan and Wilks, 2015). DBT studies have been conducted by investigators who devel- has been the focus of more clinical trials than any other psy- oped the treatment or who have a strong allegiance to one chotherapy for BPD (Cristea et al., 2017). Across these trials, particular model (Bateman and Fonagy, 2009; Giesen-Bloo results generally show a reduction in suicidal and non-­ et al., 2006; Levy et al., 2006; Linehan and Wilks, 2015). suicidal self-injurious (NSSI) episodes and psychiatric hos- Among psychotherapy studies in which all investigators pital admissions. Beyond cognitive behavioural therapies, have allegiance to one particular model, outcomes have been there is evidence from randomised trials for numerous psy- consistently in support of that treatment model (Luborsky chodynamic therapies developed specifically for the treat- et al., 1999). Researcher allegiance is now well recognised as ment of BPD (Bateman and Fonagy, 1999, 2009; Clarkin affecting results (Leichsenring et al., 2017). Hence, replica- et al., 2007; Gunderson and Links, 2014). Conversational tions are needed, particularly by independent researchers not model (CM) was originally developed by Hobson and involved in treatment development. Furthermore, most have Meares and then further developed by Meares as a specific been conducted in university settings by highly trained ther- model to treat BPD, targeting the development of a healthy apists; consequently, it is unclear how well effects would sense of self (Meares, 2004, 2012). It focuses heavily on the generalise to real-world clinical settings (Roy-Byrne et al., therapeutic relationship as a template for other relationships 2003). and aims to help individuals increase their capacity to build a The aims of this study were (1) to evaluate DBT in a reflective awareness of inner events (Meares, 2012: 20). CM routine clinical setting and compare it against an active has been evaluated for BPD in a published study (Stevenson treatment and (2) to compare CM against another therapy and Meares, 1992), utilising a pre-post design, with a replica- for BPD with an established evidence base. CM was tion study (Korner et al., 2006), using a treatment as usual selected as the active treatment for this study based on the waiting list control, but has not yet been tested in a ran- promising evidence and because it is one of few treatments domised trial. Both CM studies showed significant reduction specifically designed for treatment of BPD that is taught in suicidal behaviour and NSSI, and hospital admissions and used in Australia (Korner and McLean, 2017). This after 1 year of therapy, with gains maintained at 5-year fol- study attempted to address some of the limitations identi- low-up (Stevenson et al., 2005). fied above.

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Method substance dependence other than nicotine (as measured by SCID-I; but eligible for entry once no longer meeting the Study design criteria for dependence) and prior treatment with DBT or This is a single-site, two-armed parallel randomised con- CM (as reported by the patient). trolled trial (RCT) designed to investigate the effectiveness of CM and DBT in a public sector mental health service in Procedure Australia. The sample population comprised adults with a Upon referral, patients were allocated an appointment for primary diagnosis of BPD and recent suicide attempts and/ an initial assessment with an allied health clinician or nurse or NSSI episodes. The main aim of this study was to com- therapist (all with a minimum of 5 years’ mental health pare CM with DBT for two primary outcomes at post-­ experience) to determine whether they met eligibility crite- treatment (14 months): (1) change in the number of ria for the service. If they met the criteria, they attended a combined endpoint episodes of suicidal behaviour and diagnostic interview with a consultant psychiatrist. NSSI and (2) change in depression severity. We expected All patients meeting the inclusion criteria were invited that (1) both treatments would lead to significant change by a research assistant to participate in the study. Patients after 14 months, (2) DBT would be more effective in reduc- were provided with a full explanation of the procedures and ing the number of episodes of suicidal and NSSI after study conditions. Written informed consent was obtained 14 months and (3) CM would be more effective in reducing from all participants. Participants received AUD$20 per depression severity after 14 months. The study was assessment to cover transport and related costs. Consenting approved by the Hunter New England Human Research participants were randomly allocated to either DBT or CM. Ethics Committee (Reference Number: 06/12/13/5.11) and Figure 1 illustrates the flow of participants in the RCT. registered with the Australian New Zealand Clinical Trials A stratified randomisation procedure was used to max- Registry (ACTRN 12612001187831). imise the likelihood of comparable distributions across groups for gender and antidepressant use. A computerised Participants formula with blocked randomisation (blocks of 4) was used by an independent research manager of the health service. This study was conducted at the Centre for Psychotherapy, A sealed, opaque envelope containing randomisation status a specialist outpatient service for BPD and/or Eating was given to participants at the end of their assessment. Disorders of the Hunter New England Mental Health Participants were instructed not to tell the research assistant Service, located in Newcastle, New South Wales, Australia. the treatment to which they had been randomised. After Referrals were accepted from community mental health randomisation, the waiting list manager in the service allo- teams, general practitioners or private therapists. There cated participants to a therapist. Participants commenced were no treatment costs for patients. Recruitment started in therapy within 2 weeks of randomisation. January 2007, and the final sample size of 162 was reached As is consistent with psychotherapy trials for BPD, in April 2013. The final post-treatment data (14 months) medication was not standardised; its type and amount were collection occurred in June 2014. decided on an individual basis by participants’ medication The inclusion criteria for this study (and the service) providers (general practitioners or psychiatrists). were as follows: (1) BPD according to Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) criteria (American Psychiatric Association (APA), 1994) – Assessments with the diagnosis of BPD made by a consultant psychia- Data were collected at three time points: baseline (T0), mid- trist using the Structured Clinical Interview for the treatment mark of 7 months (T1) and post-treatment at Diagnostic and Statistical Manual of Mental Disorders, 4th 14 months (T2). Follow-up data are being collected at three edition (SCID-II; First et al., 1995); (2) three episodes of additional time points: 1 year (T3), 2 years (T4) and 5 years suicide attempts and/or NSSI in the past 12 months, where (T5) follow-up. Only time points T0, T1 and T2 will be NSSI behaviour is defined in accordance with the Suicide reported in this article, with T2 the primary endpoint. Attempt and Self-injury Count (SASI-Count; Linehan and Experienced research assistants with a minimum bach- Comtois, 1996) as acute, intentional self-injurious behav- elor’s degree in psychology conducted all research assess- iour such as cutting, overdosing, burning and deliberate ments, blind to treatment allocation status. To maintain self-poisoning without the intention of dying; and (3) aged blindness, the research assistant was scheduled to work at between 18 and 65 years. The exclusion criteria for this different times to when the skills training groups were run. study were as follows: disabling organic conditions, current acute psychotic illness, antisocial behaviour that posed a Primary outcome measures significant threat to staff and fellow patients, developmen- tal disability, living more than 1 hour’s drive from the treat- There were two primary outcomes: change from baseline to ment centre, inability to speak or read English, current post-treatment in (1) number of episodes of suicidal and

Australian & New Zealand Journal of Psychiatry, 54(10) Walton et al. 1023

Figure 1. Flowchart of participants (CONSORT diagram).

DBT: dialectical behaviour therapy; CM: conversational model; T0: baseline; T1: 7 months of therapy (mid-treatment); T2: 14 months of therapy (post-treatment).

NSSI and (2) self-reported depression severity scores. and Comtois, 1996; Linehan et al., 2011). The SASI- While the primary outcome comparison was baseline to Count is a brief clinician-administered measure cat- post-treatment, two other planned comparisons were also egorised into suicide attempts and non-suicidal acts assessed: change from baseline to mid-treatment and from within a specified period. This study utilised an mid-treatment to post-treatment. adapted time frame of behaviour occurring within the The specific measures used to evaluate each outcome past 7 months. The SASI-Count is a briefer version of are summarised below with the outcome domain identified the Suicide Attempt Self Injury Interview (SASII; first, followed by the measure used: Linehan et al., 2006b) which assesses self-injury in more detail. The SASII has demonstrated good reli- (a) Combined outcome of any episode of suicidal and ability and validity. The SASI-Count was chosen non-suicidal self-injury: the SASI-Count (Linehan over the SASII to reduce assessment burden.

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(b) Depression severity: Beck Depression Inventory II Participants indicate responses on a 4-point Likert (BDI-II; Beck et al., 1996). We chose the BDI-II scale ranging from 1 (Strongly Agree) to 4 (Strongly because in our clinical experience dysphoria and Disagree). self-reported depression are often the symptoms that (e) Mindfulness: Kentucky Inventory of Mindfulness clients report as most distressing, and because sev- Skills (KIMS; Baer et al., 2004). The KIMS is a eral previous seminal studies of BPD have incorpo- 39-item self-report inventory used for the assess- rated the BDI-II (Bateman & Fonagy, 1999; Linehan ment of mindfulness skills. Mindfulness is generally et al., 1991; 2006a; McMain et al., 2009). The BDI-II defined to include one’s attention in a non- is a self-report instrument designed to assess and judgmental way or accepting the experience occur- detect the severity of current (past 2 weeks) depres- ring in the present moment (Baer et al., 2004). sive symptoms and contains 21 descriptive state- Participants indicate responses on a 5-point Likert ments frequently reported by individuals diagnosed scale ranging from 1 (Never or very rarely true) to 5 with depression. Each of the items contains a 4-point (Very often or always true). The instrument has good severity-rating scale. It is a widely used, reliable internal consistency and adequate to good test–retest measure of depressive symptoms. It has high inter- reliability. It demonstrates good content and concur- nal consistency and correlates well with other self- rent validity, correlating positively with other related report measures of depression and with clinician measures. ratings of depression (r = 0.60–0.90; see Beck et al., (f) Emotion regulation: The Difficulties in Emotion 1987, for a review). Regulation Scale (DERS; Gratz and Roemer, 2004). The DERS is a 36-item self-report questionnaire Secondary outcome measures designed to assess multiple aspects of emotion dys- regulation during times of distress. Participants indi- (a) BPD Severity: Borderline Personality Disorder cate responses on a 5-point Likert scale ranging Severity Index (BPDSI-IV; Arntz et al., 2003). The from 1 (Almost never) to 5 (Almost always). The BPDSI is a semi-structured interview based on DERS has been found to have high internal consist- DSM-IV criteria, assessing the frequency and sever- ency (Cronbach’s α = 0.93), good re-test reliability, ity of various aspects of BPD. It has 70 items and the and adequate construct and predictive validity. reference period is 3 months. It has high inter-rater reliability and high internal consistency (intra-class Treatment correlation = 0.97, Cronbach’s α = 0.93), and high concurrent and discriminant validity. Patients were required to commit to 14 months of twice (b) Interpersonal problems: Inventory of Interpersonal weekly psychotherapy in either programme: twice weekly Problems (IIP; Horowitz et al., 1988). The IIP is a individual therapy sessions in the CM condition, and a once self-administered questionnaire for assessment of weekly individual therapy session and once weekly skills subjectively experienced interpersonal difficulties. training group session in the DBT condition. The IIP and its derivatives provide an overall quanti- tative index of interpersonal problems and scores on DBT. DBT is a manualised treatment (Linehan, 1993a, eight subscales. Each subscale consists of eight 1993c) for BPD that combines treatment strategies from items answered on 5-point scales from 0 (Not at all) behavioural, cognitive and supportive . In to 4 (Extremely). It has high internal consistency this study, it included weekly individual pre-treatment ses- (Cronbach’s α = 0.96) and good convergent validity sions for approximately 4 weeks. Pre-treatment sessions (Horowitz et al., 1988). included orientation to the treatment model, exploring (c) Dissociation: Dissociative Experiences Scale (DES; goals and eliciting a commitment to therapy. Pre-treatment Bernstein and Putman, 1986). The DES is a 28-item sessions were followed by concurrent weekly individual self-report measure designed to quantify dissocia- and skills training group sessions for 12 months. Individual tive experiences. The DES has strong internal relia- therapy sessions took approximately 1 hour per week and bility (mean Cronbach’s α = .93), very good applied directive, problem-oriented techniques (including convergent validity and good predictive validity behavioural skill training, and with Dissociative Identity Disorder and PTSD. cognitive modification) alongside supportive techniques. (d) Sense of self: Sense of Self Inventory (SSI; Basten, The skills group met weekly for 2.5 hours and followed a 2008). The SSI is a 23-item self-report measure psycho-educational format. It included teaching and appli- designed to identify several core components that cation of skills, and targeted practice. reflect the subjective and continuous experience of Participants had access to telephone coaching with their being an individual, authentic person who is in con- individual therapist during working hours. Outside of this, trol of their own mental and physical activities. participants had access to a telephone service staffed by a

Australian & New Zealand Journal of Psychiatry, 54(10) Walton et al. 1025 roster of DBT therapists, available 7 days per week from training. Many had completed additional 2-day training 8:30 a.m. to 10:00 p.m. DBT therapists attended a weekly sessions with the treatment developer’s training company, consultation team meeting designed to provide support and Behavioral Tech. The majority completed 10-day DBT assist therapists to be adherent to treatment. intensive training with Behavioral Tech. The 14-month schedule allowed for the pre-treatment Therapists providing treatment in the CM arm of the phase in DBT to occur before participants commenced 48 trial attended an introductory programme; this involved a sessions of skills training that occurred concurrently with series of a minimum of 6 × 2-hour seminars. For psychiat- individual therapy. ric trainees and psychiatrists, due to scheduling difficulties, the initial training involved meeting one on one with a staff CM. Participants in the CM treatment arm attended twice specialist psychiatrist (N.B.) with extensive experience in weekly individual therapy for 14 months. The treatment the model. The majority of therapists in the CM arm of the model was developed by Meares (2004) and is outlined in a trial had either completed or were completing a 3-year part- published treatment manual (Meares, 2012). The sessions time diploma in CM with the treatment developer’s training were approximately 1 hour and were nondirective with the organisation, Australian and New Zealand Association of focus on understanding the patient’s emotional experience Psychotherapy. and actively describing that back to the patient. The therapist actively looks for subtle signs of emotionally misunderstand- Treatment fidelity ing the patient, leading to mutual self-reflection and repair of the moment of disconnection in the therapeutic relationship. Fidelity was monitored through supervision. Therapists High value was placed on the patient’s real experience (as delivering DBT attended a weekly consultation team meet- against socially acceptable experience) and the development ing. Therapists who had only recently learned DBT also of an authentic personal narrative. The patient was encour- received individual supervision initially. All CM therapists aged to find links between the maladaptive relationship pat- were involved in weekly supervision with an experienced terns they had developed in their current social world and the supervisor either individually or in pairs. relationship pattern they had with the therapist. Modality-specific adherence scales were used to evalu- Fourteen months of therapy was selected as the treat- ate treatment fidelity and will be reported in the ‘Results’ ment length to match that being received in the DBT condi- section. DBT sessions were rated by a coder trained in the tion. Previous research on CM has involved treatment of 1 use of the Dialectical Behavior Therapy Global Rating or 2 years duration. There was no explicit pre-treatment Scale (Linehan, 1993b). An overall score of 4 or higher phase in CM; however, it involved an extended assessment indicates that the session was conducted adherently. that occurred at the beginning of the 14 months. Reliability checks were conducted between the coder and a member of Linehan’s team. In the absence of a suitable Therapists adherence scale for CM at the start of the study, one was developed for use for this study. CM sessions were rated by Treatment was delivered by 32 therapists, all with a mini- a coder trained in the use of the Newcastle Adherence Scale mum of 2 years of clinical experience. Therapists were for CM (NASCOM; Goldman, 2012). The NASCOM is a employed in the government health service and not hired 25-item scale in which the items have been demonstrated to specifically for this trial. The majority were employees of the have good inter-rater reliability and good discriminant Centre for Psychotherapy; some therapists were employed in validity, in that it could distinguish between adherent CM community or hospital mental health settings and served as and DBT sessions. Reliability checks were conducted visiting therapists. Disciplines included psychologists, psy- between the coder and the scale developer. chiatrists or psychiatric trainees, social workers, mental Adherence raters were blind to treatment allocation. A health nurses and occupational therapists. Some therapists randomly selected 5% sample of all sessions was rated for provided treatment in both models (n = 12), some provided adherence. Therapists were not provided with the results of treatment in DBT only (n = 7), and some in CM only (n = 13). the adherence coding until all participants had finished The number of participants treated by the 32 therapists therapy, as it is unrealistic that such feedback would be ranged from 1 to 16 and there was a different pattern among accessible in a real-world setting. those who provided only one therapy (n = 20) with a mean number of patients of 2.42 (median = 2) compared with those Statistical analysis who provided both (n = 12, mean = 9.67, median = 9.5). Sample size. The planned number of participants in the Supervision study was 162, based on the assumption that two-thirds would be retained at post-treatment (i.e. 54 participants per Therapists providing treatment in the DBT arm of the trial intervention condition). Family-wise Bonferroni-corrected were required to complete a minimum of 4 days of DBT statistical tests were employed throughout – namely alpha

Australian & New Zealand Journal of Psychiatry, 54(10) 1026 ANZJP Articles divided by 2 for the two primary outcome measures (i.e. Results 0.025), and alpha divided by 6 for the secondary outcome measures (i.e. 0.0083). It was expected that a retained Recruitment sample of 108 participants at post-treatment would pro- Participant flow across the trial is presented in Figure 1. In vide sufficient statistical power (80%) to detect modest total, 269 patients were referred to the service during the population associations (e.g. simple or partial correla- recruitment period, of whom 45 did not meet inclusion cri- tions, standardised regression weights for group compari- teria for the study and 58 declined to participate. A total of sons or interactions, etc.) of 0.30 or higher for the primary 166 people consented to randomisation and completed outcome measures, using two-tailed statistical tests in the research assessments. Four of these did not attend the first sample, or 0.34 or higher in the case of the secondary therapy appointment, leaving 162 participants included in outcome measures; which equates to the detection of the study (see Figure 1) who gave written informed consent standardised population differences between treatment and attended at least one therapy session. conditions (i.e. Effect Sizes) of 0.59 and 0.67, respectively. Patient characteristics Analysis. All patients who were randomised and attended Selected demographic and clinical characteristics of the a minimum of one treatment session after the baseline two groups are presented in Table 1. Participants were assessment were included in the analysis. All available mainly single, White Caucasian women in their 20s, with data from the three time points were included in each varying levels of education. The two groups showed no analysis (not just complete pairs), using specific planned imbalances at baseline after randomisation with regard to comparisons to examine differences between time points sociodemographic and clinical characteristics. (and account for the repeated-measures component of the variance). For consistency, major outcome analyses involving continuous measures were based on change Treatment outcomes scores from baseline (T0), expressed as either mid-treat- Intent-to-treat analyses showed a significant reduction over ment (T1) or post-treatment (T2) minus baseline phase. time in both primary outcomes of (1) any suicidal and/or Negative binomial models were utilised in the analyses NSSI (Wald’s χ2 = 41.59, p < 0.001) and (2) depression examining suicide attempts, NSSI and their aggregation, severity (Wald’s χ2 = 142.02, p < 0.001). These results are effectively treating these data as counts. All of the analy- detailed in Table 2. There were no significant differences ses included as a co-variate the baseline raw scores for between DBT and CM on suicidal and/or NSSI. Suicidal the particular measure being investigated. Generalised behaviour and NSSI were also examined separately, show- linear modelling techniques (generalised estimating ing a similar pattern of results (see Table 2 and Figures 2–4). equations, GEEs) were used to examine differences There were no deaths in either group. Compared to CM, between groups in the changes over time (with within- DBT was associated with a significant differential benefit subject variation coded using subject IDs and study time in depression severity scores from baseline to mid-­ point); an ‘independent’ working correlation matrix was treatment (Wald’s χ2 = 8.05, p = 0.005) and from baseline specified (i.e. uncorrelated repeated measurements), with to post-treatment (Wald’s χ2 = 8.00, p = 0.005); see the other patterns also examined that confirmed the stability group × time interaction effects in Table 2 and the associ- of parameter estimates. For both primary and secondary ated mean changes displayed in Figure 5. outcomes, z scores were also calculated to illustrate stan- At baseline, 78% of the overall sample fell in the ‘severe’ dardised change, expressed in relation to the grand SD of BDI-II category (score of 29–63), comprising 83% of the change. SPSS 22.0 software package for Windows was DBT condition and 74% of the CM condition. At post-treat- used for statistical analyses. ment, only 25% fell in the ‘severe’ category, comprising 18% of the DBT condition and 30% of the CM condition. Treatment of missing data Analyses of all secondary outcomes showed significant improvement over time (see Table 3). Based on the absence As shown in Figure 1, 28 participants were lost to follow- of group × time interactions, there were no significant dif- up evaluation at post-treatment in the DBT condition, ferences between DBT and CM with respect to changes in compared with 20 participants in the CM condition. To BPD severity, interpersonal problems, dissociation or sense take into account missing data and maximise usage of all of self. DBT showed a significant differential benefit available data, major analyses comprised a series of gen- between baseline to mid-treatment (Wald’s χ2 = 11.76, eralised linear models (and, where appropriate, GEE anal- p = 0.001) and baseline to post-treatment (Wald’s χ2 = 8.16, yses), together with some supplementary sensitivity p = 0.004) in improving mindfulness skills and from base- analyses (e.g. restricted to participants completing post- line to post-treatment in changes in emotion regulation treatment assessments). skills (Wald’s χ2 = 7.04, p = 0.008).

Australian & New Zealand Journal of Psychiatry, 54(10) Walton et al. 1027

Table 1. Baseline sociodemographic and clinical characteristics of participants.

Statistical comparisona

Overall (n = 162) DBT (n = 81) CM (n = 81) χ2 or t-test p

Sociodemographic variables

Age, years: mean (SD) 26.6 (7.8) 25.8 (7.4) 27.3 (8.1) t = −1.260 0.210

Female, n (%)b 125 (77%) 62 (77%) 63 (78%)

Highest level of education, n (%) χ2 = 4.444 0.349

No high school certificate 49 (31%) 30 (37%) 19 (25%)

Completed high school 27 (17%) 12 (15%) 15 (20%)

Post-secondary, e.g., trade 33 (21%) 13 (16%) 20 (26%)

Some university 31 (20%) 16 (20%) 15 (20%)

University degree 18 (11%) 10 (12%) 8 (10%)

Employed, n (%) 59 (37%) 30 (38%) 29 (37%) χ2 = 0.002 0.967

Ethnic origin, n (%) χ2 = 0.084 0.959

White Caucasian 139 (86%) 69 (85%) 70 (86%)

Aboriginal 10 (6%) 5 (6%) 5 (6%)

Other 13 (8%) 7 (9%) 6 (7%)

English as first language, n (%) 157 (97%) 79 (98%) 78 (96%) χ2 = 0.206 0.650

Marital status, n (%) χ2 = 3.575 0.311

Single 95 (59%) 44 (54%) 51 (63%)

Married/De-facto 54 (33%) 32 (40%) 22 (27%)

Divorced 13 (8%) 5 (6%) 8 (10%)

Clinical variables

Lifetime Axis I Psychiatric Diagnoses

Any anxiety disorder, n (%) 111 (69%) 54 (67%) 57 (70%) χ2 = 0.258 0.612

Any substance use disorder, n (%) 95 (59%) 50 (62%) 45 (56%) χ2 = 0.636 0.425

Current Axis I Psychiatric Diagnoses

Major depressive disorder, n (%) 84 (52%) 43 (53%) 41 (51%) χ2 = 0.099 0.753

Any anxiety disorder, n (%) 89 (55%) 42 (52%) 47 (58%) χ2 = 0.623 0.430

Any substance use disorder, n (%) 45 (28%) 24 (30%) 21 (26%) χ2 = 0.277 0.599

Axis II Diagnoses (excluding BPD), 1.5 (1.4) 1.5 (1.5) 1.5 (1.3) t = 0.433 0.658 mean (SD)

Psychotropic medication at baseline, n (%) 117 (73%) 56 (70%) 61 (76%) χ2 = 0.795 0.373

Antidepressant use at baselineb 99 (62%) 49 (61%) 50 (63%)

DBT: dialectical behaviour therapy; CM: conversational model; BPD: borderline personality disorder. aPearson’s chi-square or t-test was used depending on whether the variable was categorical or continuous. bBoth gender and antidepressant use at baseline were stratified.

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Table 2. Generalised linear model results of primary outcomes of suicide attempts and NSSI and depression severity.

Treatment

Variable DBT (n = 81) CM (n = 81) Time effectsa Group × time effectsb Change Change Wald’s Mean (SD) Z score Mean (SD) Z score χ2 pc Wald’s χ2 pc

Primary outcome: suicide attempts and NSSI (n = 162)d

T0 Baseline 66.77 (109.30) 79.53 (114.38) T0 v T1: <0.001 G × T v 0.879 21.16 0 T1: 0.02

T1 7 months 31.72 (69.68) [0.317] 39.72 (75.68) [0.410] T1 v T2: 0.001 G × T v 0.783 11.30 1 T2: 0.08

T2 14 months 10.10 (35.95) [0.496] 15.00 (30.09) [0.580] T0 v T2: <0.001 G × T v 0.714 41.59 0 T2: 0.13 Suicide attempts (n = 95)d

T0 Baseline 19.96 (51.4) 9.71 (26.69) T0 v T1: 0.002 G × T v 0.529 9.20 0 T1: 0.40

T1 7 months 2.79 (8.49) [0.391] 2.21 (4.12) [0.179] T1 v T2: 0.420 G × T v 0.355 0.65 1 T2: 0.85

T2 14 months 1.22 (2.75) [0.449] 2.42 (13.94) [0.175] T0 v T2: 0.002 G × T v 0.223 9.94 0 T2: 1.48 Non-suicidal self-injury (n = 147)d

T0 Baseline 63.00 (92.17) 77.51 (113.53) T0 v T1: <0.001 G × T v 0.958 19.70 0 T1: 0.00

T1 7 months 32.73 (68.92) [0.287] 39.59 (77.74) [0.438] T1 v T2: 0.001 G × T v 0.815 10.97 1 T2: 0.06

T2 14 months 10.04 (37.08) [0.492] 14.19 (27.90) [0.630] T0 v T2: <0.001 G × T v 0.828 40.59 0 T2: 0.05 Primary outcome: depression severity (n = 162)

T0 Baseline 38.63 (10.31) 35.64 (10.68) T0 v T1: <0.001 G × T v 0.005 107.92 0 T1: 8.05

T1 7 months 23.08 (12.36) [1.019] 26.61 (13.73) [0.582] T1 v T2: <0.001 G × T v 0.416 24.27 1 T2: 0.66

T2 14 months 15.94 (14.52) [1.479] 22.13 (17.78) [0.912] T0 v T2: <0.001 G × T v 0.005 142.02 0 T2: 8.00

DBT: dialectical behaviour therapy; CM: conversational model; SD: standard deviation; NSSI: non-suicidal self-injury; GEE: generalised estimating equations.

T0 = Baseline; T1 7 months (mid-treatment); T2 14 months (post-treatment). Significance levels for primary outcomes are 0.025 (Bonferroni correction for two primary outcomes), with significant effects in bold. a Time main effects: T0 v T1: baseline-mid-treatment; T1 v T2: mid-post-treatment; T0 v T2: baseline-post-treatment. b Effects for interaction by group and time: G × T0 v T1: group × time effect for baseline-mid-treatment; T1 v T2: group × time effect for mid-post- treatment; T0 v T2: group × time effect for baseline-post-treatment. c Sensitivity analyses restricted to participants who completed the T2 assessment produced the same set of significant comparisons. dFor the suicide attempts and NSSI GEE analyses, negative binomial models were used, treating the data as counts. All participants were included in the aggregated primary outcome analysis, while the sub-analyses of suicide attempts and NSSI only included participants with those behaviours at baseline.

Australian & New Zealand Journal of Psychiatry, 54(10) Walton et al. 1029

Figure 2. Mean number of suicide attempts and NSSI Figure 4. Mean number of episodes of NSSI across T0-T2 across T0-T2 time points by condition. time points by condition.

Figure 3. Mean number of suicide attempts across T0-T2 time points by condition.

Figure 5. Depression severity scores (BDI-II) across T0-T2 time points by condition.

Comparison of treatment completers and those who dropped out treatment was comparable for participants in DBT (n = 81, mean = 10.38, SD = 4.49 months) and CM therapy (n = 81, Of those assigned to DBT, 45 (56%) completed the full mean = 10.59, SD = 4.60 months). Likewise, among partici- 14 months of treatment, compared to 48 (59%) of those pants who dropped out, time spent in treatment was compa- assigned to CM. Those who did not continue with treatment rable for DBT (n = 36, mean = 5.86, SD = 2.85 months) and were encouraged to attend for assessments; however, only CM therapy (n = 33, mean = 5.64, SD = 3.18 months; F(1, 67) = 36% completed their post assessment. In contrast, 98% of 0.96, p = 0.758). those who completed treatment completed their post assessment. Adherence We conducted two-way analyses of variance (treatment group × treatment drop-out status) examining baseline dif- The average adherence score on the DBT Adherence Rating ferences and found only one significant interaction effect, Scale was 4.1 (Linehan, 1993b) and 77% of sessions had a

F(1, 158) = 6.50, p = 0.012, for baseline BPD severity. Within score of 4.0 or above. The average adherence score on the the DBT group, those who dropped out had higher scores Newcastle Adherence Scale for Conversational Model was on the BPDSI (mean = 43.28, SD = 10.90) than those who 3.9, and 99% of sessions had a score of 2 or above (the cut- completed treatment (mean = 37.60, SD = 11.37). The off for adherence). For the 12 therapists providing both opposite pattern occurred in the CM group, with those DBT and CM, 30 sessions of DBT and 30 sessions of CM who dropped out having lower scores (mean = 34.27, were assessed on the scale for the alternative therapy, for SD = 12.96) compared with those who completed treat- example, DBT sessions were rated on the CM adherence ment (mean = 38.53, SD = 13.43). Overall, time spent in scale and vice versa. All 60 sessions were identified as

Australian & New Zealand Journal of Psychiatry, 54(10) 1030 ANZJP Articles 0.445 0.011 0.819 0.130 0.800 0.834 0.946 0.296 0.491 p 0.180 0.791 0.063 0.136 0.004 0.008

0.001 b : 8.16 : 7.04 : 11.76 2 2 1 : 0.58 : 6.49 : 0.05 : 2.30 : 0.06 : 0.04 : 0.01 : 1.09 : 0.47 : 1.80 : 0.07 : 3.46 : 2.22 2 1 2 2 1 2 2 1 2 2 2 1 2 2 v T v T v T × time Effects v T v T v T v T v T v T v T v T v T v T v T v T v T 0 0 0 0 0 1 0 0 1 0 0 1 0 1 0 1 T T T × × × × T × T × T × T × T × T × T × T × T × T × T × T × T G G G G G G G G G G G G G G G Group Wald’s χ Wald’s G time effect for baseline-post-treatment. c × < 0.001 < 0.001 < 0.001 < 0.001 0.007 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 p : group 2 v T 0 a 2 : 198.55 : 14.87 : 26.52 :49.21 : 7.28 : 35.00 : 50.88 : 33.83 : 49.96 : 100.52 : 30.46 : 16.64 : 61.71 : 50.26 : 39.17 : 111.82 2 1 2 2 1 2 2 1 2 2 1 2 2 1 2 2 0.032); other significant comparisons were unaffected. = v T v T v T v T v T v T v T v T v T v T v T v T v T v T v T v T 0 0 1 0 0 1 0 0 1 0 0 1 0 0 1 0 Wald’s χ Wald’s T T T T T T T T T T T Time effects T T T T T time effect for mid-post-treatment; T Z Score [1.231] [0.093] [0.582] [0.213] [0.671] [0.420] [1.004] [0.178] [0.525] [0.464] [0.900] × : group 2 v T 1 (SD) (11.10) (30.99) (39.89) (18.99) (19.31) (14.28) (18.18) (20.35) (23.93) (25.21) (33.90) (12.50) (31.81) (18.02) (10.45) (17.93) (21.10) : baseline-post-treatment. 2 Mean 19.49 116.62 99.08 28.55 22.35 64.08 55.33 104.08 111.96 118.32 105.16 36.80 120.38 32.31 70.41 99.38 133.53 CM ( n = 81) v T 0 assessment, this comparison fell below the threshold for significance ( p Z score [1.372] [0.455] [0.903] [0.257] [0.684] [0.604] [1.134] [0.688] [1.083] [0.795] [1.502] 2 time effect for baseline-mid-treatment; T × : mid-post-treatment; T 2 v T : group 1 1 (SD) (11.45) (9.83) (29.25) (36.12) (44.57) (18.14) (15.21) (12.52) (10.77) (11.82) (12.86) (16.77) (23.43) (24.81) (21.57) (24.94) (28.0) v T months (post-treatment). Significance levels for secondary outcomes are 0.0083 (Bonferroni correction six outcome s), with significant effects in bold. 0 14 2 × T Treatment DBT ( n = 81) Mean 40.13 19.00 128.43 111.90 94.25 30.50 24.85 17.31 72.56 63.50 52.38 97.46 114.09 123.88 134.34 110.55 87.08 : baseline-mid-treatment; T 1 v T 0 months (mid-treatment); T 7 1 Generalised linear model results of secondaryGeneralised linear model results outcomes. Baseline 14 months Baseline 7 months 14 months Baseline 7 months 14 months Baseline 7 months 14 months Baseline 7 months 14 months Baseline 7 months 14 months 0 2 0 1 2 0 1 2 0 1 2 0 1 2 0 1 2 = Baseline; T Emotion regulation T Variable

T Interpersonal problems T T T Dissociation T T T Sense of self T T T BPD severity T Mindfulness T T T T T 0 Effects for interaction by group and time: G In sensitivity analyses restricted to participants who completed the T Time main effects: T Table 3. Table DBT: dialectical behaviour therapy; CM: conversational model; SD: standard deviation; BPD: borderline personality disorder. T a b c

Australian & New Zealand Journal of Psychiatry, 54(10) Walton et al. 1031 non-adherent, confirming that therapists were delivering these constructs are explicitly taught in DBT (Linehan, the treatment the patient was randomised to and not blend- 1993c) and the wording in these measures uses the same ing the two therapies. language as that taught in DBT (Baer et al., 2004; Gratz and Roemer, 2004). However, it does suggest that in DBT, two key areas explicitly targeted do change in response to Discussion treatment. This study is the first effectiveness study using a ran- The dropout rates in this study were comparable across domised design of DBT and CM for treatment of suicidal the two treatments (41% for CM and 44% for DBT). and NSSI behaviour and depression severity among per- Dropout rates in this study were higher than in the DBT sons with BPD. Consistent with our first hypothesis, we efficacy studies (16% in Linehan et al.’s, 1991, original found that, on average, people who received either DBT or study and 25% in Linehan et al., 2006a), but similar to other CM had significantly less suicidal behaviour and NSSI independent trials of DBT (43% in Clarkin et al., 2007, after 14 months of treatment. The other two hypotheses 37% in Verheul et al., 2003, and 38% in McMain et al., were not supported. It was predicted that DBT would 2009). reduce suicidal behaviour and NSSI more than CM. This There was an interesting finding that those who dropped was not the case. This was surprising, as DBT deliberately out of DBT had higher scores on BPD severity than those and explicitly targets suicidal behaviour and NSSI, whereas who completed treatment. The opposite pattern occurred CM does not. However, these results are consistent with for the CM group, such that those who dropped out had findings from CM studies that suicidal and NSSI improves lower scores on BPD severity than those who completed without direct targeting (Korner et al., 2006; Stevenson treatment. It is not clear what it is about DBT that means et al., 2005; Stevenson and Meares, 1992). This result there was higher drop-out rates for those who were more aligns with a previous RCT comparing DBT and a BPD severe or correspondingly why those who were less severe adapted psychodynamic treatment (McMain et al., 2009) would be more likely to drop out of CM. This is an impor- that found no significant differences between the two active tant area for future investigation. treatments. It was also hypothesised that CM would be associated Strengths and limitations with greater improvements in depression severity scores than DBT. Although both interventions were associated There are many strengths to the current effectiveness study. with significant reductions in depression severity scores The service had already been the setting of an RCT com- over time, DBT was associated with statistically signifi- paring 6 months of DBT with waiting list control (Carter cantly lower scores than CM across the treatment year. This et al., 2010). Therefore, the feasibility of running an RCT at was also surprising, as previous studies of DBT have shown this service had already been established. The sample size inconsistent impacts on depression severity scores (Stoffers for the current trial was sufficiently large, relative to most et al., 2012). In contrast, CM in a previous wait list control previously published RCTs in the field of BPD, providing study (Stevenson and Meares, 1992) showed substantial adequate power to examine differential changes across the changes in depression severity. Numerous factors may primary and secondary outcomes. In their recent Cochrane explain why DBT performed superior to CM in reducing review of psychological therapies for BPD, Stoffers et al. depression severity: in this study, depression was assessed (2012) suggest ‘there is an urgent need for independent based on self-report measures and these may present a dif- research endeavours’ (p. 77). The current trial goes some ferent picture than clinician-administered scores; alter- way to providing such evidence, given that no author is a nately, DBT may involve more behavioural activation treatment developer, nor have they worked clinically along- which has a large amount of evidence in support of reduc- side the treatment developers. The co-principal investiga- ing depression (Ekers et al., 2014). This result provides evi- tors (C.J.W. and N.B.) are both trained in and deliver both dence for DBT impacting on patient’s internal experience models of therapy, and each is allegiant to one of the treat- beyond purely behavioural problems. ment models, as evidenced through training they provide For a range of secondary outcomes, in the domains of (C.J.W. to DBT and N.B. to CM). This provides a counter- BPD severity, dissociation, interpersonal difficulties and balance to prevent overall researcher allegiance (Luborsky sense of self, both treatment conditions contributed to sig- et al., 1999). nificant improvements over time, with no significant dif- Several elements in the trial were designed to reduce ferential changes between the therapies. These results are potential bias. Blindness of raters during assessments of consistent with previous research when two active psycho- outcome variables, and for adherence, reduced potential therapies are compared with each other; there is usually no bias. By measuring adherence in both models, cross-­ significant difference in outcome (Asarnow and Ougrin, contamination of one by the other could be excluded. 2017). DBT was superior to CM in improving mindfulness Stoffers et al. (2012) have criticised the majority of trials of and emotion regulation scores. This is less surprising since psychological therapies for BPD on the basis of the amount

Australian & New Zealand Journal of Psychiatry, 54(10) 1032 ANZJP Articles of professional contact, in that control group participants treatment of BPD (NCCMH, 2009; NHMRC, 2012) report did not receive comparable amounts of professional atten- little evidence that medication treatment in BPD is effective, tion. In this study, participants in the CM condition attended this is not an important confounding factor. twice weekly individual therapy, while those in the DBT condition attended once weekly individual therapy and Conclusion once weekly skills training. As such, the amount of atten- tion received was comparable. Both DBT and CM were associated with significant There are a number of limitations of the study. As evi- improvements in suicide attempts and NSSI. The findings denced by the baseline SDs in Table 2 for the recent sui- add to the evidence pool that DBT can be applied in rou- cidal and NSSI measures, there was a large degree of tine clinical settings with good outcomes, outside of tightly variation in these count-based indices, reflective of real- controlled research settings. This study is the first evalua- world variation in treatment-seeking samples. We dealt tion of CM in a randomised design. On most outcomes, with this variability in two ways, by utilising negative bino- CM produced comparable results to DBT, with a similar mial GEE analyses and by restricting the associated sub- level of fidelity and treatment retention. DBT was associ- analyses to participants who exhibited those specific ated with significantly better improvements than CM for behaviours at baseline; however, other approaches to such depression severity. Hence, DBT should be considered in distributional and service-delivery challenges may be worth preference to CM for individuals with co-morbid BPD and considering. On the other hand, therapies tend to be tar- depression. geted towards reducing exhibited behaviours, rather than avoidance of potential future behaviours, particularly Acknowledgements among individuals with long-standing conditions present- The authors wish to acknowledge the involvement of the study ing to services; consequently, our sub-analyses are likely to participants, without whom this research would not be possible. have real-world relevance. We are grateful to all the therapists in the trial: Agatha Conrad, Ideally, a third arm, involving a minimal treatment Bridgette Lupton, Carla Walton, Christopher Willcox, Craig control group, would have also been included. Without Hamilton, Dyani Nevile, Harsimrat Sandhu-Singh, Jane Middleby- this, we are unable to eliminate the possibility that Clements, Jennifer Koorey, Jodie Fleming, Joy Herron, Jude changes that occurred resulted from exposure to common Robinson, Karen Calabria, Kath McPhillips, Katrina Bell, Kumudu Rhatnayaka, Leonie Funk, Leslie Pollock, Linda Bragg, Linda external factors or regression to the mean. However, it Kerr, Lisa Blackwell, Maria Walker, Marianne Ayre, Megha was deemed unethical for persons at known risk of sui- Mulchandani, Natalie McCall, Nick Bendit, Phoebe Webber, Stella cide to be denied an evidence-based psychotherapeutic Dyer, Subhra Bhattacharyya, Thomas Bellamy, Yolandie Goodyear treatment when one was available. The significant results and Zoe Walker. found in this study are greater than what would have been expected if there had been no intervention; for example, Declaration of Conflicting Interests in the DBT condition there was a standardised (z-score) The author(s) declared no potential conflicts of interest with change in depression severity from baseline to post-treat- respect to the research, authorship and/or publication of this ment of 1.48, and 0.91 in the CM condition (see Table 2), article. which clearly exceed the benefits previously reported for minimal treatment control conditions. We do not have Funding information about the reasons why people dropped out of The author(s) disclosed receipt of the following financial support treatment and those who dropped out were much less for the research, authorship and/or publication of this article: No likely to attend for their assessments than those who external research funding was obtained for this project. We remained in treatment. acknowledge the support of Hunter New England Mental Health In most clinical trials, therapists only deliver one inter- Service and thank the Centre for Brain and Mental Health vention or all therapists deliver both. In this study, some Research (University of Newcastle) for providing a small grant therapists delivered only one model, and some delivered specifically to cover the cost of adherence coding. both. This is in keeping with what would frequently occur Trial Registration in routine clinical settings but introduces some potential therapist bias. Australian New Zealand Clinical Trials Registry: ACTRN Although accessing any other psychotherapy outside of 12612001187831. the trial was prohibited, there was no control of psychiatric medications. The two treatment arms were stratified for anti- ORCID iDs depressant use at baseline. Other psychiatric medications Carla J Walton https://orcid.org/0000-0001-9498-7923 were not controlled. However, as several guidelines for Terry J Lewin https://orcid.org/0000-0002-4510-4001

Australian & New Zealand Journal of Psychiatry, 54(10) Walton et al. 1033

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