scholarly journals Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sophie Juul ◽  
Sebastian Simonsen ◽  
Stig Poulsen ◽  
Susanne Lunn ◽  
Per Sørensen ◽  
...  

Abstract Background Psychotherapy for borderline personality disorder is often extensive and resource-intensive. Mentalisation-based therapy is a psychodynamically oriented treatment option for borderline personality disorder, which includes a case formulation, psychoeducation, and group and individual therapy. The evidence on short-term compared with long-term mentalisation-based therapy is currently unknown. Methods/design The Short-Term MBT Project (MBT-RCT) is a single-centre, parallel-group, investigator-initiated, randomised clinical superiority trial in which short-term (20 weeks) will be compared with long-term (14 months) mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Outcome assessors, data managers, the data safety and monitoring committee, statisticians, and decision-makers will be blinded to treatment allocation. Participants will be assessed before randomisation and at 8, 16, and 24 months after randomisation. The primary outcome will be the severity of borderline symptomatology assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes will be functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey 36—mental component), global functioning (Global Assessment of Functioning), and proportion of participants with severe self-harm. In this paper, we present a detailed statistical analysis plan including a comprehensive explanation of the planned statistical analyses, methods to handle missing data, and assessments of the underlying statistical assumptions. Final statistical analyses will be conducted independently by two statisticians following the present plan. Discussion We have developed this statistical analysis plan before unblinding of the trial results in line with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines, which should increase the validity of the MBT-RCT trial by mitigation of analysis bias. Trial registration ClinicalTrials.gov NCT03677037. Registered on 19 September 2018

Author(s):  
Giles Newton-Howes ◽  
Roger Mulder

The management of personality disorders remains a complex and challenging area, in which significant advances have been made to our understanding over the last two decades. As an increasing understanding of the diagnosis of personality disorder is recognized, our ability to understand what interventions could be of value continues to develop. The diagnosis of borderline personality disorder is where the most significant understanding has occurred. It is now clear that these disorders can be recognized early in development and treatment should be primarily psychological. Cognitive, dynamic, and educational approaches have been trialled and found to be effective. Further, pharmacotherapy is best considered for short-term, symptom-focused use, as opposed to long-term therapy. The evidence suggests dopamine antagonists and mood stabilizers are the drugs of choice. Identifying the needs and developing strategies to meet these provide greater benefit than focusing on risk.


2020 ◽  
Vol 54 (10) ◽  
pp. 1020-1034
Author(s):  
Carla J Walton ◽  
Nick Bendit ◽  
Amanda L Baker ◽  
Gregory L Carter ◽  
Terry J Lewin

Objectives: Borderline personality disorder is a complex mental disorder that is associated with a high degree of suffering for the individual. Dialectical behaviour therapy has been studied in the largest number of controlled trials for treatment 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-suicidal self-injurious episodes in the previous 12 months. Consenting individuals were randomised to either dialectical behaviour 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.


2020 ◽  
pp. 1-9 ◽  
Author(s):  
John R. Keefe ◽  
Thomas T. Kim ◽  
Robert J. DeRubeis ◽  
David L. Streiner ◽  
Paul S. Links ◽  
...  

Abstract Background No evidence-based therapy for borderline personality disorder (BPD) exhibits a clear superiority. However, BPD is highly heterogeneous, and different patients may specifically benefit from the interventions of a particular treatment. Methods From a randomized trial comparing a year of dialectical behavior therapy (DBT) to general psychiatric management (GPM) for BPD, long-term (2-year-post) outcome data and patient baseline variables (n = 156) were used to examine individual and combined patient-level moderators of differential treatment response. A two-step bootstrapped and partially cross-validated moderator identification process was employed for 20 baseline variables. For identified moderators, 10-fold bootstrapped cross-validated models estimated response to each therapy, and long-term outcomes were compared for patients randomized to their model-predicted optimal v. non-optimal treatment. Results Significant moderators surviving the two-step process included psychiatric symptom severity, BPD impulsivity symptoms (both GPM > DBT), dependent personality traits, childhood emotional abuse, and social adjustment (all DBT > GPM). Patients randomized to their model-predicted optimal treatment had significantly better long-term outcomes (d = 0.36, p = 0.028), especially if the model had a relatively stronger (top 60%) prediction for that patient (d = 0.61, p = 0.004). Among patients with a stronger prediction, this advantage held even when applying a conservative statistical check (d = 0.46, p = 0.043). Conclusions Patient characteristics influence the degree to which they respond to two treatments for BPD. Combining information from multiple moderators may help inform providers and patients as to which treatment is the most likely to lead to long-term symptom relief. Further research on personalized medicine in BPD is needed.


2019 ◽  
Vol 65 (1) ◽  
pp. 5-15 ◽  
Author(s):  
Jennifer Wong ◽  
Anees Bahji ◽  
Sarosh Khalid-Khan

Background: Evidence regarding the efficacy of psychotherapy in adolescents with borderline personality disorder (BPD) symptomatology has not been previously synthesized. Objective: To conduct a systematic review and meta-analysis of the randomized controlled trials (RCTs) in order to assess the efficacy of psychotherapies in adolescents with BPD symptomatology. Methods: Seven electronic databases were systematically searched using the search terms BPD, adolescent, and psychotherapy from database inception to July 2019. Titles/abstracts and full-texts were screened by one reviewer; discrepancies were resolved via consensus. We extracted data on BPD symptomatology, including BPD symptoms, suicide attempts, nonsuicidal self-injury, general psychopathology, functional recovery, and treatment retention. Data were pooled using random-effects models. Results: Of 536 papers, seven trials (643 participants) were eligible. Psychotherapy led to significant short-term improvements in BPD symptomatology posttreatment ( g = −0.89 [−1.75, −0.02]) but not in follow-up ( g = 0.06 [−0.26, 0.39]). There was no significant difference in treatment retention between the experimental and control groups overall (odds ratio [ OR] 1.02, 95% confidence interval [CI], 0.92 to 1.12, I 2 = 52%). Psychotherapy reduced the frequency of nonsuicidal self-injury ( OR = 0.34, 95% CI, 0.16 to 0.74) but not suicide attempts ( OR = 1.03, 95% CI, 0.46 to 2.30). Conclusions: There is a growing variety of psychotherapeutic interventions for adolescents with BPD symptomatology that appears feasible and effective in the short term, but efficacy is not retained in follow-up—particularly for frequency of suicide attempts.


2010 ◽  
Vol 197 (6) ◽  
pp. 456-462 ◽  
Author(s):  
Kate M. Davidson ◽  
Peter Tyrer ◽  
John Norrie ◽  
Stephen J. Palmer ◽  
Helen Tyrer

BackgroundLonger-term follow-up of patients with borderline personality disorder have found favourable clinical outcomes, with long-term reduction in symptoms and diagnosis.AimsWe examined the 6-year outcome of patients with borderline personality disorder who were randomised to 1 year of cognitive–behavioural therapy for personality disorders (CBT–PD) or treatment as usual (TAU) in the BOSCOT trial, in three centres across the UK (trial registration: ISRCTN86177428).MethodIn total, 106 participants met criteria for borderline personality disorder in the original trial. Patients were interviewed at follow-up by research assistants masked to the patient's original treatment group, CBT–PD or TAU, using the same measures as in the original randomised trial. Statistical analyses of data for the group as a whole are based on generalised linear models with repeated measures analysis of variance type models to examine group differences.ResultsFollow-up data were obtained for 82% of patients at 6 years. Over half the patients meeting criteria for borderline personality disorder at entry into the study no longer did so 6 years later. The gains of CBT–PD over TAU in reduction of suicidal behaviour seen after 1-year follow-up were maintained. Length of hospitalisation and cost of services were lower in the CBT–PD group compared with the TAU group.ConclusionsAlthough the use of CBT–PD did not demonstrate a statistically significant cost-effective advantage, the findings indicate the potential for continued long-term cost-offsets that accrue following the initial provision of 1 year of CBT–PD. However, the quality of life and affective disturbance remained poor.


2017 ◽  
Vol 22 (1) ◽  
pp. 16-27 ◽  
Author(s):  
Diarmaid Ó. Lonargáin ◽  
Suzanne Hodge ◽  
Rachael Line

Purpose Previous research indicates that mentalisation-based treatment (MBT) is an effective therapeutic programme for difficulties associated with borderline personality disorder (BPD). The purpose of this paper is to explore service user experiences of the therapy. Design/methodology/approach Seven adults (five female and two male), recruited via three NHS trusts, were interviewed. Participants were attending intensive out-patient MBT for BPD between 3 and 14 months. Data were analysed using interpretative phenomenological analysis. Findings Participants experienced the group component of MBT as challenging and unpredictable. They highlighted developing trust as key to benefitting from MBT. This was much more difficult to achieve in group sessions than in individual therapy, particularly for those attending MBT for less than five or six months. The structure of MBT generally worked well for participants but they identified individual therapy as the core component in achieving change. All participants learned to view the world more positively due to MBT. Practical implications Enhanced mentalisation capacity may help address specific challenges associated with BPD, namely, impulsivity and interpersonal difficulties. MBT therapists are confronted with the ongoing task of creating a balance between sufficient safety and adequate challenge during MBT. Potential benefits and drawbacks of differing structural arrangements of MBT programmes within the UK are considered. Originality/value Learning about service user perspectives has facilitated an enhanced understanding of experiences of change during MBT in addition to specific factors that may impact mentalisation capacity throughout the programme. These factors, in addition to implications for MBT and suggestions for future research, are discussed.


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