The Short-Term MBT Project

Study Overview
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Brief Summary
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The study will evaluate the benefitial and harmful effects of short-term (20 weeks) compared to long-term (14 months) mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder.

Detailed Description
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Psychotherapy for borderline personality disorder is often lengthy and resource-intensive. Mentalization-based therapy is an example of an evidence-based treatment that currently has empirical support as an 18-months outpatient program for borderline personality disorder. However, this duration is rarely available, and the long and costly treatment combined with a highly prevalent disorder result in insufficient access to evidence-based care. The trial is an investigator-initiated, single-centre, assessor-blinded, randomized clinical superiority trial of short-term (20 weeks) compared to long-term (14 months) outpatient mentalization-based therapy for borderline personality disorder or subthreshold borderline personality disorder. Participants will be recruited from the Outpatient Clinic for Personality Disorders at Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark. Participants will be assessed at trial intake using the Mini International Neuropsychiatric Interview and the Structured Clinical Interview for DSM-5 Personality Disorders. Participants will be included if they meet a minimum of four DSM-5 criteria for borderline personality disorder. Participants will be assessed blind to treatment allocation at baseline, and at 8, 16, and 24 months after randomization. The primary outcome is severity of borderline symptomatology assessed using the Zanarini Rating Scale for Borderline Personality Disorder interview. Secondary outcomes include self-harm incidents, functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey), and global functioning (Global Assessment of Functioning scale). Psychiatric symptoms (Symptom Checklist 90) will be included as an exploratory outcome. Measures of personality functioning, attachment, group alliance, borderline symptoms and mentalization skills will be included as predictor and mediator variables.

Official Title
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Short-term Versus Long-term Mentalization-based Therapy for Outpatients With Subthreshold or Diagnosed Borderline Personality Disorder: a Randomized Clinical Trial

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Other: Short-term MBT
* Other: Long-term MBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria exclusive to the Outpatient Clinic Age >18 years Personality disorder(s) considered to be primary diagnosis/diagnoses Inclusion Criteria exclusive to the trial: A minimum of four DSM-5 criteria for borderline personality disorder Written informed consent Exclusion Criteria exclusive to the Outpatient Clinic: Possibility of a learning disability (IQ<75) A diagnosis of schizotypal personality disorder or antisocial personality disorder Presence of a comorbid psychiatric disorder that requires specialist treatment elsewhere Current (past 2 months) substance dependance including alcohol Concurrent psychotherapeutic treatment outside the clinic Exclusion Criteria exclusive to the trial: - Lack of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short-term MBT<br>The experimental group is short-term mentalization-based therapy. The treatment program includes 20 weeks of mentalization-based group therapy with conjoined individual therapy every second week. The program also includes psychoeducation and individual caseformulations. | Other: Short-term MBT<br>* Short-term mentalization-based therapy<br>|
| Active Comparator: Long-term MBT<br>The control group is long-term mentalization-based therapy. The treatment program includes 14 months of weekly mentalization-based group therapy with combined individual therapy every second week. The program also includes psychoeducation and individual caseformulations. | Other: Long-term MBT<br>* Long-term mentalization-based therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview | ZAN-BPD is an investigator-administered interview assessing change in severity of borderline personality disorder over time. Each of the nine DSM-5 criteria for borderline personality disorder are rated on a scale from 0-4, where 4 is the most severe, yielding a total score from 0-36. | Assessed at baseline, and at 8, 16 and 24 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional impairmment assessed with the Work and Social Adjustment Scale (WSAS) | WSAS is a 5-item questionnaire assessing change in functional impairment. Each item is rated on a scale from 0-8, where 0 is no impairment and 8 is severe impairment, yielding a total score between 0-40. | Assessed at baseline, and at 8, 16 and 24 months post-randomization | 
| Change in quality of life assessed with the Short-Form Health Survey 36 (SF-36) | SF-36 is a questionnaire assessing change in self-reported quality of life over time. The instrument measures eight health dimensions: physical function (PF), role physical (RF), bodily pain (BP), social function (SF) role emotional (RE), general health (GH), vitality (VT) and mental health (MH). The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score). | Assessed at baseline, and at 8, 16 and 24 months post-randomization | 
| Change in global functioning assessed with the Global Assessment of Functioning (GAF) | GAF is an investigator-administered rating of change in global functioning over time. Global funtioning is rated on a scale from 0-100 for both symptomatic and functional impairment, yielding two total scores from 0-100, where 100 is no impaitment and 0 is severe impairment. | Assessed at baseline, and at 8, 16 and 24 months post-randomization | 
| Change in amount of self-harm incidents | Proportion of participants with severe self-harm defined as deliberate acts of self-harm resulting in visible tissue damage - data will be collected as both dichotomous data and count data. | Assessed at baseline, and at 8, 16 and 24 months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychotherapy research, mentalization-based therapy, borderline personality disorder, randomized clinical trial, treatment intensity