The Short-Term MBT Project
- Conditions
- Borderline Personality Disorder
- Interventions
- Other: Short-term MBTOther: Long-term MBT
- Registration Number
- NCT03677037
- Lead Sponsor
- Mental Health Services in the Capital Region, Denmark
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Short-term MBT Short-term MBT 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. Long-term MBT Long-term MBT 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.
- Primary Outcome Measures
Name Time Method Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview Assessed at baseline, and at 8, 16 and 24 months post-randomization 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.
- Secondary Outcome Measures
Name Time Method Change in global functioning assessed with the Global Assessment of Functioning (GAF) Assessed at baseline, and at 8, 16 and 24 months post-randomization 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.
Change in amount of self-harm incidents Assessed at baseline, and at 8, 16 and 24 months post-randomization 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.
Change in functional impairmment assessed with the Work and Social Adjustment Scale (WSAS) Assessed at baseline, and at 8, 16 and 24 months post-randomization 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.
Change in quality of life assessed with the Short-Form Health Survey 36 (SF-36) Assessed at baseline, and at 8, 16 and 24 months post-randomization 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).
Trial Locations
- Locations (1)
Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark
🇩🇰Gentofte, Denmark