Borderline Personality Disorder Clinical Trial
— MBT-RCTOfficial title:
Short-term Versus Long-term Mentalization-based Therapy for Outpatients With Subthreshold or Diagnosed Borderline Personality Disorder: a Randomized Clinical Trial
Verified date | January 2024 |
Source | Mental Health Services in the Capital Region, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 166 |
Est. completion date | December 15, 2023 |
Est. primary completion date | December 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark | Gentofte |
Lead Sponsor | Collaborator |
---|---|
Mental Health Services in the Capital Region, Denmark | Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in psychiatric symptom distress assessed with the Symptom Checklist 90 (SCL-90) | SCL-90 is a questionnaire assessing change in psychiatric symptom distress over time. All 90 items are rated on a scale from 0-4. The total score is divided by number of items, yielding a total score on the Global Severity Index ranging from 0 to 4, where 4 is the most severe. | Assessed at baseline, and at 8, 16 and 24 months post-randomization | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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