A Phase 3 interventional study of Short-term MBT and Long-term MBT in Borderline Personality Disorder, sponsored by Mental Health Services in the Capital Region, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by Mental Health Services in the Capital Region, Denmark · Phase 3, Interventional, and Treatment
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.
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.
336 studies on the registry are indexed under Personality Disorders; 48 are open to participants now.
This study's enrollment of 166 is above the median of 75 across 229 interventional studies indexed under Personality Disorders.
Browse Personality Disorders studies →Mental Health Services in the Capital Region, Denmark is the lead sponsor of 51 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria exclusive to the Outpatient Clinic
Inclusion Criteria exclusive to the trial:
Exclusion Criteria exclusive to the Outpatient Clinic:
Exclusion Criteria exclusive to the trial:
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
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
Short-term mentalization-based therapy
Long-term mentalization-based therapy
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.
Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
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.
Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Plan to share: Undecided
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Mental Health Services in the Capital Region, Denmark