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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term MBT | Experimental | 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. |
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| Long-term MBT | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short-term MBT | Other | Short-term mentalization-based therapy |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
- Lack of informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Simonsen, PhD | Sponsor-Investigator | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark | Gentofte Municipality | 2820 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42363615 | Derived | Harpoth TSD, Juul S, Olsen MH, Hestbaek E, Kamp CB, Rishede M, Frandsen FW, Bo S, Poulsen S, Sorensen P, Bateman A, Jakobsen JC, Simonsen S. Effects of Short-Term Versus Long-Term Mentalization-Based Therapy on Psychiatric Symptoms in Outpatients With Borderline Personality Disorder: Exploratory Results From a Randomized Clinical Trial. Personal Ment Health. 2026 Aug;20(3):e70088. doi: 10.1002/pmh.70088. | |
| 37935133 |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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| Long-term MBT |
| Other |
Long-term mentalization-based therapy |
|
| 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 |
| Derived |
| Juul S, Jakobsen JC, Hestbaek E, Jorgensen CK, Olsen MH, Rishede M, Frandsen FW, Bo S, Lunn S, Poulsen S, Sorensen P, Bateman A, Simonsen S. Short-Term versus Long-Term Mentalization-Based Therapy for Borderline Personality Disorder: A Randomized Clinical Trial (MBT-RCT). Psychother Psychosom. 2023;92(5):329-339. doi: 10.1159/000534289. Epub 2023 Nov 7. |
| 34321051 | Derived | Juul S, Simonsen S, Poulsen S, Lunn S, Sorensen P, Bateman A, Jakobsen JC. 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 Jul 28;22(1):497. doi: 10.1186/s13063-021-05450-y. |
| 32880104 | Derived | Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3. |
| 32368793 | Derived | Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2. |
| 30953536 | Derived | Juul S, Lunn S, Poulsen S, Sorensen P, Salimi M, Jakobsen JC, Bateman A, Simonsen S. Short-term versus long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder: a protocol for a randomized clinical trial. Trials. 2019 Apr 5;20(1):196. doi: 10.1186/s13063-019-3306-7. |