The Short-Term MBT Project

Borderline Personality Disorder Clinical Trial

— MBT-RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677037
• Other study ID #: H-18023136
• Status: Completed
• Phase: Phase 3
• Start date: September 24, 2018
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Other:
• Short-term MBT
Short-term mentalization-based therapy
• Long-term MBT
Long-term mentalization-based therapy

Locations

Country	Name	City	State
Denmark	Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark	Gentofte

Sponsors (3)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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