The Short-Term MBT Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-24

Study Completion Date

2023-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Short-term MBT

Intervention Type OTHER

Short-term mentalization-based therapy

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.

Group Type ACTIVE_COMPARATOR

Long-term MBT

Intervention Type OTHER

Long-term mentalization-based therapy

Interventions

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Short-term MBT

Short-term mentalization-based therapy

Intervention Type OTHER

Long-term MBT

Long-term mentalization-based therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years
* Personality disorder(s) considered to be primary diagnosis/diagnoses

* A minimum of four DSM-5 criteria for borderline personality disorder
* Written informed consent

Exclusion Criteria

* 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

\- Lack of informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No