The Short-Term MBT Project (MBT-RCT)

Mental Health Services in the Capital Region, Denmark

Status and phase: Completed; Phase 3

Conditions: Borderline Personality Disorder

Treatments: Other: Long-term MBT; Other: Short-term MBT

Study type: Interventional

Funder types: Other

Identifiers

NCT03677037

H-18023136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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166 participants in 2 patient groups

Short-term MBT

Experimental group

Description:

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.

Treatment:

Other: Short-term MBT

Long-term MBT

Active Comparator group

Description:

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.

Treatment:

Other: Long-term MBT