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Completed

NCT Number: NCT03677037

The Short-Term MBT Project

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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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark

Gentofte Municipality, 2820, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short-term MBT

Other

Short-term mentalization-based therapy

Long-term MBT

Other

Long-term mentalization-based therapy

Primary outcomes

  1. Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview

    Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization

    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.

Secondary outcomes

  1. Change in functional impairmment assessed with the Work and Social Adjustment Scale (WSAS)

    Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization

    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.

  2. Change in quality of life assessed with the Short-Form Health Survey 36 (SF-36)

    Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization

    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).

  3. Change in global functioning assessed with the Global Assessment of Functioning (GAF)

    Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization

    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.

  4. Change in amount of self-harm incidents

    Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization

    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.

Other outcomes

  1. Change in psychiatric symptom distress assessed with the Symptom Checklist 90 (SCL-90)

    Time frame: Assessed at baseline, and at 8, 16 and 24 months post-randomization

    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.

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • University of Copenhagen

Registry information

Official study title

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

Acronym: MBT-RCT

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Sep 19, 2018
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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