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The Short-Term MBT Project (MBT-RCT)

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ClinicalTrials.gov Identifier: NCT03677037
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : October 5, 2018
Sponsor:
Collaborators:
University of Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Other: Short-term MBT Other: Long-term MBT Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-term Versus Long-term Mentalization-based Therapy for Outpatients With Subthreshold or Diagnosed Borderline Personality Disorder: a Randomized Clinical Trial
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: Short-term MBT
Short-term mentalization-based therapy

Active Comparator: 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.
Other: Long-term MBT
Long-term mentalization-based therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677037


Contacts
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Contact: Sophie Juul, M.sc. 004538645324 sophie.juul@regionh.dk

Locations
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Denmark
Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark Recruiting
Gentofte, Denmark, 2820
Contact: Sophie Juul, M.Sc.    004538645324    sophie.juul@regionh.dk   
Principal Investigator: Sophie Juul, M.sc         
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
University of Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators
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Study Director: Sebastian Simonsen, PhD Sponsor-Investigator

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT03677037     History of Changes
Other Study ID Numbers: H-18023136
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mental Health Services in the Capital Region, Denmark:
mentalization-based therapy
borderline personality disorder
randomized clinical trial
psychotherapy research
treatment intensity

Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders