Clinical trial NCT03677037: The Short-Term MBT Project
Official title: Short-term Versus Long-term Mentalization-based Therapy for Outpatients With Subthreshold or Diagnosed Borderline Personality Disorder: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Borderline Personality Disorder
Keywords: mentalization-based therapy
borderline personality disorder
randomized clinical trial
psychotherapy research
treatment intensity
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
First posted: 2018-09-19
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview
timeFrame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Secondary outcomes:
measure: Change in functional impairmment assessed with the Work and Social Adjustment Scale (WSAS)
timeFrame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
measure: Change in quality of life assessed with the Short-Form Health Survey 36 (SF-36)
timeFrame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
measure: Change in global functioning assessed with the Global Assessment of Functioning (GAF)
timeFrame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
measure: Change in amount of self-harm incidents
timeFrame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Other outcomes:
measure: Change in psychiatric symptom distress assessed with the Symptom Checklist 90 (SCL-90)
timeFrame: Assessed at baseline, and at 8, 16 and 24 months post-randomization
Locations:
city: Gentofte
country: Denmark
facility: Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark
Study officials:
affiliation: Sponsor-Investigator
name: Sebastian Simonsen, PhD
role: STUDY_DIRECTOR
References:
citation: Juul S, Simonsen S, Poulsen S, Lunn S, Sorensen P, Bateman A, Jakobsen JC. Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT). Trials. 2021 Jul 28;22(1):497. doi: 10.1186/s13063-021-05450-y.
citation: Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
citation: Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
citation: Juul S, Lunn S, Poulsen S, Sorensen P, Salimi M, Jakobsen JC, Bateman A, Simonsen S. Short-term versus long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder: a protocol for a randomized clinical trial. Trials. 2019 Apr 5;20(1):196. doi: 10.1186/s13063-019-3306-7.