The Short-Term MBT Project

NCT03677037 | Completed Phase 3 DMC

• 1 other identifier: H-18023136
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

mentalization-based therapy; borderline personality disorder; randomized clinical trial; psychotherapy research; treatment intensity

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (4)

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

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

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

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

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

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

• Change in amount of self-harm incidents

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

Other Outcomes (1)

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

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

Study Arms (2)

Short-term MBT

EXPERIMENTAL

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

Long-term MBT

ACTIVE COMPARATOR

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

Interventions

Short-term MBT OTHER

Short-term mentalization-based therapy

Short-term MBT

Long-term MBT OTHER

Long-term mentalization-based therapy

Long-term MBT

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• University of Copenhagen: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (1)

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

Gentofte Municipality, 2820, Denmark

Location

Related Publications (5)

• Juul S, Jakobsen JC, Hestbaek E, Jorgensen CK, Olsen MH, Rishede M, Frandsen FW, Bo S, Lunn S, Poulsen S, Sorensen P, Bateman A, Simonsen S. Short-Term versus Long-Term Mentalization-Based Therapy for Borderline Personality Disorder: A Randomized Clinical Trial (MBT-RCT). Psychother Psychosom. 2023;92(5):329-339. doi: 10.1159/000534289. Epub 2023 Nov 7.

  PMID: 37935133 DERIVED

• 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.

  PMID: 34321051 DERIVED

• 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.

  PMID: 32880104 DERIVED

• 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.

  PMID: 32368793 DERIVED

• 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.

  PMID: 30953536 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Sebastian Simonsen, PhD

  Sponsor-Investigator

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 19, 2018
• Study Start: September 24, 2018
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

DK (1)