The Short-Term MBT Project

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03677037
Study type	Interventional
Source	Mental Health Services in the Capital Region, Denmark
Contact
Status	Completed
Phase	Phase 3
Start date	September 24, 2018
Completion date	December 15, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04856449` - DBT Skills Plus EMDR for BPD and Trauma	N/A
Active, not recruiting	`NCT04587518` - Five Factor Model Treatment for Borderline Personality Disorder	N/A
Recruiting	`NCT05651295` - A Precision Medicine Approach to Target Engagement for Emotion Regulation	N/A
Not yet recruiting	`NCT05989529` - Delving Into Borderline Personality Disorder Clinical Trial Experiences
Completed	`NCT02518906` - Evaluation of AIT Study	N/A
Completed	`NCT02068326` - MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial	N/A
Recruiting	`NCT04296604` - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations	N/A
Completed	`NCT02108990` - Acetaminophen and Social Processes	Phase 2
Terminated	`NCT02149823` - Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations	Phase 1
Completed	`NCT02988037` - Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study	N/A
Completed	`NCT01635556` - Evaluation of a Modified Dialectical Behavior Therapy Program	N/A
Not yet recruiting	`NCT01683136` - Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder	N/A
Completed	`NCT02397031` - Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder	N/A
Terminated	`NCT01212588` - Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD)	Phase 2
Terminated	`NCT01103180` - Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder	Phase 2
Terminated	`NCT00539188` - N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD	Phase 2
Recruiting	`NCT05398627` - Neurofeedback for Borderline Personality Disorder	N/A
Recruiting	`NCT03994510` - SHame prOpensity in bOrderline Personality Disorder	N/A
Recruiting	`NCT06005129` - Personality Change Study for Borderline Personality Disorder	N/A
Recruiting	`NCT06406972` - Brief Admission by Self-referral for Individuals With Self-harm: Effects on Compulsory Care

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Short-Term MBT Project — MBT-RCT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms