Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany

NCT06018272 | Recruiting DMC

• 1 other identifier: 500412881
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 5

Brief Summary

Background: Borderline Personality Disorder (BPD) is a serious mental disorder. Mentalization-based treatment (MBT) is one evidence-based treatment for individuals with BPD. Specifically, MBT has been highlighted for its effectiveness in reduction of suicidal and non-suicidal self-injury (NSSI). Yet, randomized-controlled trials (RCT) on MBT in outpatient settings compared with bona fide treatment (BFT) are still scarce and none has been conducted in Germany. The primary objective of this RCT is to investigate whether outpatient MBT is more effective in the reduction of crisis events (incidences of NSSI and suicide attempts) compared with BFT (namely psychodynamic or cognitive-behavioural psychotherapy) in Germany. Secondary, MBT's efficacy will be investigated with regard to cost-effectiveness, general and interpersonal functioning, BPD and general symptom severity, social adjustment, quality of life, reduction in psychotropic medication and therapy retention. Additionally, moderator as well as common and treatment specific mediator variables will be investigated. Study Design/ Study Population/ Methods: Across 5 study sites in Germany, 304 individuals of all genders from age 18 to 65 with a BPD diagnosis and NSSI or suicide attempts in the past will be asked to participate in the study for two years. In the first year, patients will receive either MBT or BFT (psychodynamic or cognitive behavioural psychotherapy) and will take part in continuous scientific assessments. Scientific assessments will continue after therapy completion up to a 12-moth follow up. As primary outcome, crisis events will be assessed via ecological momentary assessment (EMA) four times a week once per month during the first year and once every three months in the second year. Number of crisis events up to 2 years post randomization will be compared between treatment arms using a log-linear regression model following an intention-to-treat approach. Secondary outcomes, such as borderline and general symptom severity, will be assessed at several timepoints. A within-trial cost-effectiveness analysis (CEA) will be conducted with a societal perspective. Clinical Trial Rationale: This study investigates efficacy of MBT as BPD specific treatment in an outpatient setting compared with BFT in Germany. Results of this study can address a treatment gap in the German healthcare system, and inform about health economic aspects of BPD treatment as well as mechanisms of psychotherapeutic change.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• change in crisis events assessed with Ecological Momentary Assessment with items based on the SHBQ (Gutierrez et al., 2001)

  composite score (non)suicidal self injury

  every second day during one week per month in the first year, and during one week every three months in the second year

Secondary Outcomes (14)

• Symptoms of Borderline Personality Disorder assessed with the IPDE (Loranger et al., 1997) and BSL-23 (Wolf et al., 2009)

  Day 0, Month 6, Month 12, Month 24; IPDE only at Month 24

• Change in psychiatric symptom severity assessed with the DASS- 21 (Lovibond & Lovibond, 1995)

  Day 0, Month 6, Month 12, Month 24

• Change in health and disability assessed with WHODAS 2.0 Short Form (Üstün et al., 2010)

  Day 0, Month 6, Month 12, Month 24

• Change in personality funcitioning assessed with LPFS-BF (Hutsebaut et al., 2016)

  Day 0, Month 6, Month 12, Month 24

• Change in personality traits assessed with PID5BF+M (Bach et al., 2020)

  Day 0, Month 6, Month 12, Month 24

Other Outcomes (20)

• Mentalizing as mediator of change assessed with the Certainty About Mental States Questionnaire (CAMSQ; Müller et al., 2021)

  Month 6, Month 12

• Therapeutic Agency Inventory (TAI; Huber et al., 2019)

  once a week in the first year and at Month 6 and Month 12

• Group Questionnaire - short (GQ; Jensen, 2016)

  once a week in the first year and at Month 6 and Month 12

Study Arms (2)

Mentalization-Based Treatment (MBT)

EXPERIMENTAL

Behavioral: Mentalization-Based Treatment (MBT)

Bona-Fide Treatment in Germany (BFT)

ACTIVE COMPARATOR

Behavioral: Bona-Fide Treatment in Germany (BFT)

Interventions

Mentalization-Based Treatment (MBT) BEHAVIORAL

Patients in MBT will receive a maximum of 58 sessions in total. Of those, 30 are weekly individual sessions. 28 sessions are weekly group sessions conducted by two therapists, and consisting of 8 introductory sessions of group psychoeducation followed by 20 group therapy sessions. The duration of MBT is 12 months. MBT is manualized and relies on validating the emotional experience of patients that aims to promote mentalizing. The proposed mechanism of change in MBT is to stabilize mentalizing in certain focus areas in order to create a psychic buffer between affect and behaviour to foster affect regulation, reduce impulsivity and promote functional supportive relationships.

Mentalization-Based Treatment (MBT)

Bona-Fide Treatment in Germany (BFT) BEHAVIORAL

Patients in BFT will receive one to two weekly sessions of Bona-Fide-Treatment (Psychodynamic Therapy, PT, or Cognitive Behavioural Therapy, CBT) conducted by community experts delivered as short-term psychotherapy (\<24 sessions) or long-term psychotherapy (\>24 sessions). BFT can be delivered as individual, group or a combination of individual and group treatment as stated in the German psychotherapy regulations.

Bona-Fide Treatment in Germany (BFT)

Eligibility Criteria

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

You may qualify if:

• Borderline Personality Disorder
• non-suicidal self injury or suicide attempts in the past two years as indicated by the IPDE item "repeated suicidal behaviours, gestures, threats or self-harm", one of which has occurred in the past six months

You may not qualify if:

• acute substance use disorder (exception: cannabis dependency)
• diagnosis of schizophrenia or schizotypal personality disorder
• bipolar I disorder (DSM-5)
• cognitive impairment (IQ\<80) or evidence of organic brain disorder
• BMI\<16.5
• serious medical condition that will require hospitalization within the next year (e.g. cancer)
• no sufficient German language abilities

Sponsors & Collaborators

• Heidelberg University: lead
• German Research Foundation: collaborator
• University Düsseldorf: collaborator
• Jena University Hospital: collaborator
• Universitätsklinikum Ulm: collaborator
• Psychologische Hochschule Berlin: collaborator

Study Sites (5)

Psychologische Hochschule Berlin

Berlin, Germany

RECRUITING

Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Düsseldorf

Düsseldorf, Germany

NOT YET RECRUITING

Heidelberg University

Heidelberg, 69115, Germany

RECRUITING

Institute for Psychosocial Medicine, Psychotherapy and Psychooncology

Jena, Germany

NOT YET RECRUITING

Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm

Ulm, Germany

NOT YET RECRUITING

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MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Mentalization-Based Therapy

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Svenja Taubner

  University Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Svenja Taubner, Prof.

CONTACT

+496221564701; svenja.taubner@med.uni-heidelberg.de

Sophie Hauschild, Dr.

CONTACT

sophie.hauschild@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. phil. Svenja Taubner

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 30, 2023
• Study Start: February 28, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)