Comparing Mentalization-Based Treatment and Standard Therapy for Borderline Personality Disorder in Germany
Mentalisierungsbasierte Therapie Versus Bona-fide-Therapie für Patient:Innen Mit Borderline-Persönlichkeitsstörung in Deutschland (MaGnet): Eine Prospektive, Multizentrische Randomisiert-kontrollierte Studie Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany (MAGNET): a Prospective, Multi-centre Randomized Controlled Trial
This study is testing if a new type of therapy called Mentalization-Based Treatment can help people with Borderline Personality Disorder in Germany feel better and have fewer crises compared to standard therapy options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Heidelberg University Academic / other |
| Locations | 5 sites (Berlin and 4 other locations) |
| Trial ID | NCT06018272 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Mentalization-Based Treatment (MBT) compared to bona fide treatments (BFT) such as psychodynamic or cognitive-behavioral psychotherapy for patients with Borderline Personality Disorder (BPD) in Germany. The study aims to determine if MBT can more effectively reduce crisis events, including non-suicidal self-injury and suicide attempts, while also assessing its impact on overall functioning, symptom severity, and cost-effectiveness. Participants will be monitored for changes in their mental health and quality of life over the course of the treatment. This randomized-controlled trial addresses a significant gap in existing research on outpatient MBT in Germany.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Borderline Personality Disorder who have experienced non-suicidal self-injury or suicide attempts in the past two years.
Not a fit: Patients with acute substance use disorders (except cannabis dependency), schizophrenia, bipolar I disorder, or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with Borderline Personality Disorder, potentially reducing self-harm and improving overall mental health outcomes.
How similar studies have performed: While there is limited research on MBT in outpatient settings in Germany, similar studies in other regions have shown promising results for MBT in treating BPD.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Berlin and 4 other locations
- Psychologische Hochschule Berlin — Berlin, Germany (Recruiting)
- Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Düsseldorf — Düsseldorf, Germany (Not_yet_recruiting)
- Heidelberg University — Heidelberg, 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)
Study contacts
- Principal investigator: Svenja Taubner — University Heidelberg
- Study coordinator: Svenja Taubner, Prof.
- Email: svenja.taubner@med.uni-heidelberg.de
- Phone: +496221564701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.