Condition: Borderline Personality Disorder · Sponsor: Heidelberg University
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. Scie…
This description comes directly from the study's public registry record.
Svenja Taubner, Prof. · +496221564701 · svenja.taubner@med.uni-heidelberg.de
Sophie Hauschild, Dr. · sophie.hauschild@med.uni-heidelberg.de
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT06018272