Mentalization-based treatment versus bona fide treatment for patients with borderline personality disorder in Germany (MAGNET): study protocol of a prospective, multi-centre randomized controlled trial
Abstract Background Borderline Personality Disorder (BPD) is a serious mental disorder. Mentalization-based treatment (MBT) is an evidence-based treatment for individuals with BPD. Specifically, MBT has previously been highlighted for its effectiveness regarding the reduction of suicidal and non-sui...
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2025-04-01
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| author | Sophie Hauschild Svenja Taubner Thorsten Vidalón Blachowiak Ulrike Dinger Harald Gündel Sabine C. Herpertz Jörg Rademacher Bernhard Strauss Timo Storck Ralitsa Vassileva Ina Burghaus Manuel Herbst Simiao Chen Christoph Nikendei Sebastian Euler Jana Volkert |
| author_facet | Sophie Hauschild Svenja Taubner Thorsten Vidalón Blachowiak Ulrike Dinger Harald Gündel Sabine C. Herpertz Jörg Rademacher Bernhard Strauss Timo Storck Ralitsa Vassileva Ina Burghaus Manuel Herbst Simiao Chen Christoph Nikendei Sebastian Euler Jana Volkert |
| author_sort | Sophie Hauschild |
| collection | DOAJ |
| description | Abstract Background Borderline Personality Disorder (BPD) is a serious mental disorder. Mentalization-based treatment (MBT) is an evidence-based treatment for individuals with BPD. Specifically, MBT has previously been highlighted for its effectiveness regarding the 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 within the German health care system, 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. 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 a period of two years. In the first year, patients will receive either MBT or BFT and will take part in continuous scientific assessments. Scientific assessments will continue after therapy completion up to a 12-month follow up. As primary outcome, crisis events will be assessed via ecological momentary assessment (EMA) in one week per month (four weekly assessments) during the first year, and in one week every three months during 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 and mediator variables will be assessed at several timepoints. Discussion 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. Trial registration NCT06018272, https://www.clinicaltrials.gov/ , August 30, 2023. |
| format | Article |
| id | doaj-art-c7c26b44c0744a08869b00a5badbdb36 |
| institution | OA Journals |
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| language | English |
| publishDate | 2025-04-01 |
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| series | BMC Psychiatry |
| spelling | doaj-art-c7c26b44c0744a08869b00a5badbdb362025-08-20T02:12:02ZengBMCBMC Psychiatry1471-244X2025-04-0125111910.1186/s12888-025-06809-0Mentalization-based treatment versus bona fide treatment for patients with borderline personality disorder in Germany (MAGNET): study protocol of a prospective, multi-centre randomized controlled trialSophie Hauschild0Svenja Taubner1Thorsten Vidalón Blachowiak2Ulrike Dinger3Harald Gündel4Sabine C. Herpertz5Jörg Rademacher6Bernhard Strauss7Timo Storck8Ralitsa Vassileva9Ina Burghaus10Manuel Herbst11Simiao Chen12Christoph Nikendei13Sebastian Euler14Jana Volkert15Institute for Psychosocial Prevention, University Hospital Heidelberg, University of HeidelbergInstitute for Psychosocial Prevention, University Hospital Heidelberg, University of HeidelbergInstitute for Psychosocial Prevention, University Hospital Heidelberg, University of HeidelbergDepartment of Psychosomatic Medicine and Psychotherapy, Medical Faculty, Heinrich-Heine University DüsseldorfClinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm, University of UlmDepartment of General Psychiatry, University Hospital Heidelberg, University of HeidelbergDepartment of Psychosomatic Medicine and Psychotherapy, Medical Faculty, Heinrich-Heine University DüsseldorfInstitute for Psychosocial Medicine, Psychotherapy and Psychooncology, University Hospital JenaDepartment of Clinical Psychology and Psychotherapy, Psychologische Hochschule BerlinCoordination Centre for Clinical Trials (KKS), Medical Faculty, University Hospital HeidelbergCoordination Centre for Clinical Trials (KKS), Medical Faculty, University Hospital HeidelbergCoordination Centre for Clinical Trials (KKS), Medical Faculty, University Hospital HeidelbergHeidelberg Institute of Global Health, University of HeidelbergDepartment for General Internal Medicine and Psychosomatics, University Hospital Heidelberg, University of HeidelbergDepartment of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital ZurichClinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm, University of UlmAbstract Background Borderline Personality Disorder (BPD) is a serious mental disorder. Mentalization-based treatment (MBT) is an evidence-based treatment for individuals with BPD. Specifically, MBT has previously been highlighted for its effectiveness regarding the 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 within the German health care system, 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. 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 a period of two years. In the first year, patients will receive either MBT or BFT and will take part in continuous scientific assessments. Scientific assessments will continue after therapy completion up to a 12-month follow up. As primary outcome, crisis events will be assessed via ecological momentary assessment (EMA) in one week per month (four weekly assessments) during the first year, and in one week every three months during 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 and mediator variables will be assessed at several timepoints. Discussion 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. Trial registration NCT06018272, https://www.clinicaltrials.gov/ , August 30, 2023.https://doi.org/10.1186/s12888-025-06809-0Borderline Personality DisorderMentalization-based therapyRandomized controlled trialHealth economyCrisis eventsEcological Momentary Assessment |
| spellingShingle | Sophie Hauschild Svenja Taubner Thorsten Vidalón Blachowiak Ulrike Dinger Harald Gündel Sabine C. Herpertz Jörg Rademacher Bernhard Strauss Timo Storck Ralitsa Vassileva Ina Burghaus Manuel Herbst Simiao Chen Christoph Nikendei Sebastian Euler Jana Volkert Mentalization-based treatment versus bona fide treatment for patients with borderline personality disorder in Germany (MAGNET): study protocol of a prospective, multi-centre randomized controlled trial BMC Psychiatry Borderline Personality Disorder Mentalization-based therapy Randomized controlled trial Health economy Crisis events Ecological Momentary Assessment |
| title | Mentalization-based treatment versus bona fide treatment for patients with borderline personality disorder in Germany (MAGNET): study protocol of a prospective, multi-centre randomized controlled trial |
| title_full | Mentalization-based treatment versus bona fide treatment for patients with borderline personality disorder in Germany (MAGNET): study protocol of a prospective, multi-centre randomized controlled trial |
| title_fullStr | Mentalization-based treatment versus bona fide treatment for patients with borderline personality disorder in Germany (MAGNET): study protocol of a prospective, multi-centre randomized controlled trial |
| title_full_unstemmed | Mentalization-based treatment versus bona fide treatment for patients with borderline personality disorder in Germany (MAGNET): study protocol of a prospective, multi-centre randomized controlled trial |
| title_short | Mentalization-based treatment versus bona fide treatment for patients with borderline personality disorder in Germany (MAGNET): study protocol of a prospective, multi-centre randomized controlled trial |
| title_sort | mentalization based treatment versus bona fide treatment for patients with borderline personality disorder in germany magnet study protocol of a prospective multi centre randomized controlled trial |
| topic | Borderline Personality Disorder Mentalization-based therapy Randomized controlled trial Health economy Crisis events Ecological Momentary Assessment |
| url | https://doi.org/10.1186/s12888-025-06809-0 |
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