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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Mentalization-Based Treatment (MBT)
  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
• Поведенческое Bona-Fide Treatment in Germany (BFT)
  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.

Первичные конечные точки

• change in crisis events assessed with Ecological Momentary Assessment with items based on the SHBQ (Gutierrez et al., 2001) [Срок оценки: every second day during one week per month in the first year, and during one week every three months in the second year]

Вторичные конечные точки (12)

• Symptoms of Borderline Personality Disorder assessed with the IPDE (Loranger et al., 1997) and BSL-23 (Wolf et al., 2009) [Срок оценки: 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) [Срок оценки: Day 0, Month 6, Month 12, Month 24]
• Change in health and disability assessed with WHODAS 2.0 Short Form (Üstün et al., 2010) [Срок оценки: Day 0, Month 6, Month 12, Month 24]
• Change in personality funcitioning assessed with LPFS-BF (Hutsebaut et al., 2016) [Срок оценки: Day 0, Month 6, Month 12, Month 24]
• Change in personality traits assessed with PID5BF+M (Bach et al., 2020) [Срок оценки: Day 0, Month 6, Month 12, Month 24]
• Change in threat hypersensitivity assessed with emotion classification task (Honecker et al., 2021) [Срок оценки: Day 0, Month 6, Month 12, Month 24]
• Change in quality of life assessed with EQ-5D-5L (Herdman et al., 2011; EuroQol Research Foundation, 2019) [Срок оценки: Day 0, Month 6, Month 12, Month 24]
• Change in trait anger assessed with STAXI-2 (Spielberger, 1999) [Срок оценки: Day 0, Month 6, Month 12, Month 24]
• Change in social adjustment assessed with WSAS (Marks, 1986) [Срок оценки: Day 0, Month 6, Month 12, Month 24]
• Change in emotional reactions to social exclusion, rejection and relational devaluation with SPQ (Stangier et al., 2021) [Срок оценки: Day 0, Month 6, Month 12, Month 24]
• Change in Interoceptive Body Awareness with MAIA-2 (Mehling et al., 2018) [Срок оценки: Day 0, Month 6, Month 12, Month 24]
• Changes in medication with self-report of medication prescription via adapted version of AD-SUS (Kuyken et al., 2015) [Срок оценки: Day 0, Month 6, Month 12, Month 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Германия · 5 центров

• Psychologische Hochschule Berlin — Berlin
• Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Düsseldorf — Düsseldorf
• Heidelberg University — Heidelberg
• Institute for Psychosocial Medicine, Psychotherapy and Psychooncology — Jena
• Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm — Ulm

Публикации

• Bateman A, Fonagy P. Mentalization based treatment for borderline personality disorder. World Psychiatry. 2010 Feb;9(1):11-5. doi: 10.1002/j.2051-5545.2010.tb00255.x. PMID 20148147
• Bateman A, Fonagy P. Effectiveness of partial hospitalization in the treatment of borderline personality disorder: a randomized controlled trial. Am J Psychiatry. 1999 Oct;156(10):1563-9. doi: 10.1176/ajp.156.10.1563. PMID 10518167
• Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1355-64. doi: 10.1176/appi.ajp.2009.09040539. Epub 2009 Oct 15. PMID 19833787
• Jorgensen CR, Freund C, Boye R, Jordet H, Andersen D, Kjolbye M. Outcome of mentalization-based and supportive psychotherapy in patients with borderline personality disorder: a randomized trial. Acta Psychiatr Scand. 2013 Apr;127(4):305-17. doi: 10.1111/j.1600-0447.2012.01923.x. Epub 2012 Aug 17. PMID 22897123
• Laurenssen EMP, Luyten P, Kikkert MJ, Westra D, Peen J, Soons MBJ, van Dam AM, van Broekhuyzen AJ, Blankers M, Busschbach JJV, Dekker JJM. Day hospital mentalization-based treatment v. specialist treatment as usual in patients with borderline personality disorder: randomized controlled trial. Psychol Med. 2018 Nov;48(15):2522-2529. doi: 10.1017/S0033291718000132. Epub 2018 Feb 26. PMID 29478425
• Rossouw TI, Fonagy P. Mentalization-based treatment for self-harm in adolescents: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Dec;51(12):1304-1313.e3. doi: 10.1016/j.jaac.2012.09.018. PMID 23200287
• Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2. PMID 32368793
• Wittchen H-U, Zaudig M, Fydrich T. Strukturiertes Klinisches Interview für DSM-IV (SKID I und SKID II). Göttingen: Hogrefe; 1997. https://doi.org/10.1026//0084-5345.28.1.68.

Идентификаторы

NCT: NCT06018272 · 500412881

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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