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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 304
- 试验地点
- 6
- 主要终点
- change in crisis events assessed with Ecological Momentary Assessment with items based on the SHBQ (Gutierrez et al., 2001)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
change in crisis events assessed with Ecological Momentary Assessment with items based on the SHBQ (Gutierrez et al., 2001)
时间窗: every second day during one week per month in the first year, and during one week every three months in the second year
composite score (non)suicidal self injury
次要结局
- Change in quality of life assessed with EQ-5D-5L (Herdman et al., 2011; EuroQol Research Foundation, 2019)(Day 0, Month 6, Month 12, Month 24)
- Change in Interoceptive Body Awareness with MAIA-2 (Mehling et al., 2018)(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)(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 emotional reactions to social exclusion, rejection and relational devaluation with SPQ (Stangier et al., 2021)(Day 0, Month 6, Month 12, Month 24)
- Change in threat hypersensitivity assessed with emotion classification task (Honecker et al., 2021)(Day 0, Month 6, Month 12, Month 24)
- Change in social adjustment assessed with WSAS (Marks, 1986)(Day 0, Month 6, Month 12, Month 24)
- 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 personality traits assessed with PID5BF+M (Bach et al., 2020)(Day 0, Month 6, Month 12, Month 24)
- Heath Care utilization with an adapted version of the AD-SUS (Kuyken et al., 2015)(Day 0, Month 6, Month 12, Month 24)
- Change in acute dissociative symptoms with Dissociation-Tension Scale-4 (DSS-4; Stiglmayr et al., 2003)(Day 0, Month 6, Month 12, 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 trait anger assessed with STAXI-2 (Spielberger, 1999)(Day 0, Month 6, Month 12, Month 24)
研究者
Svenja Taubner
Prof. Dr. phil. Svenja Taubner
Heidelberg University