Is outpatient Mentalization-Based Treatment (MBT) more effective compared to Bona-fide treatment (BFT) in Germany for patients with Borderline Personality Disorder? A prospective, multi-centre Randomized Controlled Trial (RCT) (MaGnet)

对于边缘性人格障碍患者，在德国门诊基于心理化的治疗 (MBT) 是否比善意治疗 (BFT) 更有效？

• 批准号: 500412881
• 负责人: Professorin Dr. Svenja Taubner
• 金额: --
• 依托单位: Klinik für Allgemeine Psychiatrie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/500412881?language=en
• 关键词: outpatient; Mentalization; Based; Treatment; MBT

BPD is a severe mental health issue with high individual and societal burden. Although, promising treatment approaches have been developed, there is still a high need to improve health care for BPD patients and to test for treatment efficacy. MaGnet is a 36 months prospective, multi-center, observer-blinded, national randomized controlled trial (RCT) to test the efficacy of two experimental interventions, Mentalization-Based-Treatment (MBT) vs. a control intervention (“bona fide treatment”, BFT) in patients with BPD in an outpatient setting. Main inclusion criteria will be BPD diagnosis, both sexes, ages 18 to 65 years and non-suicidal-self-injury (NSSI) or suicide attempts in the past two years with one in the past six months. At 5 recruiting centers across Germany N=544 BPD patients will be screened for eligibility and randomized into one of two arms. The treatment duration in MBT will be 12 months. BFT can be longer or shorter. The final sample for Intention-To-Treat analysis will comprise N=304 patients. Primary endpoint is crisis events of suicidal behavior and NSSI at 12-months follow-up. Secondary outcomes are cost-effectiveness, BPD and psychiatric symptom severity, general and interpersonal functioning, social adjustment, quality of life, changes in psychotropic medication and therapy retention. The goal of this trial is to confirm the experimental efficacy of an innovative, BPD-specific, easy-to-train and cost-effective treatment.

BPD是一种严重的心理健康问题，具有很高的个人和社会负担。尽管已经开发了有前景的治疗方法，但仍然非常需要改善BPD患者的健康护理并测试治疗功效。MaGnet是一项为期36个月的前瞻性、多中心、双盲、国家随机对照试验（RCT），旨在测试两种实验性干预措施（基于心理化的治疗（MBT）与对照干预措施（“善意治疗”，BFT））在门诊BPD患者中的疗效。主要入选标准将是BPD诊断，男女，年龄18至65岁，过去两年中无自杀性自伤（NSSI）或自杀企图，过去六个月内有一次。在德国的5家招募中心，将筛选N=544例BPD患者的合格性，并随机分配至两组之一。MBT的治疗持续时间为12个月。BFT可以长或短。意向治疗分析的最终样本将包括N=304例患者。主要终点是12个月随访时自杀行为和NSSI的危机事件。次要结果是成本效益，BPD和精神症状严重程度，一般和人际功能，社会适应，生活质量，精神药物和治疗保留的变化。这项试验的目的是确认一种创新的、BPD特异性的、易于培训的和具有成本效益的治疗方法的实验疗效。