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)

BPD是一个严重的心理健康问题，具有很高的个人和社会负担。尽管已经开发出了有希望的治疗方法，但仍迫切需要改善BPD患者的医疗保健并测试治疗效果。Magic是一项为期36个月的前瞻性、多中心、观察者盲的全国性随机对照试验(RCT)，旨在测试两种实验性干预措施在门诊环境中对BPD患者的疗效，基于精神化的治疗(MBT)与对照干预(“真诚治疗”，BFT)。主要入选标准将是BPD诊断，男女，年龄18至65岁，以及过去两年内非自杀自残(NSSI)或自杀未遂，其中一人在过去六个月内。在德国各地的5个招募中心，N=544桶/日的患者将接受资格筛选，并随机分成两组。MBT的疗程为12个月。BFT可以更长，也可以更短。意向治疗分析的最终样本将包括N=304名患者。主要终点是自杀行为的危机事件和12个月随访时的NSSI。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、精神药物的变化和治疗保留。这项试验的目标是确认一种创新的、针对BPD的、易于培训和成本效益高的治疗方法的实验疗效。

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.