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)
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)
批准号:
500412881
负责人:
Professorin Dr. Svenja Taubner
金额:
$0.0万
依托单位国家:
德国
项目类别:
Clinical Trials
财政年份:
--
资助国家:
德国
项目状态:
未结题
起止时间:
中文摘要
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英文摘要
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.
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