Laurenssen Elisabeth M P, Smits Maaike L, Bales Dawn L, Feenstra Dine J, Eeren Hester V, Noom Marc J, Köster Maartje A, Lucas Zwaan, Timman Reinier, Dekker Jack J M, Luyten Patrick, Busschbach Jan J V, Verheul Roel
Viersprong Institute for Studies on Personality Disorders (VISPD), Halsteren, the Netherlands.
Arkin, Amsterdam, the Netherlands.
BMC Psychiatry. 2014 Nov 18;14:301. doi: 10.1186/s12888-014-0301-0.
Borderline personality disorder (BPD) is associated with a high socioeconomic burden. Although a number of evidence-based treatments for BPD are currently available, they are not widely disseminated; furthermore, there is a need for more research concerning their efficacy and cost-effectiveness. Such knowledge promises to lead to more efficient use of resources, which will facilitate the effective dissemination of these costly treatments. This study focuses on the efficacy and cost-effectiveness of Mentalization-Based Treatment (MBT), a manualized treatment for patients with BPD. Studies to date have either investigated MBT in a day hospitalization setting (MBT-DH) or MBT offered in an intensive outpatient setting (MBT-IOP). No trial has compared the efficacy and cost-effectiveness of these MBT programmes. As both interventions differ considerably in terms of intensity of treatment, and thus potentially in terms of efficacy and cost-effectiveness, there is a need for comparative trials. This study therefore sets out to investigate the efficacy and cost-effectiveness of MBT-DH versus MBT-IOP in patients with BPD. A secondary aim is to investigate the association between baseline measures and outcome, which might improve treatment selection and thus optimize efficacy and cost-effectiveness.
METHODS/DESIGN: A multicentre randomized controlled trial comparing MBT-DH versus MBT-IOP in severe BPD patients. Patients are screened for BPD using the Structured Clinical Interview for DSM-IV Axis II Personality Disorders, and are assessed before randomization, at the start of treatment and 6, 12, 18, 24, 30 and 36 months after the start of treatment. Patients who refuse to participate will be offered care as usual in the same treatment centre. The primary outcome measure is symptom severity as measured by the Brief Symptom Inventory. Secondary outcome measures include parasuicidal behaviour, depression, substance use, social, interpersonal, and personality functioning, attachment, mentalizing capacities, and quality of life. All analyses will be conducted based on the intention-to-treat principle. Cost-effectiveness will be calculated based on costs per quality-adjusted life-year.
This multisite randomized trial will provide data to refine criteria for treatment selection for severe BPD patients and promises to optimize (cost-)effectiveness of the treatment of BPD patients.
NTR2292 . Registered 16 April 2010.
边缘型人格障碍（BPD）会带来较高的社会经济负担。尽管目前有一些基于证据的BPD治疗方法，但它们并未得到广泛传播；此外，对于这些治疗方法的疗效和成本效益还需要进行更多研究。此类知识有望带来资源的更有效利用，这将有助于有效推广这些成本高昂的治疗方法。本研究聚焦于基于心智化的治疗（MBT）的疗效和成本效益，MBT是一种针对BPD患者的标准化治疗方法。迄今为止的研究要么在日间住院环境中调查MBT（MBT-DH），要么在强化门诊环境中提供MBT（MBT-IOP）。尚无试验比较过这些MBT方案的疗效和成本效益。由于这两种干预措施在治疗强度方面差异很大，因此在疗效和成本效益方面可能也存在差异，所以需要进行比较试验。因此，本研究旨在调查MBT-DH与MBT-IOP对BPD患者的疗效和成本效益。第二个目标是调查基线测量与结果之间的关联，这可能会改善治疗选择，从而优化疗效和成本效益。
方法/设计：一项多中心随机对照试验，比较MBT-DH与MBT-IOP对重度BPD患者的效果。使用《精神疾病诊断与统计手册》第四版轴II人格障碍的结构化临床访谈对患者进行BPD筛查，并在随机分组前、治疗开始时以及治疗开始后的6、12、18、24、30和36个月进行评估。拒绝参与的患者将在同一治疗中心接受常规护理。主要结局指标是通过简明症状量表测量的症状严重程度。次要结局指标包括准自杀行为、抑郁、物质使用、社交、人际和人格功能、依恋、心智化能力和生活质量。所有分析将基于意向性分析原则进行。成本效益将根据每质量调整生命年的成本来计算。
这项多中心随机试验将提供数据，以完善重度BPD患者的治疗选择标准，并有望优化BPD患者治疗的（成本）效益。
NTR2292。于2010年4月16日注册。
