Laurenssen Elisabeth M P, Westra Dieuwertje, Kikkert Martijn J, Noom Marc J, Eeren Hester V, van Broekhuyzen Anna J, Peen Jaap, Luyten Patrick, Busschbach Jan J V, Dekker Jack J M
Viersprong Institute for Studies on Personality Disorders (VISPD), Halsteren, The Netherlands.
BMC Psychiatry. 2014 May 22;14:149. doi: 10.1186/1471-244X-14-149.
Severe borderline personality disorder is associated with a very high psychosocial and economic burden. Current treatment guidelines suggest that several manualized treatments, including day hospital Mentalization-Based Treatment (MBT-DH), are effective in these patients. However, only two randomized controlled trials have compared manualized MBT-DH with treatment as usual. Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH, the possible influence of researcher allegiance in one of the trials, and potential problems with the generalization of findings to mental health systems in other countries, this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands.
METHODS/DESIGN: The trial is being conducted at two sites in The Netherlands. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual. The MBT-DH program consists of a maximum of 18 months' intensive treatment, followed by a maximum of 18 months of maintenance therapy. Specialist treatment as usual is provided by the City Crisis Service in Amsterdam, a service that specializes in treating patients with personality disorders, offering manualized, non-MBT interventions including family interventions, Linehan training, social skills training, and pharmacotherapy, without a maximum time limit. Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment. The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index. Secondary outcome measures include parasuicidal behaviour, symptomatic distress, social and interpersonal functioning, personality functioning, attachment, capacity for mentalizing and quality of life. Cost-effectiveness is assessed in terms of the cost per quality-adjusted life year. Outcomes will be analyzed using multilevel analyses based on intention-to-treat principles.
Severe borderline personality disorder is a serious psychological disorder that is associated with high burden. This multi-site randomized trial will provide further data concerning the efficacy and cost-effectiveness of MBT-DH for these patients.
NTR2175.
重度边缘型人格障碍会带来极高的心理社会和经济负担。当前的治疗指南表明，包括日间医院基于心智化的治疗（MBT-DH）在内的几种手册化治疗方法对这些患者有效。然而，仅有两项随机对照试验将手册化的MBT-DH与常规治疗进行了比较。鉴于支持MBT-DH疗效和成本效益的数据相对较少，其中一项试验中研究人员忠诚度可能产生的影响，以及研究结果推广至其他国家心理健康系统时可能存在的问题，这项多中心随机试验旨在调查在荷兰，与常规手册化专科治疗相比，手册化MBT-DH的疗效和成本效益。
方法/设计：该试验在荷兰的两个地点进行。符合《精神疾病诊断与统计手册》第四版修订版（DSM-IV-TR）边缘型人格障碍诊断标准且边缘型人格障碍严重程度指数得分≥20分的患者被随机分配至MBT-DH组或常规治疗组。MBT-DH项目包括最长18个月的强化治疗，随后是最长18个月的维持治疗。常规专科治疗由阿姆斯特丹市危机服务中心提供，该服务专门治疗人格障碍患者，提供手册化的非MBT干预措施，包括家庭干预、莱因汉训练、社交技能训练和药物治疗，且无时间限制。患者在基线时接受评估，随后在治疗开始后的36个月内每6个月评估一次。主要结局指标是通过边缘型人格障碍严重程度指数评估的边缘型人格障碍表现的频率和严重程度。次要结局指标包括准自杀行为、症状困扰、社会和人际功能、人格功能、依恋、心智化能力和生活质量。成本效益根据每质量调整生命年的成本进行评估。将根据意向性分析原则使用多水平分析对结局进行分析。
重度边缘型人格障碍是一种严重的心理障碍，负担沉重。这项多中心随机试验将为MBT-DH对这些患者的疗效和成本效益提供进一步的数据。
NTR2175。
