Department of Clinical Psychological Science, Faculty of Psychology, Maastricht University, Maastricht, The Netherlands.
BMC Public Health. 2012 Jan 24;12:75. doi: 10.1186/1471-2458-12-75.
Despite international guidelines describing psychotherapy as first choice for people with personality disorders (PDs), well-designed research on the effectiveness and cost-effectiveness of psychotherapy for PD is scarce. Schema therapy (ST) is a specific form of psychological treatment that proved to be effective for borderline PD. Randomized controlled studies on the effectiveness of ST for other PDs are lacking. Another not yet tested new specialized treatment is Clarification Oriented Psychotherapy (COP). The aim of this project is to perform an effectiveness study as well as an economic evaluation study (cost effectiveness as well as cost-utility) comparing ST versus COP versus treatment as usual (TAU). In this study, we focus on avoidant, dependent, obsessive-compulsive, paranoid, histrionic and narcissistic PD.
METHODS/DESIGN: In a multicentered randomized controlled trial, ST, and COP as an extra experimental condition, are compared to TAU. Minimal 300 patients are recruited in 12 mental health institutes throughout the Netherlands, and receive an extensive screening prior to enrolment in the study. When eligible, they are randomly assigned to one of the intervention groups. An economic evaluation and a qualitative research study on patient and therapist perspectives on ST are embedded in this trial. Outcome assessments (both for clinical effectiveness and economic evaluation) take place at 6,12,18,24 and 36 months after start of treatment. Primary outcome is recovery from PD; secondary measures include general psychopathological complaints, social functioning and quality of life. Data for the cost-effectiveness and cost-utility analyses are collected by using a retrospective cost interview. Information on patient and therapist perspectives is gathered using in-depth interviews and focus groups, and focuses on possible helpful and impeding aspects of ST.
This trial is the first to compare ST and COP head-to-head with TAU for people with a cluster C, paranoid, histrionic and/or narcissistic PD. By combining clinical effectiveness data with an economic evaluation and with direct information from primary stakeholders, this trial offers a complete and thorough view on ST as a contribution to the improvement of treatment for this PD patient group.
Netherlands Trial Register (NTR): NTR566.
尽管国际指南将心理治疗描述为人格障碍（PD）患者的首选治疗方法，但针对心理治疗的有效性和成本效益的精心设计研究却很少。图式治疗（ST）是一种特定形式的心理治疗，已被证明对边缘型 PD 有效。缺乏针对其他 PD 进行 ST 有效性的随机对照研究。另一种尚未经过测试的新专业治疗方法是澄清导向心理治疗（COP）。本项目的目的是进行一项有效性研究以及一项经济评估研究（成本效益以及成本效用），比较 ST 与 COP 与常规治疗（TAU）。在这项研究中，我们专注于回避型、依赖型、强迫型、偏执型、表演型和自恋型 PD。
方法/设计：在一项多中心随机对照试验中，ST 和 COP 作为额外的实验组，与 TAU 进行比较。在荷兰的 12 家心理健康机构中招募了至少 300 名患者，并在入组前进行了广泛的筛查。符合条件的患者被随机分配到干预组之一。该试验还嵌入了一项经济评估和一项关于患者和治疗师对 ST 的看法的定性研究。结果评估（包括临床有效性和经济评估）在治疗开始后 6、12、18、24 和 36 个月进行。主要结局是 PD 康复；次要指标包括一般心理病理症状、社会功能和生活质量。成本效益和成本效用分析的数据通过回顾性成本访谈收集。通过深入访谈和焦点小组收集关于患者和治疗师观点的信息，重点关注 ST 的有益和阻碍方面。
这是第一项比较 ST 和 COP 与 TAU 治疗 Cluster C、偏执型、表演型和/或自恋型 PD 的头对头试验。通过将临床有效性数据与经济评估以及主要利益相关者的直接信息相结合，该试验全面、彻底地展示了 ST 作为改善该 PD 患者群体治疗方法的贡献。
荷兰试验注册（NTR）：NTR566。
