Department of Clinical Psychology, University of Amsterdam, PO Box 15933, Amsterdam, 1001 NK, the Netherlands.
Department of medical and clinical psychology, Tilburg University, Tilburg, the Netherlands.
BMC Psychiatry. 2022 Oct 8;22(1):637. doi: 10.1186/s12888-022-04248-9.
Given the high prevalence of Cluster-C Personality Disorders (PDs) in clinical populations, disease burden, high societal costs and poor prognosis of comorbid disorders, a major gain in health care can be achieved if Cluster-C PDs are adequately treated. The only controlled cost-effectiveness study published so far found Individual Schema Therapy (IST) to be superior to Treatment as Usual (TAU). Group ST (GST) might improve cost-effectiveness as larger numbers can be treated in (>50%) less time compared to IST. However, to date there is no RCT supporting its (cost-) effectiveness. The overall aim of this study is to assess the evidence for GST for Cluster-C PDs and to improve treatment allocation for individual patients. Three main questions are addressed: 1) Is GST for Cluster-C PDs (cost-)effective compared to TAU? 2) Is GST for Cluster-C PDs (cost-) effective compared to IST? 3) Which patient-characteristics predict better response to GST, IST, or TAU?
In a multicenter RCT, the treatment conditions GST, IST, and TAU are compared in 378 Cluster-C PD patients within 10 sites. GST and IST follow treatment protocols and are completed within 1 year. TAU is the optimal alternative treatment available at the site according to regular procedures. Severity of the Cluster-C PD is the primary outcome, assessed with clinical interviews by independent raters blind for treatment. Functioning and wellbeing are important secondary outcomes. Assessments take place at week 0 (baseline), 17 (mid-GST), 34 (post-GST), 51 (post-booster sessions of GST), and 2 years (FU). Patient characteristics predicting better response to a specific treatment are studied, e.g., childhood trauma, autistic features, and introversion. A tool supporting patients and clinicians in matching treatment to patient will be developed. An economic evaluation investigates the cost-effectiveness and cost-utility from a societal perspective. A process evaluation by qualitative methods explores experiences of participants, loved ones and therapists regarding recovery, quality of life, and improving treatment.
This study will determine the (cost-)effectiveness of treatments for Cluster-C PDs regarding treatment type as well as optimal matching of patient to treatment and deliver insight into which aspects help Cluster-C-PD patients recover and create a fulfilling life.
Dutch Trial Register: NL9209 . Registered on 28-01-2021.
鉴于临床人群中群集 C 型人格障碍（PD）的高患病率、疾病负担、高社会成本和共病障碍的预后不良，如果群集 C 型 PD 得到充分治疗，医疗保健可以取得重大进展。迄今为止发表的唯一一项对照成本效益研究发现，个体图式治疗（IST）优于常规治疗（TAU）。与 IST 相比，团体图式治疗（GST）可能会提高成本效益，因为可以在（>50%）更短的时间内治疗更多的患者。然而，迄今为止，尚无 RCT 支持其（成本）有效性。本研究的总体目标是评估 GST 治疗群集 C PD 的证据，并改善个体患者的治疗分配。主要解决三个问题：1）与 TAU 相比，GST 治疗群集 C PD 是否具有成本效益？2）与 IST 相比，GST 治疗群集 C PD 是否具有成本效益？3）哪些患者特征预示着对 GST、IST 或 TAU 的反应更好？
在一项多中心 RCT 中，在 10 个地点的 378 名群集 C PD 患者中比较 GST、IST 和 TAU 三种治疗条件。GST 和 IST 遵循治疗方案，并在 1 年内完成。TAU 是根据常规程序在该地点提供的最佳替代治疗。采用独立评估者进行临床访谈，以盲法评估群集 C PD 的严重程度，作为主要结局。功能和健康状况是重要的次要结局。评估在第 0 周（基线）、第 17 周（GST 中期）、第 34 周（GST 后）、第 51 周（GST 强化治疗后）和第 2 年（FU）进行。研究了预测患者对特定治疗反应更好的患者特征，例如儿童时期创伤、自闭症特征和内向。将开发一种支持患者和临床医生根据患者特征匹配治疗的工具。一项经济评估从社会角度探讨了治疗的成本效益和成本效用。通过定性方法进行的过程评估探讨了参与者、亲人以及治疗师对康复、生活质量和改善治疗的体验。
本研究将确定群集 C PD 治疗的（成本）效果，包括治疗类型以及患者与治疗的最佳匹配，并深入了解有助于群集 C-PD 患者康复和创造充实生活的各个方面。
荷兰试验注册处：NL9209。于 2021 年 1 月 28 日注册。
