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退伍军人事务部合作研究 #591 的设计:CERV-PTSD,创伤后应激障碍退伍军人的比较效果研究。

Design of VA Cooperative Study #591: CERV-PTSD, comparative effectiveness research in veterans with PTSD.

作者信息

Schnurr Paula P, Chard Kathleen M, Ruzek Josef I, Chow Bruce K, Shih Mei-Chiung, Resick Patricia A, Foa Edna B, Marx Brian P, Huang Grant D, Lu Ying

机构信息

National Center for PTSD (Executive Division), White River Junction, VT and Geisel School of Medicine at Dartmouth, Hanover, NH, USA.

Cincinnati VA Medical Center and University of Cincinnati, Cincinnati, OH, USA.

出版信息

Contemp Clin Trials. 2015 Mar;41:75-84. doi: 10.1016/j.cct.2014.11.017. Epub 2014 Nov 29.

DOI:10.1016/j.cct.2014.11.017
PMID:25457792
Abstract

CERV-PTSD is a randomized controlled trial of two of the most effective treatments for PTSD, Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT). Despite solid evidence that both treatments are effective, there is limited evidence about their effectiveness relative to one another. The primary objective is to compare the effectiveness of PE and CPT for reducing PTSD symptom severity in a healthcare system that offers both treatments. The secondary objective is to compare the effectiveness of PE and CPT for reducing the severity of comorbid mental health problems and service utilization as well as improving functioning and quality of life. The tertiary objective is to examine whether discrepancy between patient preferences and treatment assignment reduces the effectiveness of each treatment. Exploratory analyses will examine whether demographic and clinical characteristics predict differential response to PE and CPT. The study is designed to randomize 900 male and female veterans with PTSD due to any traumatic military event to receive PE or CPT. The standard dose of treatment is 12 weekly sessions but veterans who improve more rapidly may finish in fewer sessions and veterans who improve more slowly may have additional sessions. The primary outcome is improvement in PTSD symptoms, measured during and after treatment and then 3 and 6 months later. As a large multi-site trial with men and women, CERV-PTSD is designed to advance the delivery of care for PTSD by providing conclusive information about whether one treatment is better than the other, overall, and for different types of patients.

摘要

CERV-PTSD是一项针对创伤后应激障碍(PTSD)两种最有效治疗方法——延长暴露疗法(PE)和认知加工疗法(CPT)的随机对照试验。尽管有确凿证据表明这两种疗法都有效,但关于它们彼此相对有效性的证据有限。主要目标是在同时提供这两种疗法的医疗系统中,比较PE和CPT在减轻PTSD症状严重程度方面的有效性。次要目标是比较PE和CPT在减轻共病心理健康问题的严重程度、服务利用情况以及改善功能和生活质量方面的有效性。 tertiary目标是研究患者偏好与治疗分配之间的差异是否会降低每种治疗的有效性。探索性分析将研究人口统计学和临床特征是否能预测对PE和CPT的不同反应。该研究旨在将900名因任何创伤性军事事件而患有PTSD的男性和女性退伍军人随机分配接受PE或CPT治疗。标准治疗剂量为每周12次,但改善较快的退伍军人可能会在较少的疗程内完成治疗,而改善较慢的退伍军人可能需要额外的疗程。主要结果是PTSD症状的改善,在治疗期间和治疗后以及3个月和6个月后进行测量。作为一项涉及男性和女性的大型多中心试验,CERV-PTSD旨在通过提供关于一种治疗方法总体上是否优于另一种治疗方法以及对不同类型患者是否更优的确凿信息,推进PTSD的护理服务。

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