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背景、设计和方法:一项双中心随机对照试验:两种退伍军人创伤后应激障碍治疗方法的比较效果。

Rationale, design, and methods of a two-site randomized controlled trial: Comparative effectiveness of two treatments for posttraumatic stress disorder in veterans.

机构信息

Providence Veterans Affairs Medical Center, Providence, RI, United States of America; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, United States of America.

Department of Psychiatry, Georgetown University Medical School, Washington, DC, United States of America.

出版信息

Contemp Clin Trials. 2021 Jun;105:106408. doi: 10.1016/j.cct.2021.106408. Epub 2021 Apr 17.

DOI:10.1016/j.cct.2021.106408
PMID:33872802
Abstract

PTSD is associated with serious problems in interpersonal functioning, including higher rates of marital conflict and divorce, disrupted relationships with family and friends, estrangement from others and social isolation. Cognitive behavioral and trauma focused treatments are effective for treating PTSD symptoms, but a substantial proportion of individuals, particularly veterans, with PTSD, do not engage, complete, or fully respond to these treatments, and the effects of these treatments on interpersonal functioning are unknown. There is a critical need for alternative treatments with established efficacy, and for treatments that directly address problems in relationship functioning. Interpersonal Psychotherapy for PTSD (IPT-PTSD) is a promising candidate for such a treatment. This paper describes the rationale, design, and methods of the first randomized controlled equivalence trial comparing IPT-PTSD with a first-line gold standard treatment for PTSD (Prolonged Exposure; PE) in the treatment of PTSD in veterans. Both treatments include up to 12 weekly individual sessions. Assessments were conducted at baseline, following sessions four and eight, end of treatment, and 3 and 6 months post-treatment. Primary hypotheses are that IPT-PTSD will be statistically equivalent to PE in reducing the severity of PTSD symptoms, and superior to PE in improving interpersonal functioning. Secondary hypotheses propose that IPT will be superior to PE in improving overall social adjustment and quality of life, and in reducing suicidal ideation. Findings from this study have the potential to improve treatment options for veterans struggling with PTSD and interpersonal problems.

摘要

创伤后应激障碍与人际关系功能严重问题有关,包括更高的婚姻冲突和离婚率、与家人和朋友关系破裂、与他人疏远和社会孤立。认知行为和创伤焦点治疗对治疗创伤后应激障碍症状有效,但相当一部分患有创伤后应激障碍的个体,特别是退伍军人,不参与、完成或完全对这些治疗作出反应,这些治疗对人际关系功能的影响也未知。迫切需要具有既定疗效的替代治疗方法,以及直接解决人际关系功能问题的治疗方法。创伤后应激障碍人际心理治疗(IPT-PTSD)是此类治疗的一个有前途的候选方法。本文介绍了一项首次随机对照等效试验的基本原理、设计和方法,该试验比较了 IPT-PTSD 与 PTSD 的一线黄金标准治疗(延长暴露;PE)在退伍军人创伤后应激障碍治疗中的疗效。两种治疗都包括最多 12 次每周的个体治疗。评估在基线、四次和八次治疗后、治疗结束时以及治疗后 3 个月和 6 个月进行。主要假设是 IPT-PTSD 在减轻 PTSD 症状严重程度方面与 PE 具有统计学等效性,并且在改善人际关系功能方面优于 PE。次要假设提出,IPT 将在改善整体社会适应和生活质量以及减少自杀意念方面优于 PE。这项研究的结果有可能改善与创伤后应激障碍和人际关系问题作斗争的退伍军人的治疗选择。

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