Behavioral Science Division, National Center for PTSD at VA Boston Healthcare System, Boston, Massachusetts.
Department of Psychiatry, Boston University School of Medicine, Boston, Massachusetts.
JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911.
Posttraumatic stress disorder (PTSD) occurs more commonly among military service members than among civilians; however, despite the availability of several evidence-based treatments, there is a need for more efficient evidence-based PTSD treatments to better address the needs of service members. Written exposure therapy is a brief PTSD intervention that consists of 5 sessions with no between-session assignments, has demonstrated efficacy, and is associated with low treatment dropout rates, but prior randomized clinical trials of this intervention have focused on civilian populations.
To investigate whether the brief intervention, written exposure therapy, is noninferior in the treatment of PTSD vs the more time-intensive cognitive processing therapy among service members diagnosed with PTSD.
DESIGN, SETTING, AND PARTICIPANTS: The study used a randomized, noninferiority design with a 1:1 randomization allocation. Recruitment for the study took place from August 2016 through October 2020. Participants were active-duty military service members diagnosed with posttraumatic stress disorder. The study was conducted in an outpatient setting for service members seeking PTSD treatment at military bases in San Antonio or Killeen, Texas.
Participants received either written exposure therapy, which consisted of 5 weekly sessions, or cognitive processing therapy, which consisted of 12 twice-weekly sessions.
Participants were assessed at baseline and at 10, 20, and 30 weeks after the first treatment session. The primary outcome measure was PTSD symptom severity assessed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Noninferiority was defined as the difference between the 2 groups being less than the upper bound of the 1-sided 95% CI-specified margin of 10 points on the CAPS-5.
Overall, 169 participants were included in the study. Participants were predominantly male (136 [80.5%]), serving in the Army (167 [98.8%]), with a mean (SD) age of 34 (8) years. Eighty-five participants were randomly assigned to written exposure therapy, with 65 (76.5%) completing all treatment sessions, and 84 to cognitive processing therapy, with 47 (54.8%) completing all treatment sessions. Findings indicated that written exposure therapy was noninferior to cognitive processing therapy, with the largest difference in change in outcome between the treatment conditions of 3.96 points on the outcome measure. The 1-sided 95% CI upper limit was less than 10 points across time points in both groups and ranged from 4.59 at week 30 to 6.81 at week 10. Within-condition effect sizes ranged from a Cohen d of 0.48 for the written exposure therapy group in the intention-to-treat analysis at week 10 to 0.95 for the cognitive processing therapy group in the per-protocol analysis at week 10, and between-condition effect size ranged from 0.06 in the intention-to-treat analysis at week 30 to 0.22 in the per-protocol analysis at week 10.
In this randomized clinical trial, support was found for an effective and more efficient PTSD treatment approach for service members. Future research should determine who does and does not benefit from PTSD treatment to best maximize treatment outcomes.
ClinicalTrials.gov Identifier: NCT03033602.
创伤后应激障碍（PTSD）在军人中比在平民中更为常见；然而，尽管有几种循证治疗方法，仍需要更有效的循证 PTSD 治疗方法，以更好地满足军人的需求。书面暴露疗法是一种简短的 PTSD 干预，由 5 次治疗组成，无治疗间隔作业，已证明有效，且与低治疗脱落率相关，但之前这项干预的随机临床试验均集中在平民人群。
调查在 PTSD 服务人员中，与时间更密集的认知加工疗法相比，简短干预、书面暴露疗法治疗 PTSD 是否不劣效。
设计、设置和参与者：该研究采用了随机、非劣效性设计，1:1 随机分配。该研究的招募时间为 2016 年 8 月至 2020 年 10 月。参与者为被诊断患有创伤后应激障碍的现役军人。该研究在为圣安东尼奥或基林的军事基地寻求 PTSD 治疗的服务人员的门诊环境中进行。
参与者接受书面暴露疗法，每周进行 5 次治疗，或认知加工疗法，每周进行 2 次治疗，共 12 次。
参与者在首次治疗后的第 10、20 和 30 周进行评估。主要结局指标为使用 DSM-5 临床医生管理 PTSD 量表（CAPS-5）评估的 PTSD 症状严重程度。非劣效性定义为两组之间的差异小于 CAPS-5 规定的 10 点单侧 95%CI 边界值，该边界值为 1 点。
共有 169 名参与者参与了该研究。参与者主要为男性（136 [80.5%]），在军队服役（167 [98.8%]），平均（SD）年龄为 34（8）岁。85 名参与者被随机分配到书面暴露疗法组，其中 65 名（76.5%）完成了所有治疗，84 名参与者被分配到认知加工疗法组，其中 47 名（54.8%）完成了所有治疗。研究结果表明，书面暴露疗法与认知加工疗法不劣效，治疗条件之间的最大差异为 3.96 分。两组各时间点的单侧 95%CI 上限均小于 10 分，范围从第 30 周的 4.59 到第 10 周的 6.81。意向治疗分析中，书面暴露疗法组在第 10 周的效应量范围为 0.48，而在第 10 周的方案分析中，认知加工疗法组的效应量范围为 0.95；在第 30 周的意向治疗分析中，组间效应量范围为 0.06，而在第 10 周的方案分析中，组间效应量范围为 0.22。
在这项随机临床试验中，为军人提供了一种有效的、更有效的 PTSD 治疗方法。未来的研究应确定谁从 PTSD 治疗中受益，谁没有受益，以最大限度地提高治疗效果。
ClinicalTrials.gov 标识符：NCT03033602。
