Evaluation of Web-Based CBT for Women Veterans with PTSD

描述（由申请人提供）： 曾在军队服役的女性是美国人口中快速增长的少数群体，也是退伍军人事务部（VA）新用户增长最快的群体。最近的研究表明，与平民相比，女性退伍军人报告的创伤暴露率显着较高，因此创伤后应激障碍的发病率较高。尽管存在基于证据的创伤后应激障碍治疗，大多数女性退伍军人未充分利用VA护理。在提供治疗方面有一项创新，有可能接触到这些妇女并使她们参与进来，那就是利用互联网进行治疗。一些基于网络的CBT干预PTSD已经开发和评估。然而，除了一项评估外，所有这些评估都是在美国境外进行的，并且是针对平民的。例外情况是，“在压力情况下进行自我训练和教育”（DESTRESSS）主要在男性服役人员和退伍军人中进行测试;只有少数妇女参加了评估其疗效的两项临床试验。因此，关于其对这一人群的疗效的数据有限，这表明需要评估其是否能满足女性退伍军人的需求。此外，DESTRESS可能不是最适合女性的，因为它不是针对女性退伍军人独特的创伤经历和需求而设计的。例如，DESTRESS不包括关于人际创伤的心理教育，也不涉及对女退伍军人至关重要的社会支持和关系问题。为此，我们建议与女性退伍军人和临床医生进行定性研究，以获得他们对DESTRESS的反馈，根据这些反馈对该计划进行修改，然后进行一项试点随机临床试验（RCT），评估修订后的基于网络的电话辅助干预，仅提供电话支持。具体来说，在第一阶段，我们将与20名患有PTSD的女性退伍军人以及4-6名专家提供者进行半结构化访谈，了解他们对抑郁症的印象。由于这项形成性工作，将对“减压”方案进行修改，并将重新采访同样的女退伍军人和专家提供者，以提供对所作修改的反馈。在第二阶段，我们将进行一项试点随机对照试验，其中70名患有创伤后应激障碍的女性退伍军人被随机分配到干预或电话支持。将在基线、治疗后以及12周和24周随访评估时收集PTSD症状严重程度（主要结局）和抑郁和生活质量（次要结局）的测量结果。还将收集有关项目利用率、脱落率、患者满意度和可接受性的信息。这项研究的长期目标是为患有PTSD的女性退伍军人开发低成本，可获得的干预措施。研究结果应该改善我们对女性退伍军人的反应和偏好的一般知识，为他们量身定制的治疗护理，以及导致一个创新的，基于网络的干预与创伤后应激障碍的女性退伍军人。

DESCRIPTION (provided by applicant): Women who have served in the military are a rapidly growing minority in the US population and the fastest growing group of new users in the Department of Veterans Affairs (VA). Recent studies suggest that compared to civilians, women Veterans report significantly higher rates of trauma exposure and consequent high rates of PTSD. Despite the existence of evidence-based treatments for PTSD, most women Veterans underutilize VA care. One innovation in treatment delivery that has the potential to reach and engage these women is use of the Internet to administer treatment. A few web-based CBT interventions for PTSD have been developed and evaluated. However, all but one of these evaluations was conducted outside of the US and with civilian populations. The exception, "Delivery of Self Training and Education for Stressful Situations" (DESTRESSS), has been primarily tested on male service members and Veterans; only a handful of women participated in the two clinical trials evaluating its efficacy. Thus, ther are limited data on its efficacy for this population, suggesting the need to evaluate whether it wil meet the needs of women Veterans. Moreover, DESTRESS may not be optimal for women as it was not designed to target women Veterans' unique trauma experiences and needs. For example, DESTRESS does not include psychoeducation on interpersonal traumas nor does it address social support and relationship concerns central to women Veterans. To this end, we propose to conduct qualitative research with women Veterans and clinicians with content expertise to elicit their feedback on DESTRESS, make modifications to the program based on this feedback, and then conduct a pilot randomized clinical trial (RCT) evaluating the revised web-based, phone-assisted intervention with phone support only. Specifically, in Phase I we will conduct semi-structured interviews with 20 women Veterans with PTSD as well as with 4-6 expert providers regarding their impressions of DESTRESS. Changes will be made to DESTRESS as a result of this formative work, and the same women Veterans and expert providers will be re-interviewed to provide feedback on the changes made. In Phase II, we will conduct a pilot RCT wherein 70 women Veterans with PTSD are randomized to the intervention or phone support only. Measures of PTSD symptom severity (primary outcome) and depression and quality of life (secondary outcomes) will be collected at baseline, post-treatment, and 12- and 24-week follow-up assessments. Information about program utilization, dropout, patient satisfaction, and acceptability will also be collected. The long-term objective of this line of research is to develop low cost, accessible interventions for women Veterans with PTSD. Findings should improve our general knowledge about women Veterans' responses and preferences for care regarding tailored treatments for them, as well as result in an innovative, web-based intervention for women Veterans with PTSD.