Randomized Trial of Prolonged Exposure (PE) vs. PE with PE Coach Among Veterans with PTSD

退伍军人患创伤后应激障碍(PTSD)的风险增加，这对社会和 职业功能和生活质量。长期暴露(PE)是一种以证据为基础的心理疗法 对退伍军人有效的创伤后应激障碍。然而，许多退伍军人退出心理治疗是为了 创伤后应激障碍和许多完成体育锻炼的人仍然符合创伤后应激障碍的标准，或者没有达到临床意义 变化。绝大多数患有创伤后应激障碍的退伍军人报告有神经行为认知症状，并可能 鉴于执行功能和前瞻记忆问题与创伤后应激障碍有关，特别危险 治疗退出和较差的治疗结果。的作用机制和症状变化 PE包括暴露期间的情绪激活、会话间的习惯化以及与创伤后应激障碍相关的变化 消极认知。这些机制通过口头叙述和处理创伤记忆而发生 (想象暴露)和在日常生活中引起焦虑的情况(活体暴露)，以及 通过每天的作业练习来实现。]作业依从性增加预示着创伤后应激障碍症状的改善 并发挥作用。为了支持患者参与PE，国防部/退伍军人事务部开发了移动应用程序(APP) “体育教练”。体育教练的特点是提高患者坚持作业的能力 对恢复至关重要。体育教练可以为患有创伤后应激障碍的退伍军人提供认知和组织支持 需要成功完成治疗并最大限度地提高结果。然而，人们对此知之甚少 大多数心理健康技术增强的有效性，这对体育教练也是如此。虽然 该应用程序用于常规退伍军人管理局护理，退伍军人管理局最近投资于 APP更新版，没有研究评估体育教练对临床相关治疗的影响 结果。本研究将进行随机对照临床试验，以确定体育教练的疗效 以及它对创伤后应激障碍相关的社会和职业功能、创伤后应激障碍症状和家庭作业的影响 坚持和退学。该项目将把[124]名患有创伤后应激障碍的退伍军人随机分配到PE+PE教练或 普通体育课(没有体育教练)。[两种条件下的参与者将被分配相同的家庭作业活动， 但那些拥有PE+PE Coach的人将通过PE Coach应用程序收到他们所有的家庭作业活动，而 那些平时上体育课的学生将通过单独的标准练习册和数字音频来收到作业 记录设备。]退伍军人将参加每周8-15次的个人体育心理治疗，基于 定义了终止标准，并与已公布的治疗手册一致。结果 评估将在基线、治疗中途、治疗后以及1个月和4个月进行 后续行动。主要结果衡量标准将是创伤后应激相关功能清单 (PRFI)。创伤后应激障碍症状将使用黄金标准的临床医生实施的创伤后应激障碍量表进行评估 DSM-5，这将由独立评估人员进行，对治疗情况视而不见。功能、质量 生活、自我报告的创伤后应激障碍和抑郁症将在整个治疗过程中每隔一段时间进行监测。一个 外部体育专家将对15%的体育课程进行编码，以监测心理治疗对治疗的忠诚度 礼仪和家庭作业遵守情况将在每节课上报告，以测试体育教练对 坚持不懈。退伍军人管理局一直是心理健康移动应用程序开发的领导者，必须响应 研究这些应用程序是否有效，如果有效，又是如何工作的？这项研究通过测试疗效来满足这一需求 体育教练是PTSD研究最多、最有效的心理疗法之一的治疗伙伴， 以及一种已在退伍军人管理局心理健康诊所广泛传播的治疗方法。结果可能会有所帮助 告知退伍军人管理局是否应该投资于系统地实施和推广体育教练 退伍军人事务部体育训练的一部分。 1

Veterans are at increased risk of posttraumatic stress disorder (PTSD), which negatively impacts social and occupational functioning and quality of life. Prolonged exposure (PE) is an evidence-based psychotherapy for PTSD that is effective in the treatment of Veterans. However, many Veterans drop out of psychotherapy for PTSD and many of those who complete PE still meet criteria for PTSD or do not achieve clinically meaningful change. The vast majority of Veterans with PTSD report neurobehavioral cognitive symptoms and may be at particular risk given that problems with executive functioning and prospective memory are related to PTSD treatment drop out and poorer treatment outcomes. [The mechanisms of functioning and symptom change in PE include emotional activation during exposure, between-session habituation, and changes in PTSD-related negative cognitions. These mechanisms occur via verbally recounting and processing trauma memories (imaginal exposure) and approaching anxiety provoking situations in day-to-day life (in vivo exposure) and are achieved by daily homework exercises.] Increased homework adherence predicts improved PTSD symptoms and functioning. To support patients participating in PE, the DoD/VA developed the mobile application (app) ‘PE Coach’. The features of PE Coach were designed to enhance patients’ ability to adhere with the homework critical to recovery. PE Coach may provide the cognitive and organizational support that Veterans with PTSD need to successfully complete treatment and maximize outcomes. However, little is known about the effectiveness of most mental health technology augmentations and this is true of PE Coach as well. Although the app is used in routine VA care and the VA recently invested in the software development required for an updated version of the app, no study has evaluated the impact of PE Coach on clinically relevant treatment outcomes. This study will conduct a randomized, controlled clinical trial to determine the efficacy of PE Coach and its impact on PTSD-related social and occupational functioning, PTSD symptoms, and homework adherence and dropout. The project will randomize [124] Veterans with PTSD to either PE +PE Coach or Usual PE (without PE Coach). [Participants in both conditions will have identical homework activities assigned, but those with PE + PE Coach will receive all of their homework activities through the PE Coach app, while those in Usual PE will receive their homework through separate, standard workbook handouts and digital audio recording device.] Veterans will participate in 8-15 weekly individual PE psychotherapy sessions, based on defined termination criteria and delivered consistent with the published treatment manual. Outcome assessments will be conducted at baseline, half-way through treatment, post-treatment, and at 1- and 4- month follow-ups. The primary outcome measure will be the Posttraumatic Stress Related Functioning Inventory (PRFI). PTSD symptoms will be assessed using the gold-standard Clinician Administered PTSD Scale for DSM-5, which will be conducted by independent assessors blind to treatment condition. Functioning, quality of life, self-reported PTSD, and depression will be monitored every-other PE session, throughout treatment. An external PE expert will code 15% of PE sessions to monitor the fidelity of psychotherapy to the treatment protocol, and homework adherence will be reported at each session to test the impact of PE Coach on adherence. VA has been a leader in mental health mobile app development and must respond to the call for research on whether these apps work, and if so, how? This study addresses that need by testing the efficacy of PE Coach, a treatment companion to one of the most researched, efficacious psychotherapies for PTSD, and a treatment that has been broadly disseminated throughout VA mental health clinics. Results can help inform whether VA should invest in systematic implementation and dissemination of PE Coach as a routine part of PE training in VA. 1