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，这对社会和经济产生了负面影响。 职业功能和生活质量。延长暴露（PE）是一种循证心理治疗， 创伤后应激障碍是有效的治疗退伍军人。然而，许多退伍军人退出心理治疗， PTSD和许多完成PE的人仍然符合PTSD的标准或没有达到临床意义 变化绝大多数患有创伤后应激障碍的退伍军人报告神经行为认知症状， 鉴于执行功能和前瞻性记忆的问题与创伤后应激障碍有关， 治疗脱落和较差的治疗结果。[The功能和症状变化的机制， PE包括暴露期间的情绪激活，会话之间的习惯化，以及PTSD相关的变化。 消极的认知。这些机制通过口头叙述和处理创伤记忆发生 （想象中的暴露）和日常生活中引发焦虑的情况（体内暴露），并且是 通过每天的家庭作业练习。家庭作业坚持性增加预测PTSD症状改善 和功能。为了支持患者参与PE，DoD/VA开发了移动的应用程序（app） 体育教练体育教练的特点是提高病人坚持作业的能力 对恢复至关重要。体育教练可以提供认知和组织支持，退伍军人与创伤后应激障碍 需要成功完成治疗并最大化结果。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，体育教练也是如此。虽然 该应用程序用于常规VA护理，VA最近投资于所需的软件开发， 更新版本的应用程序，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 及其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 坚持和辍学。该项目将[124]患有创伤后应激障碍的退伍军人随机分为PE + PE教练或 体育教练（没有体育教练）。[两种情况下的参与者都将有相同的家庭作业， 但那些拥有PE + PE教练的人将通过PE教练应用程序接收所有的家庭作业活动， 那些在体育课上的学生将通过单独的标准练习册讲义和数字音频接收他们的家庭作业。 记录装置]。退伍军人将参加8 - 15周的个人体育心理治疗会议，根据 定义了终止标准，并按照已发布的治疗手册提供。结果 将在基线、治疗中途、治疗后以及1个月和4个月时进行评估 后续行动。主要的结果测量将是创伤后应激相关功能量表 （PRFI）。将使用金标准临床医生管理PTSD量表评估PTSD症状， DSM-5，将由对治疗条件不知情的独立评估者进行。功能、质量 在整个治疗过程中，每隔一次PE疗程将监测生活、自我报告的PTSD和抑郁。一个 外部PE专家将对15%的PE疗程进行编码，以监测心理治疗对治疗的忠诚度 方案，并在每次会议上报告家庭作业的遵守情况，以测试体育教练对 坚持。VA一直是心理健康移动的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，如何工作？本研究通过测试 体育教练，一个治疗伴侣的一个最研究，有效的心理疗法创伤后应激障碍， 以及一种在退伍军人事务部精神健康诊所广泛传播的治疗方法。结果可以帮助 告知VA是否应该投资于系统实施和传播体育教练作为常规 在VA的体育训练的一部分。 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