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

在患有 PTSD 的退伍军人中进行长期暴露 (PE) 与带体育教练的 PE 的随机试验

• 批准号: 10701748
• 负责人: Greg Reger
• 金额: --
• 依托单位: VA PUGET SOUND HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-10-01 至 2026-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10701748
• 关键词: Address; Adherence; Aftercare; Anxiety; Caring; Clinic; Clinical; Code; Cognition; Cognitive; Companions; Comparative Study; DSM-V; Decision Making; Development; Devices; Diagnosis; Dissemination and Implementation; Doctor of Philosophy; Dropout; Drops; Effectiveness; Emotional; Equipment and supply inventories; Evidence based treatment; Feeling suicidal; Health Technology; Individual; Investments; Letters; Life; Manuals; Measures; Memory; Mental Depression; Mental Health; Military Personnel; Mobile Health Application; Monitor; Neurobehavioral Manifestations; Occupational; Outcome; Outcome Assessment; Outcome Measure; Participant; Patient Participation; Patient Self-Report; Patients; Post-Traumatic Stress Disorders; Problem Sets; Problem Solving; Provider; Psychotherapy; Publishing; Quality of life; Randomized; Randomized Controlled Clinical Trials; Recovery; Reporting; Research; Risk; Severities; Symptoms; Testing; Training; Trauma; Treatment Protocols; Treatment outcome; United States Department of Veterans Affairs; Update; Veterans; Work; blind; clinically relevant; comorbidity; comparative efficacy; connected care; design; digital; efficacy evaluation; efficacy research; efficacy testing; evidence base; executive function; functional disability; functional improvement; functional outcomes; habituation; improved; in vivo; innovation; mHealth; mobile application; neurobehavioral; post-traumatic stress; primary outcome; programs; prospective memory; randomized trial; routine care; social; software development; symptomatic improvement; therapy design; tool; treatment adherence; verbal

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

退伍军人面临创伤后应激障碍（PTSD）的风险，对社会和 占据生活和生活质量。长时间暴露（PE）是一种基于证据的心理治疗 有效治疗退伍军人的PTSD。但是，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的标准或没有临床意义 改变。具有PTSD的绝大多数退伍军人报告神经行为认知症状，可能是 考虑到执行功能和预期记忆的问题与PTSD有关 治疗辍学和较差的治疗结果。 [功能和症状变化的机制 PE包括在暴露期间的情绪激活，会议间习惯以及与PTSD相关的变化 负认知。这些机制通过口头叙述和处理创伤记忆出现 （想象中的曝光）并在日常生活中接近动画的情况（体内暴露） 通过日常作业练习实现。]增加的家庭作业依从性预测改善了PTSD症状 和功能。为了支持参加PE的患者，DOD/VA开发了移动应用程序（APP） “体育教练”。 PE教练的特征旨在增强患者遵守作业的能力 对恢复至关重要。体育教练可以提供退伍军人与PTSD的认知和组织支持 需要成功完成治疗并最大化结果。但是，关于 大多数心理健康技术增强的有效性，PE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 该应用程序的更新版本，没有研究评估PE教练对临床相关治疗的影响 结果。这项研究将进行一项随机，对照临床试验，以确定PE教练的效率 及其对与PTSD相关的社会和职业功能，PTSD症状以及作业的影响 依从性和辍学。该项目将与PTSD随机将[124]退伍军人与PE +PE Coach或 通常的PE（没有PE教练）。 [在这两种情况下的参与者都将分配相同的作业活动， 但是那些拥有PE + PE教练的人将通过PE Coach应用获得所有作业活动，而 那些通常的PE中的人将通过单独的标准工作簿讲义和数字音频获得作业 录制设备。 定义的终止标准并与已发布的治疗手册保持一致。结果 评估将在基线，治疗中途进行，治疗后以及1个月和4个月进行。 后续行动。主要结局指标将是创伤后应力相关的功能清单 （PRFI）。 PTSD症状将使用金标准临床医生管理PTSD量表进行评估 DSM-5，将由盲目治疗条件的独立评估者进行。功能，质量 在整个治疗过程中，每一个pe section将监测生活，自我报告的PTSD和抑郁症。一个 外部体育专家将编码15％的体育课程，以监测心理治疗的保真度 协议和作业依从性将在每个会议上报告，以测试PE教练对 坚持。弗吉尼亚州一直是心理健康移动应用程序开发的领导者，必须回应呼吁 研究这些应用程序是否有效，如果是，如何？这项研究通过测试效率来解决需求 PE Coach是PTSD研究最有效，有效的心理治疗之一的治疗伴侣 以及整个VA心理健康诊所中广泛传播的治疗方法。结果可以提供帮助 告知VA是否应该投资系统的实施和将PE教练传播为常规 弗吉尼亚州体育培训的一部分。 1

项目成果

Design and methods of a randomized controlled trial evaluating the effects of the PE Coach mobile application on prolonged exposure among veterans with PTSD.

一项随机对照试验的设计和方法，评估 PE Coach 移动应用程序对患有 PTSD 的退伍军人长期暴露的影响。

• DOI: 10.1016/j.cct.2023.107115
• 发表时间: 2023
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Reger,GregM;Smolenski,Derek;Williams,Rhonda;Norr,AaronM;Foa,Edna;Kuhn,Eric;Schnurr,PaulaP;Weathers,Frank;Zoellner,Lori
• 通讯作者: Zoellner,Lori