Design and methods of a randomized controlled trial evaluating the effects of the PE Coach mobile application on prolonged exposure among veterans with PTSD.
Design and methods of a randomized controlled trial evaluating the effects of the PE Coach mobile application on prolonged exposure among veterans with PTSD.
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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
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发表时间：
2023
影响因子：
2.2
通讯作者：
Zoellner,Lori
中科院分区：
文献类型：
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作者：
Reger,GregM;Smolenski,Derek;Williams,Rhonda;Norr,AaronM;Foa,Edna;Kuhn,Eric;Schnurr,PaulaP;Weathers,Frank;Zoellner,Lori
背景：人们对旨在支持患者通过循证心理治疗取得进展的移动应用程序的影响知之甚少。长期暴露（PE）是创伤后应激障碍（PTSD）的有效治疗方法，PE教练是一款治疗配套应用程序，可以增加患者对PE活性成分的参与，从而支持康复。方法：本文描述了一项随机临床试验，将评估在治疗后、治疗后1个月和4个月有和没有体育教练的体育锻炼。患有创伤后应激障碍的退伍军人（N= 124）将随机（1:1）根据先验定义的终止标准进行条件和完成多达15个疗程的治疗。我们假设，与没有体育教练的体育相比，有应用程序的体育会在ptsd相关的社会和职业功能（主要结果是ptsd相关功能量表）、生活质量方面有更大的改善，并在功能障碍、神经行为症状、抑郁和自杀意念方面有更大的减少（目的1）。我们还假设，根据DSM-5修订后的临床管理PTSD量表（目标2），与不使用该应用程序的PE相比，包括体育教练将降低被评估者掩盖的PTSD症状严重程度。我们假设体育教练将促进增加治疗依从性，通过完成体育作业来衡量（目标3）。我们将探讨体育教练对治疗参与的影响，通过减少治疗退出来衡量。结论体育教练的结果数据可以为传播工作提供信息，并有助于评估投资回报，指导未来心理健康应用程序的开发。临床试验注册号：clinicaltrials .gov NCT04959695
BackgroundLittle is known about the impact of mobile applications (apps) designed to support patients progressing through an evidence-based psychotherapy. Prolonged exposure (PE) is an efficacious treatment for posttraumatic stress disorder (PTSD) and PE Coach is a treatment companion app that may increase patient engagement with the active components of PE, thereby supporting recovery.MethodsThis paper describes a randomized clinical trial that will evaluate PE delivered with and without PE Coach at post-treatment, and 1-month and 4-months post-treatment. Veterans with PTSD (N= 124) will be randomized (1:1) to conditions and complete up to 15 treatment sessions based on a priori defined termination criteria. We hypothesize that compared to PE without PE Coach, PE with the app will result in greater improvements in PTSD-related social and occupational functioning (primary outcome is the PTSD-Related Functioning Inventory), quality of life, and greater reductions in functional impairment, neurobehavioral symptoms, depression, and suicidal ideation (Aim 1). We also hypothesize that including PE Coach will reduce assessor-masked PTSD symptom severity, relative to PE without the app, as assessed by the revised Clinician-Administered PTSD Scale for DSM-5 (Aim 2). We hypothesize that PE Coach will facilitate increased treatment adherence, as measured by completion of PE homework (Aim 3). We will explore the impact of PE Coach on treatment engagement, as measured by reduced treatment dropout.ConclusionData on the outcomes of PE Coach can inform dissemination efforts and help evaluate the return on investment to guide future mental health app development.Clinical trial registration numberClinicalTrials.gov NCT04959695