Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock

摘要 这项研究“减少 ICD 电击后 PTSD 症状的生物行为干预”解决了一个关键问题 通过描述及时的、高度有前途的、 对最近接受 ICD 电击的患者进行电子干预。该研究 干预和结果旨在减少焦虑、增强日常生活活动 (ADL) 的恢复、 并预防严重痛苦和创伤后应激障碍（PTSD）的发展，最终 提高生活质量。该研究是一项双臂、嵌入式混合方法、随机试验（N=60，每组 30 人）。 目的是确定自我管理干预 (SPSM) 加的可行性和潜在影响 常规护理 (UC) 与单独 UC 相比，在 ICD 电击后关键的 1 个月内进行 痛苦程度很高。干预措施将在 ICD 电击后 1 个月内实施； 6个月的随访 将用于评估干预效果的可持续性并确定 PTSD 的发生率是否 减少。 SPSM包括：1）心率（HR）自我监测培训； 2) 通过 4 进行个性化学习 自定进度、基于网络的模块。研究干预措施是在 ICD 紧随其后的关键时刻实施的 压力大时会感到震惊，但 PTSD 尚未发展。具体目标是： 1) 检验效果 SPSM 干预加 UC 与单独 UC 对 1 个月和 6 个月 ICD 休克焦虑主要结局的影响 休克后事件，2) 描述 SPSM 加 UC 与单独 UC 相比对次要结果的影响 每日总体力活动、抑郁、创伤后应激障碍 (PTSD) 症状、生活质量、唾液皮质醇水平和自我效能 休克事件后 1 个月和 6 个月的结果预期，以及 3) 评估可行性、可接受性和安全性 对于 SPSM 干预，SDOH 将用于描述对 SPSM 干预的不同反应。这个 该研究通过对简短、新颖的系统测试，填补了 ICD 患者护理方面的重大空白 具有成本效益的干预措施，提供提高生活质量的知识和技能。研究结果 将用于设计未来更大的随机对照试验，以测试更多样化样本的干预效果 设置。

ABSTRACT This study, “Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock,” addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe distress and post-traumatic stress disorder (PTSD), and ultimately promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial (N=60, 30/group). The purpose is to determine feasibility and potential effects of a self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered during the critical 1 month period after an ICD shock when distress is high. The intervention will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of PTSD is reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions are delivered at a crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed. The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to describe differential responses to the SPSM intervention. This study fills a significant gap in the care of patients with an ICD, through the systematic testing of a brief, novel and cost-effective intervention that provides the knowledge and skills to improve quality of life. Study findings will be used to design future larger RCTs to test intervention effectiveness for more diverse samples and settings.