Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock

摘要 这项名为“ICD休克后减少创伤后应激障碍症状的生物行为干预”的研究解决了一个关键问题 通过描述一种及时的、非常有希望的、 对最近接受ICD电击的患者进行电子干预。这项研究 干预和结果旨在减少焦虑，增强日常生活活动(ADL)的恢复， 并防止严重痛苦和创伤后应激障碍的发展，并最终 提升生活质量。本研究为双臂嵌入性混合随机试验(N=60，30例/组)。 目的是确定自我管理干预(SPSM)+的可行性和潜在影响 通常护理(UC)与单独UC相比，在ICD休克后的关键1个月期间提供 苦恼程度很高。介入治疗将在ICD休克后1个月内进行；6个月的随访 将用于评估干预效果的可持续性，并确定创伤后应激障碍的发生率是否 减少了。SPSM包括：1)心率(HR)自我监测培训；2)通过4)个性化学习 自定进度、基于Web的模块。研究干预措施是在ICD之后的关键时刻进行的 当压力很大时会感到震惊，但创伤后应激障碍尚未发展。具体目标是：1)检查以下方面的影响 SPSM干预加UC与单独UC对ICD休克焦虑患者1个月和6个月主要结局的影响 休克后事件，2)描述与单独使用UC相比，SPSM加UC对次要结果的影响 每天总的体力活动、抑郁、创伤后应激障碍症状、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 在SPSM干预中，SDOH将被用来描述对SPSM干预的差异反应。这 通过一项简短、新颖的系统测试，这项研究填补了ICD患者护理方面的一个重大空白 以及成本效益高的干预措施，提供提高生活质量的知识和技能。研究结果 将被用来设计未来更大的随机对照试验，以测试对更多样化的样本和 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.