Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock

摘要 这项研究，“生物行为干预，以减少创伤后应激障碍症状后，ICD休克，”解决了一个关键的 需要在心脏病护理描述的可行性和可接受性，及时，非常有前途， 为最近接受过ICD电击的患者提供电子干预。研究 干预和结果旨在减少焦虑，提高恢复日常生活活动（ADL）， 并防止严重的痛苦和创伤后应激障碍（PTSD）的发展， 提高生活质量。该研究是一项双臂、嵌入式混合方法、随机化试验（N=60，30/组）。 目的是确定自我管理干预（SPSM）的可行性和潜在影响， 常规治疗（UC）与单独UC相比，在ICD电击后的关键1个月期间提供， 痛苦是高的。将在ICD电击后1个月内进行干预; 6个月随访 将用于评估干预效果的可持续性，并确定PTSD的发病率是否 降低SPSM包括：1）心率（HR）自我监测的培训; 2）通过4 自定进度的网络模块。研究干预措施在关键时刻进行，即ICD之后 当压力很大时会休克，但PTSD尚未发展。具体目标是：1）检查 SPSM干预加UC与单独UC对1个月和6个月时ICD休克焦虑主要结局的影响 休克后事件，2）描述SPSM + UC与单独UC相比对次要结局的影响 每日总体力活动、抑郁、PTSD症状、QOL、唾液皮质醇水平和自我效能， 休克事件后1个月和6个月的结局预期，以及3）评估可行性、可接受性和安全性 的SPSM干预，SDOH将被用来描述不同的反应SPSM干预。这 这项研究填补了ICD患者护理方面的一个重大空白，通过对一种简短的、新颖的 提供提高生活质量的知识和技能的具有成本效益的干预措施。研究结果 将用于设计未来更大规模的RCT，以测试更多样化样本的干预有效性， 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.