Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock

生物行为干预可减少 ICD 电击后的 PTSD 症状

基本信息

批准号：
10722157
负责人：
CYNTHIA M DOUGHERTY
金额：
$ 42.01万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-22 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10722157
关键词：
Activities of Daily Living Address Adherence Advocate American Anxiety Arrhythmia Cardiac Cardiology Cardiovascular system Caring Chronic stress Cognition Collection Consent Data Development Distress Effectiveness of Interventions Eligibility Determination Emergency department visit Event Exercise Feedback Future Health Health Status Heart Arrest Heart Rate Heart failure Home Hospitalization Household Hydrocortisone Implant Implantable Defibrillators Incidence Individual Informal Social Control Intervention Intervention Studies Knowledge Learning Life Measures Mental Depression Mental Health Mental Health Services Methods Monitor Nurses Online Systems Outcome Pain Patient Care Patient-Focused Outcomes Patients Personal Satisfaction Physical activity Physicians Physiological Population Post-Traumatic Stress Disorders Professional counselor Protocols documentation Psychologist Quality of life Randomized Recreation Rehabilitation therapy Research Research Personnel Risk Safety Salivary Sampling Self Assessment Self Efficacy Self Management Sex Behavior Shock Stress Symptoms Technology Testing Time Training Translating Ventricular Arrhythmia Vulnerable Populations Withdrawal acceptability and feasibility anxiety reduction arm biobehavior clinical care clinical practice cost cost effective intervention design disability disability risk emotional distress expectation experience follow-up heart rate monitor improved innovation intervention delivery intervention effect medication nonadherence mental health counseling mortality novel online intervention patient population prevent primary outcome prospective psychological distress randomized trial recruit response secondary outcome skills social cognitive theory social health determinants stem stress reduction stroke risk therapy design treatment as usual usability

项目摘要

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.

抽象的这项研究，“ ICD冲击后减少PTSD症状的生物行为干预措施”，解决了一个关键通过描述及时，有前途的可行性和可接受性，在心脏病学护理中的需求对于最近收到ICD付出的休克的患者的电子服务干预措施。研究干预和结果旨在减少动画，增强对日常生活活动的回报（ADL），并防止严重困扰和创伤后应激障碍（PTSD）的发展，并最终促进生活质量。该研究是两臂嵌入式混合方法，随机试验（n = 60，30/组）。目的是确定自我管理干预（SPSM）加的可行性和潜在影响与仅UC相比，通常的护理（UC）（UC），在ICD冲击后的关键1个月内交付困扰很高。 ICD冲击后1个月内将进行干预； 6个月的随访将用于评估干预效果的可持续性，并确定PTSD的事件是否为减少。 SPSM包括：1）心率训练（HR）自我监控； 2）通过4个个性化学习自节奏的基于网络的模块。研究干预措施是在ICD之后紧密的关键时间进行的压力很高时的休克，但PTSD尚未发展。具体目的是：1）检查 SPSM干预加UC与UC仅在1和6个月的ICD冲击动画的主要结果上震后事件，2）描述SPSM加UC的影响与单独使用UC对次要结果相比每日体育锻炼，抑郁症，PTSD症状，QOL，唾液皮质醇水平以及自我有效和震撼后1和6个月的结果期望，以及3）评估可行性，可接受性和安全性在SPSM干预中，SDOH将用于描述对SPSM干预的差异反应。这通过系统测试简短，新颖以及具有成本效益的干预措施，提供了改善生活质量的知识和技能。研究结果将用于设计未来较大的RCT，以测试更多潜水员样本和设置。