Optimizing a self-directed mobile copying skills training intervention for improving cardiorespiratory failture survivors' psychological distress: a pilot randomized clinical trial

优化自我导向的移动复印技能训练干预以改善心肺衰竭幸存者的心理困扰：一项试点随机临床试验

• 批准号: 9906936
• 负责人: Christopher Ethan Cox
• 金额: $ 36.23万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-15 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9906936
• 关键词: Academy; Address; Adherence; Anxiety; Benchmarking; Clinic; Clinical Trials; Coping Skills; Data; Development; Distress; Dose; Education; Educational Intervention; Elements; Enrollment; Ensure; Environment; Failure; Frequencies; Goals; Health Services Accessibility; Home environment; Hospitals; Improve Access; Information Systems; Intensive Care Units; Intervention; Interview; Measures; Mechanical ventilation; Medicine; Meditation; Mental Depression; Methods; Online Systems; Outcome Assessment; Participant; Patients; Perception; Post-Traumatic Stress Disorders; Professional Organizations; Psychosocial Assessment and Care; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research; Research Design; Research Personnel; Research Priority; Sampling; Self-Direction; Severities; Specific qualifier value; Structure; Subgroup; Survivors; Symptoms; System; Telephone; Testing; Text; Training Programs; United States National Institutes of Health; Update; arm; barrier to care; base; depressive symptoms; design; experience; follow-up; improved; innovation; mindfulness; mindfulness intervention; mobile application; multidisciplinary; patient oriented; patient population; persistent symptom; personalized care; post-traumatic symptoms; programs; psychological distress; psychosocial; reduce symptoms; response; screening; skills training; social; success; therapy outcome; treatment as usual; usability

As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), research has clarified how these survivors suffer from severe and persistent symptoms of psychological distress—depression, anxiety, and post-traumatic stress disorder (PTSD)—after discharge. However, few interventions exist that are relevant to patients' experiences and that also accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, we developed a telephone- and web-based coping skills training (CST) program. CST is an empirically-supported psychosocial intervention that targets the use of the adaptive coping skills to decrease psychological distress and improve quality of life. We conducted a multicenter randomized clinical trial (RCT) called CSTEP that compared CST to an education program (EP) among a general sample of ICU survivors who received mechanical ventilation for cardiorespiratory failure. CST reduced depression symptoms and improved quality of life at 6 months in a pre-specified subgroup with elevated baseline distress. This RCT also identified key questions regarding best practices for identi- fying patients who are highly distressed yet whose physical illness is manageable, as well as delivering the intervention in a more convenient, and scalable manner. In a recent RCT testing a mindfulness intervention (LIFT), we found that a self-directed mobile app approach increased dose, adherence, and retention. However, many patients reported low enthusiasm for a meditation-based intervention. What is needed before a second multicenter RCT is to apply the promising CST content to a LIFT- inspired mobile app-based delivery system, and then to test it within a targeted patient population with a high likelihood of response (i.e., high baseline psychological distress). Therefore, we propose a 2-year R34 mixed-methods project involving 110 cardiorespiratory failure survivors. Our specific aims will: (1) Optimize the usability of a self-directed mobile app (mCST) and an automated post-discharge distress screening system; (2) Test two promising iterations of mCST vs. usual care in a pilot 3-arm RCT with 3- month follow up, and (3) Explore facilitators and barriers to mCST implementation, using these data to inform any necessary final revisions to the mCST app. Our team has the proven expertise to conduct this R34, which is both necessary and sufficient to inform a next-step efficacy-focused multicenter RCT that could advance the field with a personalizable yet scalable therapy. Innovations include mCST’s paradigm-shifting approach to automated screening, therapy, and outcomes assessment. Overall, mCST could significantly improve access to psychosocial therapies and augment any hospital- or clinic-based intervention. Last, this R34 addresses current research priorities outlined by the NIH, the National Academy of Medicine, and professional societies.

随着200万心脏呼吸衰竭的人的生存有所改善 美国重症监护病房（ICU），研究阐明了这些冲浪者如何遭受严重和 心理困扰的持续症状 - 抑郁，动画和创伤后应激障碍 （PTSD） - 出院后。但是，很少有与患者经验有关的干预措施 而且，这也接受了他们的许多身体，社会和财务障碍。到 填补这一空白，我们开发了一个基于电话和网络的应对技能培训（CST）计划。 CST是一种经验支持的社会心理干预措施，针对适应性应对的使用 减少心理困扰并改善生活质量的技能。我们进行了多中心 将CST与CST与教育计划（EP）进行比较的随机临床试验（RCT） ICU表面的一般样本，他们接受了心脏呼吸衰竭的机械通气。 CST 在预先指定的亚组中，抑郁症状减少和改善了生活质量 升高的基线遇险。该RCT还确定了有关识别最佳实践的关键问题 - 对高度痛苦但身体疾病易于控制的患者以及交付的患者 干预以更方便，可扩展的方式。在最近的RCT测试中 干预（提升），我们发现一种自我指导的移动应用方法增加了剂量，依从性和 保留。但是，许多患者报告对基于冥想的干预的热情低。 在第二个多中心RCT之前需要的是将承诺的CST内容应用于电梯 - 启发了基于移动应用程序的交付系统，然后在目标患者人群中进行测试 反应的可能性很大（即，基线高心理困扰）。因此，我们提出了2年 R34混合方法项目涉及110个心肺衰竭生存。我们的具体目标将：（1） 优化自我指导的移动应用程序（MCST）和自动化后的可用性 筛选系统； （2）测试MCST的两个承诺迭代与常规护理3臂RCT，3-- 一个月跟进，以及（3）探索促进者和MCST实施的障碍，使用这些数据来 通知MCST应用程序的任何必要的最终修订。 我们的团队具有行为的专业知识来进行此R34，这既需要又足够 告知下一步有效的多中心RCT，该RCT可以通过个性化提高该领域 可扩展的疗法。创新包括MCST的自动筛选范式移动方法， 治疗和结果评估。总体而言，MCST可以显着改善对心理心理的机会 治疗并增加基于医院或诊所的干预措施。最后，此R34解决当前 NIH，美国国家医学院和专业社会概述的研究优先事项。

项目成果

Feasibility of Mobile App-based Coping Skills Training for Cardiorespiratory Failure Survivors: The Blueprint Pilot Randomized Controlled Trial.

基于移动应用程序的心肺衰竭幸存者应对技能培训的可行性：蓝图试点随机对照试验。

• DOI: 10.1513/annalsats.202210-890oc
• 发表时间: 2023
• 期刊: Annals of the American Thoracic Society
• 影响因子: 8.3
• 作者: Cox,ChristopherE;Kelleher,SarahA;Parish,Alice;Olsen,MarenK;Bermejo,Santos;Dempsey,Katelyn;Jaggers,Jennie;Hough,CatherineL;Moss,Marc;Porter,LauraS
• 通讯作者: Porter,LauraS