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.

由于每年接受治疗的200万心肺衰竭患者的存活率有所提高， 美国重症监护病房(ICU)，研究已经澄清了这些幸存者是如何遭受严重和 心理困扰的持续性症状--抑郁、焦虑和创伤后应激障碍 (创伤后应激障碍)-出院后。然而，与患者经历相关的干预措施很少。 这也适应了他们在个性化护理方面的许多身体、社会和经济障碍。至 为了填补这一空白，我们开发了基于电话和网络的应对技能培训(CST)计划。 CST是一种有经验支持的心理社会干预，其目标是使用适应性应对 减少心理痛苦和提高生活质量的技能。我们进行了一个多中心 随机临床试验(RCT)，称为CSTEP，将CST与教育计划(EP)进行比较 ICU中因心肺衰竭而接受机械呼吸治疗的幸存者的总体样本。科委 在预先指定的亚组中，6个月后抑郁症状减少，生活质量提高 上升的基线遇险。该RCT还确定了有关Identi的最佳实践的关键问题- 为那些高度痛苦但身体疾病可控的患者命名，以及提供 以更方便、更可扩展的方式进行干预。在最近的一项RCT测试中，正念 干预(LIFT)，我们发现自我定向的移动应用方法增加了剂量、依从性和 留存。然而，许多患者报告说，他们对基于冥想的干预热情不高。 在第二个多中心RCT之前，需要的是将有希望的CST内容应用到Lift- 启发基于移动应用程序的交付系统，然后在目标患者群体中进行测试 反应的可能性高(即高基线心理困扰)。因此，我们建议两年 R34混合方法项目，涉及110名心肺衰竭幸存者。我们的具体目标是：(一) 优化自主移动应用程序(MCST)和自动出院后求救工具的可用性 筛选系统；(2)在试点3臂RCT中测试MCST与常规护理的两个有希望的迭代，3- 月度跟踪，以及(3)探索实施MCST的促进者和障碍，使用这些数据来 通知MCST应用程序的任何必要的最终修订。 我们的团队拥有经过验证的专业知识来进行R34，这既是必要的，也是足够的 告知下一步注重效率的多中心RCT，可通过可个性化的 然而，可扩展的疗法。创新包括MCST的自动筛查范式转换方法， 治疗和结果评估。总体而言，MCST可以显著改善获得心理社会的机会 治疗和加强任何基于医院或诊所的干预。最后，这款R34解决了当前 美国国立卫生研究院、国家医学科学院和专业协会概述了研究的优先事项。

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