Optimizing a self-directed mobile mindfulness intervention for improving

摘要新型冠状病毒（COVID-19）大流行迅速而彻底地改变了世界各地的医疗服务的获取和提供，因为越来越多的患者涌入诊所，医院病房和重症监护室（ICU）。患有类似疾病的患者有很高的持续性心理困扰症状，包括抑郁，焦虑和创伤后应激障碍。目前，在这个深深的恐惧和担忧、“社交距离”、取消诊所、隔离和检疫措施以及医院人手不足的时代，几乎没有容易获得的治疗方法。Lift是我们新颖的基于移动的应用程序的正念干预，可以解决COVID患者的痛苦和获得护理的问题。Lift在重症监护室（ICU）中成功试用，迄今为止对任何基于ICU的试验的症状影响最大（R34 AT 00819）。Lift目前正在进行一项多中心析因实验性临床试验，旨在确定8个版本中的哪一个版本在缓解症状、成本和可扩展性方面进行了优化（母公司U 01 AT 009974）。本补充文件旨在扩大母项目U 01的范围，以完成据我们所知从未尝试过的工作：测试在大流行期间迅速部署的自动心理困扰干预的临床影响。为了解决这一独特的临床差距，我们提出了一个为期一年的补充项目，涉及额外300名COVID-19心肺衰竭幸存者，具体目标有三个：（1）比较两种自动化、通过包括Lift在内的相同移动的应用程序平台交付的自主程序（高剂量/ App对症状的反应/工作人员的介绍电话）与经验证的教育对照，以及（2）按治疗组以及整个CORAL COVID队列比较COVID RCT患者的长期（6个月）结局，以及（3）探索大流行中干预部署、吸收和参与的障碍和促进因素。这项实用的随机临床试验将嵌套在NIH PETAL网络的CORAL COVID试验中。我们的补充方案的创新要素包括其范式转变的快速部署战略，不需要直接接触患者;自动化功能（电子同意，症状筛查，数据收集，针对症状变化的内容）;独特的人群和流行病环境;以及易于传播的移动的应用程序交付系统。PETAL网络的广泛覆盖范围及其站点的众多COVID阳性患者是测试干预措施的理想选择，该干预措施可以通过个性化但可广泛扩展的治疗来推进该领域。据我们所知，这将是第一个在大流行病中迅速部署的身心干预措施。因此，所吸取的经验教训可以帮助指导今后的干预措施，这些干预措施可以迅速扩大规模，以满足地方、区域或国家危机时期激增的需求。

Abstract The novel coronavirus (COVID-19) pandemic has changed access to and the delivery of medical care across the world rapidly and radically as increasingly large waves of patients fill clinics, hospital wards, and intensive care units (ICUs). Patients with comparable illnesses have high rates of persistent psychological distress symptoms including depression, anxiety, and PTSD. Currently there are few easily accessible therapies available for this distress in this time of deep fear and worry, ‘social distancing,’ cancelled clinics, isolation and quarantine practices, and understaffed hospitals. Lift, our novel mobile app-based mindfulness intervention, can address COVID patients’ distress and access to care issues. Lift was piloted successfully in the intensive care unit (ICU) and has shown the greatest impact on symptoms of any ICU-based trial conducted to date (R34 AT00819). Lift is currently in the midst of a multicenter factorial experimental clinical trial designed to determine which of 8 versions is optimized for symptom relief, cost, and scalability (parent U01 AT009974). This Supplement seeks to expand the scope of the parent U01 project to do what has never to our knowledge has been attempted: test the clinical impact of an automated psychological distress intervention rapidly deployed during a pandemic. To address this unique clinical gap, we propose a 1-year supplemental project involving an additional 300 cardiorespiratory failure survivors of COVID-19 with three specific aims: (1) Compare the clinical impact of two automated, self-directed programs delivered through an identical mobile app platform including Lift (High dose / App Response to Symptoms / Intro call by staff) vs. a validated education control and (2) Compare long-term (6-month) outcomes of COVID RCT patients both by treatment arm as well to the entire CORAL COVID cohort, and (3) Explore barriers and facilitators to intervention deployment, uptake, and engagement in a pandemic. This pragmatic randomized clinical trial will be nested within the NIH PETAL network’s CORAL COVID trials. Innovative elements of our supplement proposal include its paradigm-shifting rapid deployment strategy that requires no direct patient contact; automated features (electronic consent, symptom screening, data collection, content directed to change in symptoms); the unique population and pandemic setting; and easily disseminatable mobile app delivery system. The extensive reach of the PETAL network and its sites’ numerous COVID positive patients are ideal for testing an intervention that could advance the field with a personalized, yet broadly scalable therapy. To our knowledge, this would be the first mind-body intervention rapidly deployed in a pandemic. As such, the lessons learned could help to guide future interventions that can be quickly scaled to meet surge demands in times of local, regional, or national crisis.