Optimizing a self-directed mobile mindfulness intervention for improving

摘要随着越来越多的患者涌入诊所、医院病房和重症监护病房(ICU)，新型冠状病毒(新冠肺炎)大流行已经迅速和彻底地改变了世界各地获得和提供医疗服务的方式。患有类似疾病的患者有很高的持续性心理痛苦症状，包括抑郁、焦虑和创伤后应激障碍。目前，在这种极度恐惧和担忧、社会疏远、诊所被取消、隔离和隔离做法以及医院人手不足的时候，几乎没有容易获得的治疗方法来治疗这种痛苦。Lift是我们基于移动应用程序的新型正念干预，可以解决COVID患者的痛苦和获得护理的问题。Lift在重症监护病房(ICU)中成功试用，并在迄今进行的所有基于ICU的试验中显示出对症状的最大影响(R34 AT00819)。Lift目前正在进行一项多中心因素实验临床试验，旨在确定8个版本中的哪个版本在症状缓解、成本和可扩展性方面进行了优化(母公司U01 AT009974)。本补编旨在扩大母公司U01项目的范围，以做我们所知从未尝试过的事情：测试在大流行期间迅速部署的自动心理痛苦干预的临床影响。为了弥补这一独特的临床缺口，我们提出了一个为期一年的补充项目，涉及另外300名新冠肺炎患者的心肺衰竭幸存者，有三个具体目的：(1)比较两个通过相同移动应用程序平台交付的自动化、自主程序的临床影响，包括Lift(工作人员对症状的大剂量/应用程序反应)与有效的教育控制；(2)比较COVID随机对照试验患者通过治疗手段以及整个Coral CoVID队列进行干预的长期(6个月)结果，以及(3)探索在大流行中部署、吸收和参与干预措施的障碍和促进者。这项务实的随机临床试验将嵌套在NIH Petal网络的珊瑚COVID试验中。我们补充方案的创新元素包括：无需与患者直接接触的转变范式的快速部署策略；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)；独特的人口和流行病背景；以及易于传播的移动应用交付系统。Petal网络的广泛覆盖范围及其网站的众多COVID阳性患者是测试一种干预措施的理想选择，这种干预措施可以通过个性化但可广泛扩展的疗法来推动该领域的发展。据我们所知，这将是第一次在大流行中迅速部署的心身干预。因此，吸取的经验教训可以帮助指导未来的干预措施，这些干预措施可以迅速扩大规模，以满足地方、地区或国家危机时期的激增需求。

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.