Optimizing a self-directed mobile mindfulness intervention for improving

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.