This is a randomized clinical trial (RCT) nested within the NIH PETAL Network's COVID cohort study (BLUE CORAL [Biology and Longitudinal Epidemiology: COVID Observational Study]) of patients hospitalized for COVID-19-related illness. COVID-19 patients enrolled in BLUE CORAL with elevated distress symptoms 1 month post-discharge will be randomized to either the Lift mobile app intervention or a usual care control.
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, a novel mobile app-based mindfulness intervention, may be able to address COVID-19
patients' distress and access to care issues. Lift was piloted successfully in the intensive
care unit (ICU; R34 AT00819) and 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 2-arm, parallel group randomized clinical trial seeks to expand the scope of the parent
U01 project to test the clinical impact of a psychological distress intervention rapidly
deployed during a pandemic. This trial will include 300 patients who were hospitalized due to
COVID-19; collect data at 1, 3, and 6 months post-discharge; and address 3 specific aims: (1)
Compare the clinical impact of Lift vs. usual care control and (2) Compare long-term
(6-month) outcomes of RCT patients both by treatment arm as well to the entire BLUE CORAL
cohort, and (3) Explore participant-reported barriers and facilitators to intervention
deployment, uptake, and engagement in a pandemic.
Behavioral: Lift
The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
BLUE CORAL eligibility (the parent cohort study from which RCT participants will be
recruited)
Inclusion criteria:
1. Adult hospitalized within 14 days of a positive PCR test for COVID-19
2. Evidence of acute COVID-19, with fever or respiratory manifestations, as characterized
by signs and symptoms such as cough, dyspnea, tachypnea, hypoxemia, and infiltrates on
chest imaging.
Exclusion criteria:
1. Lack of informed consent
2. More than 72 hours of continuous hospitalization.
3. Comfort care orders in place at the time of enrollment and/or unexpected to survive
for 24 hours
4. Prisoners
5. Previous enrollment in BLUE CORAL
LIFT COVID RCT eligibility
Inclusion criteria:
1. Enrolled in BLUE CORAL
2. Survival to time of BLUE CORAL 1-month post-discharge interview
2. English-speaking 3. Domiciled with access to a working telephone and smartphone, tablet,
or computer with wifi or internet connection 4. Absence of severe dementia or cognitive
dysfunction either before hospitalization or at time of 1 month post-discharge interview
Exclusion criteria:
1. PHQ-9 <5 at time of interview 1 month post-discharge
2. Suicidal ideation at time of interview 1 month post-discharge
University of Colorado - Denver
Aurora, Colorado, United States
University of Michigan
Ann Arbor, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Oregon Health & Sciences University
Portland, Oregon, United States
Christopher E Cox, MD, Principal Investigator
Duke University