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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
56
The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
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
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge
Depression symptoms. Scores range from 0 (better) to 27 (worse)
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 6 Months Post-discharge
Depression symptoms. Scores range from 0 (better) to 27 (worse)
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 3 Months Post-discharge
Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 6 Months Post-discharge
Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Change in EuroQOL-5DL (Quality of Life) Scale at 3 Months Post-discharge
EuroQOL-5DL health states can be represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region. An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. The index is calculated by deducting the appropriate weights from 1, the value for full health. A higher index value indicates a greater health state; an increase in index value indicates an improvement in health state. The summary item can range from 0 (worst quality of life) to 100 (best quality of life).
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Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)
Change in EuroQOL-5DL (Quality of Life) Scale at 6 Months Post-discharge
EuroQOL-5DL health states can be represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region. An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. The index is calculated by deducting the appropriate weights from 1, the value for full health. A higher index value indicates a greater health state; an increase in index value indicates an improvement in health state. The summary item can range from 0 (worst quality of life) to 100 (best quality of life).
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge
Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)
Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge
Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use
Time frame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)