Lift Mobile Mindfulness for COVID-19 Distress Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Addressing Psychological Distress Symptoms Among Serious Illness Survivors of a Viral Pandemic With a Completely Self-directed, Symptom-responsive Mobile Mindfulness Intervention: a Randomized Controlled Trial

Conditions
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COVID-19, Cardiorespiratory Failure

Intervention / Treatment
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* Behavioral: Lift


Participation Criteria
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Eligibility Criteria
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BLUE CORAL eligibility (the parent cohort study from which RCT participants will be recruited) Inclusion criteria: Adult hospitalized within 14 days of a positive PCR test for COVID-19 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: Lack of informed consent More than 72 hours of continuous hospitalization. Comfort care orders in place at the time of enrollment and/or unexpected to survive for 24 hours Prisoners Previous enrollment in BLUE CORAL LIFT COVID RCT eligibility Inclusion criteria: Enrolled in BLUE CORAL 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: PHQ-9 <5 at time of interview 1 month post-discharge Suicidal ideation at time of interview 1 month post-discharge

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lift mobile mindfulness program<br>Will receive standard dose Lift mobile mindfulness program intervention content, app-based response to elevated symptoms, and no introductory call from a therapist. This program lasts 1 month and includes 4 unique weeks' worth of audio, video, and text content. | Behavioral: Lift<br>* The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.<br>|
| No Intervention: Usual care control<br>Usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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). | 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). | 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). | 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). | 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 | 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 | T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical illness, psychological distress, depression, anxiety, adults