CompletedNot Applicable

Lift Mobile Mindfulness for COVID-19 Distress Symptoms

United States56 participantsStarted 2021-01-25

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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
✕. Enrolled in BLUE CORAL
✕. Survival to time of BLUE CORAL 1-month post-discharge interview
✕. PHQ-9 \<5 at time of interview 1 month post-discharge

What they're measuring

Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge

Timeframe: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)

Trial details

NCT IDNCT04581200

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-30

Results submitted2023-03-21

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