Lift Mobile Mindfulness for COVID-19 Distress Symptoms

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2022-05-30

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.

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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.

Conditions

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COVID-19 Cardiorespiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Outcomes assessor will be blinded to group assignment, as will the investigators

Study Groups

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Lift mobile mindfulness program

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.

Group Type EXPERIMENTAL

Lift

Intervention Type BEHAVIORAL

The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.

Usual care control

Usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lift

The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

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. 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

1. PHQ-9 \<5 at time of interview 1 month post-discharge
2. Suicidal ideation at time of interview 1 month post-discharge

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No