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Completed

NCT Number: NCT04581200

Lift Mobile Mindfulness for COVID-19 Distress Symptoms

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado - Denver, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Lift

Behavioral

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

Primary outcomes

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

    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)

    Depression symptoms. Scores range from 0 (better) to 27 (worse)

Secondary outcomes

  1. Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 6 Months Post-discharge

    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)

    Depression symptoms. Scores range from 0 (better) to 27 (worse)

  2. Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 3 Months Post-discharge

    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)

    Anxiety symptoms. Scores range from 0 (better) to 21 (worse).

  3. Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 6 Months Post-discharge

    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)

    Anxiety symptoms. Scores range from 0 (better) to 21 (worse).

  4. Change in EuroQOL-5DL (Quality of Life) Scale at 3 Months Post-discharge

    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)

    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).

  5. Change in EuroQOL-5DL (Quality of Life) Scale at 6 Months Post-discharge

    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)

    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).

  6. Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge

    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)

    Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use

  7. Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge

    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)

    Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use

Other outcomes

  1. Healthcare Utilization

    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), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)

    Hospital readmissions and clinic visits during follow up

  2. Intervention Adherence as Measured by Percentage of Tasks Completed

    Time frame: T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)

    Tasks include intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Acronym: LIFTCOVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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