Lift Mobile Mindfulness for COVID-19 Distress Symptoms

COVID-19 Clinical Trial

— LIFTCOVID  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581200
• Other study ID #: Pro00106306
• Secondary ID: 3U01AT009974-03S
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

BLUE CORAL eligibility (the parent cohort study from which RCT participants will be recruited)

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.

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

Inclusion criteria:

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. PHQ-9 <5 at time of interview 1 month post-discharge

2. Suicidal ideation at time of interview 1 month post-discharge

Related Conditions & MeSH terms

• Cardiorespiratory Failure
• COVID-19

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado - Denver	Aurora	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Oregon Health & Sciences University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cox CE, Hough CL, Jones DM, Ungar A, Reagan W, Key MD, Gremore T, Olsen MK, Sanders L, Greeson JM, Porter LS. Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23. — View Citation

Cox CE, Olsen MK, Gallis JA, Porter LS, Greeson JM, Gremore T, Frear A, Ungar A, McKeehan J, McDowell B, McDaniel H, Moss M, Hough CL. Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial. Contemp Clin Trials. 2020 Sep;96:106119. doi: 10.1016/j.cct.2020.106119. Epub 2020 Aug 15. — View Citation

Cox CE, Porter LS, Buck PJ, Hoffa M, Jones D, Walton B, Hough CL, Greeson JM. Development and preliminary evaluation of a telephone-based mindfulness training intervention for survivors of critical illness. Ann Am Thorac Soc. 2014 Feb;11(2):173-81. doi: 10.1513/AnnalsATS.201308-283OC. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Healthcare Utilization	Hospital readmissions and clinic visits during follow up	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)
Other	Intervention Adherence as Measured by Percentage of Tasks Completed	Tasks include intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio).	T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Study website