Lift Mobile Mindfulness for COVID-19 Distress Symptoms (LIFTCOVID)

• ClinicalTrials.gov Identifier: NCT04581200
• Recruitment Status: Active, not recruiting
• First Posted: October 9, 2020
• Last Update Posted: February 25, 2022
• Sponsor: Duke University
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Duke University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
COVID-19; Cardiorespiratory Failure	Behavioral: Lift	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized clinical trial
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Outcomes assessor will be blinded to group assignment, as will the investigators
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: January 25, 2021
• Estimated Primary Completion Date: March 30, 2022
• Estimated Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: Lift; The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
No Intervention: Usual care control; Usual care.

Outcome Measures

Primary Outcome Measures :

1. Change in Patient Health Questionnaire-9 Item scale (PHQ-9) [ 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 Outcome Measures :

1. Change in Patient Health Questionnaire-9 Item scale (PHQ-9) [ 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) [ 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) [ 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 scale [ 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) ]
   Quality of life instrument
5. Change in EuroQOL-5DL scale [ 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) ]
   Quality of life instrument
6. Cardiopulmonary symptoms [ 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. Cardiopulmonary symptoms [ 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 Outcome Measures:

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 [ Time Frame: T2 (2 months post-randomization [i.e., 3 months post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge) ]
   Quantified by number of intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio) completed.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Colorado

University of Colorado - Denver

Aurora, Colorado, United States, 80045

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48103

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

United States, Oregon

Oregon Health & Sciences University

Portland, Oregon, United States, 97239

Sponsors and Collaborators

Duke University

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Christopher E Cox, MD; Duke University

  Study Documents (Full-Text)

Documents provided by Duke University:

Informed Consent Form  [PDF] July 19, 2021

More Information

Additional Information:

Study website 

Publications:

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.

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.

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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04581200
• Other Study ID Numbers: Pro00106306; 3U01AT009974-03S1 ( U.S. NIH Grant/Contract )
• First Posted: October 9, 2020
• Last Update Posted: February 25, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: We will follow NIH/NCCIH guidelines for data access.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: We will follow NIH guidelines.
• Access Criteria: We will follow NIH and institutional guidelines.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:

critical illness; psychological distress; depression; anxiety; adults

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases