Clinical trial NCT04581200: Lift Mobile Mindfulness for COVID-19 Distress Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Cardiorespiratory Failure
Keywords: critical illness
psychological distress
depression
anxiety
adults
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-10-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 6 Months Post-discharge
timeFrame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
measure: Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 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)
measure: Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 6 Months Post-discharge
timeFrame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
measure: Change in EuroQOL-5DL (Quality of Life) Scale at 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)
measure: Change in EuroQOL-5DL (Quality of Life) Scale at 6 Months Post-discharge
timeFrame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
measure: Number of Participants With Cardiopulmonary Symptoms at 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)
measure: Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge
timeFrame: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Other outcomes:
measure: Healthcare Utilization
timeFrame: 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)
measure: Intervention Adherence as Measured by Percentage of Tasks Completed
timeFrame: T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Locations:
city: Aurora
country: United States
facility: University of Colorado - Denver
state: Colorado
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
Study officials:
affiliation: Duke University
name: Christopher E Cox, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.