NCT04581200: LIFTCOVID

Lift Mobile Mindfulness for COVID-19 Distress Symptoms

Completed NA Results posted Last updated 7 November 2023

What this trial tests

NA trial testing Lift in COVID-19 in 56 participants. Completed in 30 May 2022.

Timeline

25 January 2021

Primary endpoint
30 March 2022

30 May 2022

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	56
Start date	25 January 2021
Primary completion	30 March 2022
Estimated completion	30 May 2022
Sites	4 locations across United States

Drugs / interventions tested

• Lift

Conditions studied

• COVID-19 — all drugs for COVID-19 →
• Cardiorespiratory Failure — all drugs for Cardiorespiratory Failure →

Sponsor

Duke University

Who can join

18 and older, any sex, with COVID-19 or Cardiorespiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Lift Mobile Mindfulness Program	0.09	± 3.22
Usual Care Control	-0.50	± 4.31

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

Group	Value	95% CI
Lift Mobile Mindfulness Program	-0.63	± 5.76
Usual Care Control	-0.84	± 4.71

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

Group	Value	95% CI
Lift Mobile Mindfulness Program	0.09	± 4.76
Usual Care Control	-0.27	± 5.29

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

Group	Value	95% CI
Lift Mobile Mindfulness Program	0.26	± 4.83
Usual Care Control	0.68	± 4.57

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

Group	Value	95% CI
Lift Mobile Mindfulness Program	0.02	± 0.19
Usual Care Control	-0.03	± 0.25

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

Group	Value	95% CI
Lift Mobile Mindfulness Program	0.6	± 0.36
Usual Care Control	0.66	± 0.28

Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge Secondary · 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

Group	Value	95% CI
Lift Mobile Mindfulness Program	10
Usual Care Control	4

Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge Secondary · 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

Group	Value	95% CI
Lift Mobile Mindfulness Program	8
Usual Care Control	9

Intervention Adherence as Measured by Percentage of Tasks Completed Secondary · 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).

Group	Value	95% CI
Lift Mobile Mindfulness Program	23.0	± 29.3

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mobile App-Based Mindfulness Intervention for Addressing Psychological Distress Among Survivors of Hospitalization for COVID-19 Infection.
   Cox CE, Gallis JA, Olsen MK, Porter LS, et al · · 2024 · cited 2× · PMID 38957856 · DOI 10.1016/j.chstcc.2024.100063