NCT04581200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 10, 2023

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

October 4, 2020

Results QC Date

March 21, 2023

Last Update Submit

October 19, 2023

Conditions

COVID-19Cardiorespiratory Failure

Keywords

critical illnesspsychological distressdepressionanxietyadults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

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

    T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)

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

    T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)

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

    T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)

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

    T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)

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

    T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)

  • +2 more secondary outcomes

Other Outcomes (2)

  • Healthcare Utilization

    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)

  • Intervention Adherence as Measured by Percentage of Tasks Completed

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

Study Arms (2)

Lift mobile mindfulness program

EXPERIMENTAL

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

Usual care control

NO INTERVENTION

Usual care.

Interventions

LiftBEHAVIORAL

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

Lift mobile mindfulness program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • PHQ-9 \<5 at time of interview 1 month post-discharge
  • Suicidal ideation at time of interview 1 month post-discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Colorado - Denver

Aurora, Colorado, 80045, United States

Location

University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oregon Health & Sciences University

Portland, Oregon, 97239, United States

Location

Related Publications (4)

  • 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.

    PMID: 24303911BACKGROUND

  • 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.

    PMID: 29793970BACKGROUND

  • 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.

    PMID: 32805434BACKGROUND

  • Cox CE, Gallis JA, Olsen MK, Porter LS, Gremore TM, Iwashyna TJ, Caldwell ES, Greeson JM, Moss M, Hough CL. Mobile App-Based Mindfulness Intervention for Addressing Psychological Distress Among Survivors of Hospitalization for COVID-19 Infection. CHEST Crit Care. 2024 Jun;2(2):100063. doi: 10.1016/j.chstcc.2024.100063. Epub 2024 Mar 4.

    PMID: 38957856DERIVED

Related Links

MeSH Terms

Conditions

COVID-19Critical IllnessDepressionAnxiety Disorders

Interventions

Lifting

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Results Point of Contact

Title
Christopher Cox
Organization
Duke University
christopher.cox@duke.edu
9196817232

Study Officials

  • Christopher E Cox, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Outcomes assessor will be blinded to group assignment, as will the investigators
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2020

First Posted

October 9, 2020

Study Start

January 25, 2021

Primary Completion

March 30, 2022

Study Completion

May 30, 2022

Last Updated

November 7, 2023

Results First Posted

May 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

We will follow NIH/NCCIH guidelines for data access.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
We will follow NIH guidelines.
Access Criteria
We will follow NIH and institutional guidelines.

Locations

US(4)