COVID-19LIFTCOVIDNCT04581200
Lift Mobile Mindfulness for COVID-19 Distress Symptoms
A study testing Lift in people with COVID-19 and Cardiorespiratory Failure, run by Duke University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Cardiorespiratory Failure
- What is being tested?
- Lift
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Jan 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Enrolled in BLUE CORAL
- 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
Who cannot join
- 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
- PHQ-9 <5 at time of interview 1 month post-discharge
- Suicidal ideation at time of interview 1 month post-discharge
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48103
University of Colorado - Denver
Aurora, Colorado, 80045
Duke University Medical Center
Durham, North Carolina, 27710
Oregon Health & Sciences University
Portland, Oregon, 97239
About this study
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
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.
Read the 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.
- Conditions
- COVID-19, Cardiorespiratory Failure
- Being tested
- Lift
- Keywords
- critical illness, psychological distress, depression, anxiety, adults
- Medical subject headings
- COVID-19, Critical Illness, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiftBehavioural
The intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lift |
| Usual care control | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Depression symptoms. Scores range from 0 (better) to 27 (worse)
Measured: 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
Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
Measured: 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
Anxiety symptoms. Scores range from 0 (better) to 21 (worse).
Measured: 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
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).
Measured: 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
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).
Measured: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge
Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use
Measured: T1 (time of randomization [i.e., 1 month post-hospital discharge), T2 (2 months post-randomization [i.e., 3 months post-hospital discharge)
Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge
Cardiopulmonary symptoms such as breathlessness, fatigue, oxygen use
Measured: T1 (time of randomization [i.e., 1 month post-hospital discharge), T3 (5 months post-randomization [i.e., 6 months post-hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start25 Jan 2021
- Primary completion30 Mar 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Christopher E Cox, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581200
- Sponsor's protocol ID
- Pro00106306
- Other IDs
- 3U01AT009974-03S1
- Acronym
- LIFTCOVID
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2020
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will follow NIH/NCCIH guidelines for data access.
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.
PubMed 24303911Cox 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.
PubMed 29793970Cox 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.
PubMed 32805434Cox 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.
PubMed 38957856
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04581200
- Acronym / sponsor ID
- LIFTCOVID / Pro00106306
- Conditions
- COVID-19, Cardiorespiratory Failure
- Keywords
- critical illness, psychological distress, depression, anxiety, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Posted 10 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Lift mobile mindfulness program | Experimental | Behavioral: LiftWill 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. |
| Usual care control | No intervention | –Usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Enrolled in BLUE CORAL
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiftThe intervention is a mobile app-based mindfulness training program designed to be used over a 1-month period. | Behavioural | Lift mobile mindfulness program |
Primary outcome
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge
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)
7 secondary outcomes
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 6 Months Post-discharge
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)
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 3 Months Post-discharge
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)
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) at 6 Months Post-discharge
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)
Change in EuroQOL-5DL (Quality of Life) Scale at 3 Months Post-discharge
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)
Change in EuroQOL-5DL (Quality of Life) Scale at 6 Months Post-discharge
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)
Number of Participants With Cardiopulmonary Symptoms at 3 Months Post-discharge
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)
Number of Participants With Cardiopulmonary Symptoms at 6 Months Post-discharge
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24303911Cox 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.
- Background: PubMed 29793970Cox 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.
- Background: PubMed 32805434Cox 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.
- Derived from this study: PubMed 38957856Cox 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will follow NIH/NCCIH guidelines for data access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher E Cox, MD principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lift in people with COVID-19 and Cardiorespiratory Failure, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-9 Item Scale (PHQ-9) Over 3 Months Post-discharge (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581200, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.