Critical IllnessLift 3NCT07634419
Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress
A study testing Lift mobile mindfulness and Enlighten Recovery education program in people with Critical Illness and Heart Failure, run by Duke University at 3 sites in United States.
Trial summary
Serious acute heart and lung illnesses like heart failure, severe COVID, and sepsis often leave survivors struggling not only physically, but also with lasting depression, anxiety, and stress. These problems that are hard to treat because access to mental health care is often limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Heart Failure, Sepsis
- What is being tested?
- Lift mobile mindfulness and Enlighten Recovery education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2027to 31 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 (age ≥18)
- Managed in an ICU for ≥24 hours during the time inclusion criterion #3 is met
- Serious acute cardiorespiratory condition, defined as ≥1 of the following:
- mechanical ventilation via endotracheal tube for ≥4 hours
- non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure
- new use of supplemental oxygen ≥6 liters per minute (or increase in baseline continuous oxygen)
Show all 20Show fewer
- use of vasopressors for shock of any etiology
- use of inotropes for shock of any etiology
- use of pulmonary vasodilators
- use of aortic balloon pump or cardiac assist device for cardiogenic shock
- use of diuretic intravenous drip
- evidence of acute coronary ischemia (i.e., elevated troponin level, supporting EKG changes, unstable angina symptoms documented)
- urgent cardiac catheterization
- Cognitive status intact
- o No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
- Absence of severe and/or persistent mental illness
- o Treatment for severe and/or persistent mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia [as per medical record], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission
- Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys)
- Inclusion criteria present after hospital discharge (i.e., at the time of arrival home after discharge from the hospital):
- 1. Elevated baseline psychological distress symptoms, defined as a PHQ-9 score ≥5
Who cannot join
- 1. Discharged to a location other than a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)
- Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital):
- Severe psychological distress as assessed by endorsement of active suicidality (see Protection of Human Subjects document for study team management of this finding)
- Failure to randomize within 1 month after discharge from the hospital to home
- Failure to login to study app and access content within 2 weeks after randomization
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christopher Cox contact
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29403
Duke University Medical Center
Durham, North Carolina, 27710
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Matthew Modes, MD, Matthew.Modes@cshs.org
Matthew Modes, MD
About this study
Official title: Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress: Lift RCT (Lift 3)
Serious acute heart and lung illnesses like heart failure, severe COVID, and sepsis often leave survivors struggling not only physically, but also with lasting depression, anxiety, and stress. These problems that are hard to treat because access to mental health care is often limited. To help address this, the researchers created Lift, a fully automated mindfulness program designed with patient input and delivered through a mobile app. The investigators now plan a large, multi-site study to test whether Lift improves mental health and quality of life over six months compared to a critical illness education program called Enlighten Recovery. Overall the goal is to make an easy-to-use, widely accessible program available to people across the U.S., including those who speak Spanish.
Read the detailed description
Cardiorespiratory conditions such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are among the most common causes of mortality and morbidity. They are also notable for high rates of persistent psychological distress symptoms including depression, anxiety, and PTSD that worsen quality of life and outcomes of the underlying conditions. Yet there are few effective strategies able to overcome barriers of limited access to mental health care.
To address this gap, the researchers developed Lift, a completely automated and self-directed mindfulness training intervention, from the ground up with patient input. First, Lift reduced depression symptoms and improved quality of life compared to an education program control in a multicenter pilot RCT (R34 AT008819) among those recently hospitalized with serious cardiorespiratory conditions. Next, a 247-person multicenter 2x2x2 factorial optimization trial (U01 AT00974) compared 8 intervention versions differing by program introduction (app vs. therapist), dose (standard vs. high), and approach to in-the-moment symptom management (app vs. therapist). This trial demonstrated that while all versions had a strong effect on depression, anxiety, and PTSD symptoms, the high dose, app-only version was optimized for effect, adherence, and retention.
Given these promising findings, a formal test of the optimized Lift mobile mindfulness intervention's efficacy is needed. Therefore, the investigators propose a 4-site multicenter RCT with 6-month follow up among 450 cardiorespiratory failure survivors with elevated post-discharge symptoms of psychological distress. The specific aims will: (1) Test Lift vs. an education program control delivered by similar platforms on symptoms of depression, anxiety, PTSD, and quality of life; (2a) Determine patient-level characteristics associated with a greater treatment response among a priori-defined subgroups using a heterogeneity of treatment effects analysis; (2b) Explore novel adherence metrics and outcomes; and (3) Ensure off-the-shelf intervention readiness with an exploratory mixed-methods hybrid type 1 implementation framework analysis that integrates quantitative trial implementation data with semi-structured trial participant interviews.
Innovative and unique elements include a fully automated mobile health delivery system that personalizes content in response to changes in symptom trajectories, the inclusion of Spanish language versions of intervention and control programs, and strong community engagement with formalized roles. This project addresses national research priorities and could advance the field with a personalizable yet population-scalable therapy that has the potential to broadly improve mental health access.
- Conditions
- Critical Illness, Heart Failure, Sepsis, Ards, Pneumonia, Trauma Injury
- Being tested
- Lift mobile mindfulness, Enlighten Recovery education program
- Medical subject headings
- Critical Illness, Heart Failure, Sepsis, Acute Lung Injury, Pneumonia, Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lift mobile mindfulnessBehavioural
Mobile app-based mindfulness program for serious illness survivors
Enlighten Recovery education programBehavioural
Mobile app-based critical illness education program for serious illness survivors
| Study group | Role | What they receive |
|---|---|---|
| Lift mobile mindfulness | Experimental | Mobile app-based mindfulness program Receives: Behavioral: Lift mobile mindfulness |
| Enlighten Recovery education program | Active comparator | Mobile app-based critical illness education program Receives: Behavioral: Enlighten Recovery education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire 9-item depression scale (PHQ-9)
The PHQ-9 is a primary trial outcome measure and the PHQ-9 score at 1 month is the primary trial outcome (Kroenke K, et al. J Gen Intern Med 606-13, 2001). The PHQ-9 is a well-validated metric with English and Spanish versions used in thousands of RCTs. Scores can range from 0 (no depression symptoms) to 27 (serious depression symptoms). The PHQ-9 MCID is 2-4 units.
Measured: Baseline to 1 month
Secondary outcomes (11)
Generalized Anxiety Disorder 7-item scale (GAD-7)
The GAD-7, like the related PHQ-9, has excellent psychodynamic properties including reliability, test-retest stability, accuracy, responsiveness, and validity as supported by confirmatory factor analysis (Spitzer RL, et al. Arch Intern Med. 166:1092-1097, 2006). GAD-7 scores can range from 0 [no distress] to 21 [high distress]); symptom severity is interpreted as mild (5-9), moderate (10-14), and severe (15-21). The GAD-7 MCID is 2-4 units.
Measured: Baseline to 3 months
Generalized Anxiety Disorder 7-item scale (GAD-7)
The GAD-7, like the related PHQ-9, has excellent psychodynamic properties including reliability, test-retest stability, accuracy, responsiveness, and validity as supported by confirmatory factor analysis (Spitzer RL, et al. Arch Intern Med. 166:1092-1097, 2006). GAD-7 scores can range from 0 [no distress] to 21 [high distress]); symptom severity is interpreted as mild (5-9), moderate (10-14), and severe (15-21). The GAD-7 MCID is 2-4 units.
Measured: Baseline to 6 months
The Post-Traumatic Stress Syndrome inventory (PTSS)
The PTSS rates 10 post-traumatic stress symptoms (range 10 [no symptoms] to 70 [high burden of symptoms]). A score >20 represents clinically important PTSD symptoms, while a score >=34 suggests likely PTSD.(Nickel M, et al. J Int Care Med. 19:285-290, 2004; Stoll C, et al. Int Care Med. 25:697-704, 1999) Compared to DSM-IV criteria, it is 98% specific and 77% sensitive for the diagnosis of PTSD among ICU survivors.(Stoll C, et al. Int Care Med. 25:697-704, 1999) The PTSS has excellent internal consistency, reliability, and responsiveness. (Schelling G, et al. Crit Care Med. 26:651-659, 1998; Twigg E, et al. Acta Anaesth Scand. 52:202-208, 2008) Furthermore, it is short and easily understood. Although formal psychometric testing has not clearly defined the PTSS's minimal clinically important difference, a 5-unit change represents a significant change in score in a single item and will therefore be used as a benchmark for this project.
Measured: Baseline to 1 month
The Post-Traumatic Stress Syndrome inventory (PTSS)
The PTSS rates 10 post-traumatic stress symptoms (range 10 [no symptoms] to 70 [high burden of symptoms]). A score >20 represents clinically important PTSD symptoms, while a score >=34 suggests likely PTSD.(Nickel M, et al. J Int Care Med. 19:285-290, 2004; Stoll C, et al. Int Care Med. 25:697-704, 1999) Compared to DSM-IV criteria, it is 98% specific and 77% sensitive for the diagnosis of PTSD among ICU survivors.(Stoll C, et al. Int Care Med. 25:697-704, 1999) The PTSS has excellent internal consistency, reliability, and responsiveness. (Schelling G, et al. Crit Care Med. 26:651-659, 1998; Twigg E, et al. Acta Anaesth Scand. 52:202-208, 2008) Furthermore, it is short and easily understood. Although formal psychometric testing has not clearly defined the PTSS's minimal clinically important difference, a 5-unit change represents a significant change in score in a single item and will therefore be used as a benchmark for this project.
Measured: Baseline to 3 months
The Post-Traumatic Stress Syndrome inventory (PTSS)
The PTSS rates 10 post-traumatic stress symptoms (range 10 [no symptoms] to 70 [high burden of symptoms]). A score >20 represents clinically important PTSD symptoms, while a score >=34 suggests likely PTSD.(Nickel M, et al. J Int Care Med. 19:285-290, 2004; Stoll C, et al. Int Care Med. 25:697-704, 1999) Compared to DSM-IV criteria, it is 98% specific and 77% sensitive for the diagnosis of PTSD among ICU survivors.(Stoll C, et al. Int Care Med. 25:697-704, 1999) The PTSS has excellent internal consistency, reliability, and responsiveness. (Schelling G, et al. Crit Care Med. 26:651-659, 1998; Twigg E, et al. Acta Anaesth Scand. 52:202-208, 2008) Furthermore, it is short and easily understood. Although formal psychometric testing has not clearly defined the PTSS's minimal clinically important difference, a 5-unit change represents a significant change in score in a single item and will therefore be used as a benchmark for this project.
Measured: Baseline to 6 months
The EuroQOL-5D (EQ-5D)
The EQ-5D is an easily understood, validated 5-item (plus a 100-point visual analog scale) quality of life measure that has been used successfully in >100 ICU survivor studies.(EuroQOL group. Health Policy. 16:199-208, 1990; Unroe M, et al. Ann Int Med. 153:167-175, 2010) It is considered a Core Measure for ICU outcomes research.
Measured: Baseline to 1 month
The EuroQOL-5D (EQ-5D)
The EQ-5D is an easily understood, validated 5-item (plus a 100-point visual analog scale) quality of life measure that has been used successfully in >100 ICU survivor studies.(EuroQOL group. Health Policy. 16:199-208, 1990; Unroe M, et al. Ann Int Med. 153:167-175, 2010) It is considered a Core Measure for ICU outcomes research.
Measured: Baseline to 3 months
The EuroQOL-5D (EQ-5D)
The EQ-5D is an easily understood, validated 5-item (plus a 100-point visual analog scale) quality of life measure that has been used successfully in >100 ICU survivor studies.(EuroQOL group. Health Policy. 16:199-208, 1990; Unroe M, et al. Ann Int Med. 153:167-175, 2010) It is considered a Core Measure for ICU outcomes research.
Measured: Baseline to 6 months
The Patient Health Questionnaire 10-Item scale (PHQ-10)
The investigators will use the PHQ-10, which is an adaptation of the PHQ-15 (Kroenke K, et a. Psychosom Med. 64:258-66, 2002), a scale they have used successfully in past work, to assess physical symptoms across 10 domains. The PHQ-15 is reliable, responsive, and easily understood. The study team's PHQ-10 adaptation collapsed several pain items into a single item based on patient feedback. The scale is from 0 to 30.
Measured: Baseline to 1 month
The Patient Health Questionnaire 10-Item scale (PHQ-10)
The investigators will use the PHQ-10, which is an adaptation of the PHQ-15 (Kroenke K, et a. Psychosom Med. 64:258-66, 2002), a scale they have used successfully in past work, to assess physical symptoms across 10 domains. The PHQ-15 is reliable, responsive, and easily understood. The study team's PHQ-10 adaptation collapsed several pain items into a single item based on patient feedback. The scale is from 0 to 30.
Measured: Baseline to 3 months
The Patient Health Questionnaire 10-Item scale (PHQ-10)
The investigators will use the PHQ-10, which is an adaptation of the PHQ-15 (Kroenke K, et a. Psychosom Med. 64:258-66, 2002), a scale they have used successfully in past work, to assess physical symptoms across 10 domains. The PHQ-15 is reliable, responsive, and easily understood. The study team's PHQ-10 adaptation collapsed several pain items into a single item based on patient feedback. The scale is from 0 to 30, with higher scores meaning more functional issues.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion28 Feb 2031 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Lift intervention vs. education program control
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Christopher Cox, MD, MHA, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634419
- Sponsor's protocol ID
- Pro00118118
- Other IDs
- 1UG3AT013109-01
- Acronym
- Lift 3
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cox CE, Gallis JA, Olsen MK, Porter LS, Gremore T, Greeson JM, Morris C, Moss M, Hough CL. Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):749-759. doi: 10.1001/jamainternmed.2024.0823.
PubMed 38805199Cox 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 29793970
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress: Lift RCT (Lift 3)
- ClinicalTrials.gov ID
- NCT07634419
- Acronym / sponsor ID
- Lift 3 / Pro00118118
- Conditions
- Critical Illness, Heart Failure, Sepsis, Ards, Pneumonia, Trauma Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 28 Feb 2031 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Serious acute heart and lung illnesses like heart failure, severe COVID, and sepsis often leave survivors struggling not only physically, but also with lasting depression, anxiety, and stress. These problems that are hard to treat because access to mental health care is often limited. To help address this, the researchers created Lift, a fully automated mindfulness program designed with patient input and delivered through a mobile app. The investigators now plan a large, multi-site study to test whether Lift improves mental health and quality of life over six months compared to a critical illness education program called Enlighten Recovery. Overall the goal is to make an easy-to-use, widely accessible program available to people across the U.S., including those who speak Spanish.
Detailed description
Cardiorespiratory conditions such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are among the most common causes of mortality and morbidity. They are also notable for high rates of persistent psychological distress symptoms including depression, anxiety, and PTSD that worsen quality of life and outcomes of the underlying conditions. Yet there are few effective strategies able to overcome barriers of limited access to mental health care.
To address this gap, the researchers developed Lift, a completely automated and self-directed mindfulness training intervention, from the ground up with patient input. First, Lift reduced depression symptoms and improved quality of life compared to an education program control in a multicenter pilot RCT (R34 AT008819) among those recently hospitalized with serious cardiorespiratory conditions. Next, a 247-person multicenter 2x2x2 factorial optimization trial (U01 AT00974) compared 8 intervention versions differing by program introduction (app vs. therapist), dose (standard vs. high), and approach to in-the-moment symptom management (app vs. therapist). This trial demonstrated that while all versions had a strong effect on depression, anxiety, and PTSD symptoms, the high dose, app-only version was optimized for effect, adherence, and retention.
Given these promising findings, a formal test of the optimized Lift mobile mindfulness intervention's efficacy is needed. Therefore, the investigators propose a 4-site multicenter RCT with 6-month follow up among 450 cardiorespiratory failure survivors with elevated post-discharge symptoms of psychological distress. The specific aims will: (1) Test Lift vs. an education program control delivered by similar platforms on symptoms of depression, anxiety, PTSD, and quality of life; (2a) Determine patient-level characteristics associated with a greater treatment response among a priori-defined subgroups using a heterogeneity of treatment effects analysis; (2b) Explore novel adherence metrics and outcomes; and (3) Ensure off-the-shelf intervention readiness with an exploratory mixed-methods hybrid type 1 implementation framework analysis that integrates quantitative trial implementation data with semi-structured trial participant interviews.
Innovative and unique elements include a fully automated mobile health delivery system that personalizes content in response to changes in symptom trajectories, the inclusion of Spanish language versions of intervention and control programs, and strong community engagement with formalized roles. This project addresses national research priorities and could advance the field with a personalizable yet population-scalable therapy that has the potential to broadly improve mental health access.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Lift intervention vs. education program control
| Arm | Type | Receives |
|---|---|---|
| Lift mobile mindfulness | Experimental | Behavioral: Lift mobile mindfulnessMobile app-based mindfulness program |
| Enlighten Recovery education program | Active comparator | Behavioral: Enlighten Recovery education programMobile app-based critical illness education program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult (age ≥18)
- Managed in an ICU for ≥24 hours during the time inclusion criterion #3 is met
- Serious acute cardiorespiratory condition, defined as ≥1 of the following:
- Cognitive status intact
- o No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
Key exclusion criteria (5 listed)
- 1. Discharged to a location other than a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)
- Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital):
- Severe psychological distress as assessed by endorsement of active suicidality (see Protection of Human Subjects document for study team management of this finding)
- Failure to randomize within 1 month after discharge from the hospital to home
- Failure to login to study app and access content within 2 weeks after randomization
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 |
|---|---|---|
| Lift mobile mindfulnessMobile app-based mindfulness program for serious illness survivors | Behavioural | Lift mobile mindfulness |
| Enlighten Recovery education programMobile app-based critical illness education program for serious illness survivors | Behavioural | Enlighten Recovery education program |
Primary outcome
Patient Health Questionnaire 9-item depression scale (PHQ-9)
Time frame: Baseline to 1 month
The PHQ-9 is a primary trial outcome measure and the PHQ-9 score at 1 month is the primary trial outcome (Kroenke K, et al. J Gen Intern Med 606-13, 2001). The PHQ-9 is a well-validated metric with English and Spanish versions used in thousands of RCTs. Scores can range from 0 (no depression symptoms) to 27 (serious depression symptoms). The PHQ-9 MCID is 2-4 units.
11 secondary outcomes
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Baseline to 3 months
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Baseline to 6 months
The Post-Traumatic Stress Syndrome inventory (PTSS)
Time frame: Baseline to 1 month
The Post-Traumatic Stress Syndrome inventory (PTSS)
Time frame: Baseline to 3 months
The Post-Traumatic Stress Syndrome inventory (PTSS)
Time frame: Baseline to 6 months
The EuroQOL-5D (EQ-5D)
Time frame: Baseline to 1 month
The EuroQOL-5D (EQ-5D)
Time frame: Baseline to 3 months
The EuroQOL-5D (EQ-5D)
Time frame: Baseline to 6 months
The Patient Health Questionnaire 10-Item scale (PHQ-10)
Time frame: Baseline to 1 month
The Patient Health Questionnaire 10-Item scale (PHQ-10)
Time frame: Baseline to 3 months
The Patient Health Questionnaire 10-Item scale (PHQ-10)
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 38805199Cox CE, Gallis JA, Olsen MK, Porter LS, Gremore T, Greeson JM, Morris C, Moss M, Hough CL. Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):749-759. doi: 10.1001/jamainternmed.2024.0823.
- 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.
- study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Christopher Cox contact
Christopher Cox, MD, MHA, MPH principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lift mobile mindfulness and Enlighten Recovery education program in people with Critical Illness and Heart Failure, run by Duke University at 3 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 20 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristy Johnson (9196817232, kristy.johnson@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire 9-item depression scale (PHQ-9) (time frame: Baseline to 1 month). 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 NCT07634419, which also lists 2 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 8 Jul 2026.