NCT07634419

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
61mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

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

Study Progress1%
Jun 2026May 2031

First Submitted

Initial submission to the registry

June 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2031

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2031

Last Updated

June 10, 2026

Status Verified

May 1, 2026

Enrollment Period

4.7 years

First QC Date

June 1, 2026

Last Update Submit

June 8, 2026

Conditions

ArdsCritical IllnessHeart FailureSepsisTrauma InjuryPneumonia

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 1 month

Secondary Outcomes (11)

  • Generalized Anxiety Disorder 7-item scale (GAD-7)

    Baseline to 3 months

  • Generalized Anxiety Disorder 7-item scale (GAD-7)

    Baseline to 6 months

  • The Post-Traumatic Stress Syndrome inventory (PTSS)

    Baseline to 1 month

  • The Post-Traumatic Stress Syndrome inventory (PTSS)

    Baseline to 3 months

  • The Post-Traumatic Stress Syndrome inventory (PTSS)

    Baseline to 6 months

  • +6 more secondary outcomes

Study Arms (2)

Lift mobile mindfulness

EXPERIMENTAL

Mobile app-based mindfulness program

Behavioral: Lift mobile mindfulness

Enlighten Recovery education program

ACTIVE COMPARATOR

Mobile app-based critical illness education program

Behavioral: Enlighten Recovery education program

Interventions

Lift mobile mindfulnessBEHAVIORAL

Mobile app-based mindfulness program for serious illness survivors

Lift mobile mindfulness
Enlighten Recovery education programBEHAVIORAL

Mobile app-based critical illness education program for serious illness survivors

Enlighten Recovery education program

Eligibility Criteria

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

You may qualify if:

  • Adult (age ≥18)
  • 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)
  • 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
  • +3 more criteria

You may not qualify if:

  • \. Discharged to a location other than a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Related Publications (2)

  • 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.

    PMID: 38805199BACKGROUND

  • 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

Related Links

MeSH Terms

Conditions

Critical IllnessHeart FailureSepsisAcute Lung InjuryPneumoniaAccidental Injuries

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationLung InjuryLung DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsWounds and Injuries

Study Officials

  • Christopher Cox, MD, MHA, MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristy Johnson

CONTACT

9196817232kristy.johnson@duke.edu

Christopher Cox

CONTACT

christopher.cox@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
These are self-directed interventions with self-completed surveys. As such, these elements are blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Lift intervention vs. education program control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

February 28, 2031

Study Completion (Estimated)

May 31, 2031

Last Updated

June 10, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)