Can a smartphone app heal the hidden wounds of the ICU?
NCT ID NCT07634419
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study tests a mobile mindfulness program called Lift for people who survived a serious illness in the ICU and now struggle with depression, anxiety, or stress. About 450 adults will use either the Lift app or a health education app for 6 months. The goal is to see if the mindfulness app improves mood and quality of life, and to make it widely available, including in Spanish.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 450 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion criteria present during hospitalization 1. Adult (age ≥18) 2. Managed in an ICU for ≥24 hours during the time inclusion criterion #3 is met 3. 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 4. Cognitive status intact o No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart 5. 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 6. 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 Exclusion Criteria: Exclusion criteria present in the hospital: 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): 1. Severe psychological distress as assessed by endorsement of active suicidality (see Protection of Human Subjects document for study team management of this finding) 2. Failure to randomize within 1 month after discharge from the hospital to home 3. Failure to login to study app and access content within 2 weeks after randomization
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Medical University of South Carolina
Charleston, South Carolina, 29403, United States
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