Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress (NCT07634419) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress
United States450 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Absence of severe and/or persistent mental illness
. Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys)
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a self-directed mindfulness app to help ICU survivors with depression and psychological distress — given that my condition was one of those it's targeting, like critical illness, sepsis, or heart failure, do you think I'm the kind of patient who might benefit from this type of approach?
2The trial is measuring depression specifically using the PHQ-9 scale — should I be getting screened for depression as part of my regular follow-up care after my ICU stay, regardless of whether I join this trial?
3Since this trial is listed as 'not yet recruiting,' are there other existing programs or evidence-based treatments for post-ICU psychological distress I should be considering right now while I wait?
4A mobile mindfulness app is designed to be self-directed, meaning I'd work through it on my own — given everything I'm managing in my recovery, do you think I have the energy and support at home to engage with something like that?
5Is this kind of psychological support something you'd recommend alongside my physical recovery care, or would you suggest I focus on one before the other?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Health Questionnaire 9-item depression scale (PHQ-9)
. 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