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NCT07634419 · ClinicalTrials.gov registry record · NA
Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress
A NA study, sponsored by Duke University.
- Not yet
- Registry status
- NA
- Development phase
- 450
- Enrollment target
NCT07634419: Clinical Trial NA study, sponsored by Duke University.
NCT07634419 is a NA study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 450 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07634419, a NA study, has not yet begun recruiting, sponsored by Duke University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Lift mobile mindfulness
- BEHAVIORAL Enlighten Recovery education program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2027-01-01 |
| Est. Completion | 2031-05-31 |
| Phase | NA |
What is known before NCT07634419 opens enrollment
NCT07634419 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Lift mobile mindfulness is the first listed.
NCT07634419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07634419 about?
NCT07634419 is a clinical study titled "Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress". 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 addres...
What is the current status of trial NCT07634419?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 450 participants. The study started on 2027-01-01. Estimated completion is 2031-05-31.
What interventions are being tested in trial NCT07634419?
The interventions under investigation include: Lift mobile mindfulness (BEHAVIORAL), Enlighten Recovery education program (BEHAVIORAL).
Who is sponsoring clinical trial NCT07634419?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07634419's enrollment target sits among peer trials
450 225th of 2000 higher than 1,768 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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