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NCT07634419

Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
Duke University
~450 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Lift mobile mindfulnessEnlighten Recovery education program

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient Health Questionnaire 9-item depression scale (PHQ-9)
Measured over Baseline to 1 month

Conditions

Critical Illness
Heart Failure
Sepsis
Ards
Pneumonia
Trauma Injury

Explore related trials

Critical IllnessHeart FailureInjuryPneumoniaPsychological DistressRespiratory Distress Syndrome, AcuteSepticemia

Where it's being run

3 sites across 3 states
California1
North Carolina1
South Carolina1

Study leadership

  • Christopher Cox, MD, MHA, MPH · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Kristy Johnson
[email protected]
9196817232
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Eligibility criteria

Inclusion

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

What this trial measures

  • Patient Health Questionnaire 9-item depression scale (PHQ-9)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.