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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

Qualifiers

Adult (age ≥18)

Managed in an ICU for ≥24 hours during the time inclusion criterion #3 is met

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Lift mobile mindfulness
  • Enlighten Recovery education program

Treatment groups

450 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Center for Complementary and Integrative Health (NCCIH)

Collaborator