Original Investigation
May 28, 2024
Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial
Christopher E. Cox, John A. Gallis, Maren K. Olsen, et al
JAMA Intern Med. Published online May 28, 2024. doi:10.1001/jamainternmed.2024.0823
Question What is the optimal method for delivering a mobile app–based mindfulness program for intensive care unit survivors?
Findings In this randomized clinical trial with 247 participants, the effect of 3 components (introduction to the program via the app vs a therapist call, twice-a-day vs once-a-day mindfulness meditation, and management of increasing depression symptoms during the intervention period by the app vs by therapist call) on depression symptoms were compared. Meditation twice a day was more effective than once a day; effects did not differ for the other 2 parameters.
Meaning In this study, an optimized version of the mindfulness intervention was fully mobile app–based and scalable to address psychological distress symptoms among intensive care unit survivors.
Abstract
Importance Although psychological distress is common among survivors of critical illness, there are few tailored therapies.
Objective To determine the optimal method for delivering a mindfulness intervention via a mobile app for critical illness survivors.
Design, Setting, and Participants This randomized clinical trial used a 2 × 2 × 2 factorial design and was conducted at 3 sites among survivors of critical illness with elevated postdischarge symptoms of depression. The study was conducted between August 2019 and July 2023.
Interventions Participants were randomized to 1 of 8 different groups as determined by 3 two-level intervention component combinations: intervention introduction method (mobile app vs therapist call), mindfulness meditation dose (once daily vs twice daily), and management of increasing symptoms (mobile app vs therapist call).
Main Outcomes and Measures The primary outcome was the 9-item Patient Health Questionnaire (PHQ-9) depression scale score (range, 0-27) at 1 month. Secondary outcomes included anxiety (7-item Generalized Anxiety Disorder) and posttraumatic stress disorder (Posttraumatic Stress Scale) symptoms at 1 and 3 months, adherence, and feasibility. General linear models were used to compare main effects and interactions of the components among intervention groups. A formal decisional framework was used to determine an optimized intervention version.
Results A total of 247 participants (mean [SD] age, 50.2 [15.4] years; 104 [42.1%] women) were randomized. Twice-daily meditation compared with once-daily meditation was associated with a 1.2 (95% CI, 0.04-2.4)–unit lower mean estimated PHQ-9 score at 1 month and a 1.5 (95% CI, 0.1-2.8)–unit lower estimated mean score at 3 months. The other 2 intervention components had no main effects on the PHQ-9. Across-group adherence was high (217 participants [87.9%] using the intervention at trial conclusion) and retention was strong (191 [77.3%] and 182 [73.7%] at 1 and 3 months, respectively).
Conclusions and Relevance A mindfulness intervention for survivors of critical illness that included an app-based introduction, twice-daily guided meditation, and app-based management of increasing depression symptoms was optimal considering effects on psychological distress symptoms, adherence, and feasibility.
Trial Registration ClinicalTrials.gov Identifier: NCT04038567
