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Randomized Controlled Trial
. 2024 Jul 1;184(7):749-759.
doi: 10.1001/jamainternmed.2024.0823.

Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial

Christopher E Cox  1   2 , John A Gallis  3   4 , Maren K Olsen  3   5 , Laura S Porter  6 , Tina Gremore  6 , Jeffrey M Greeson  7 , Cynthia Morris  8 , Marc Moss  9 , Catherine L Hough  10
Affiliations
Randomized Controlled Trial

Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial

Christopher E Cox et al. JAMA Intern Med. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Gallis reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study and outside the submitted work. Dr Olsen reported receiving grants from NIH during the conduct of the study and from the Patient-Centered Outcomes Research Institute and the Department of Veterans Affairs outside the submitted work. Dr Gremore reported receiving grants from Duke University during the conduct of the study. Dr Morris reported receiving grants from NIH during the conduct of the study. Dr Moss reported receiving grants from NIH during the conduct of the study. Dr Hough reported receiving grants from NIH during the conduct of the study and from NIH, the US Centers for Disease Control and Prevention, and American Lung Association outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Diagram of Participant Flow in the Trial
eFigure 9 in Supplement 1 includes more detailed information about group allocation and retention. aOverall, 574 patients had more than 1 reason for ineligibility: 1779 had an anticipated discharge to facility; 1620 had anticipated complex medical needs; 1392 were hospitalized during the 3 months preceding current admission; 1200 had baseline severe mental illness; 930 had poor English fluency; 576 had poor cognitive status; 470 had actual or anticipated inability to complete study tasks; 400 were admitted from a facility; 248 lacked a reliable smartphone; 192 were missed; 124 died; 118 had active alcohol or drug use disorders; 83 were receiving comfort care; 28 had unstable psychiatric issues; 14 were imprisoned persons; 7 had recent traumatic events; 7 were pregnant or near delivery; 4 had medical teams that refused approach; 3 left against medical advice; and 1 transferred to another hospital. bMany approaches were by telephone during the COVID-19 pandemic when families were not allowed to visit the hospital.
Figure 2.
Figure 2.. Estimated Mean Change Scores at 1 and 3 Months by Intervention Component Group
This figure shows estimated mean change scores for the 9-item Patient Health Questionnaire (PHQ-9; depression), the 7-item Generalized Anxiety Disorder (GAD-7; anxiety), and the Post-Traumatic Stress Scale (PTSS; posttraumatic stress disorder) symptom scales by intervention component (method of introduction to the intervention, dose, and method or response to symptoms). The low level refers to app-based introduction, once-a-day meditation, and reporting persistently high symptoms via the app; the high level refers to a therapist call for the introduction, twice-a-day meditation, and reporting persistently high symptoms to a therapist. aP < .05.
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References

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