Positive Health Online

Abstract

COX and COLLEAGUES,  (1)Division of Pulmonary and Critical Care Medicine, Duke University, Durham, North Carolina. (2)Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, North Carolina.; (3)Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina; (4)Duke Global Health Institute, Duke University, Durham, North Carolina; (5)Center of Innovation, Durham Veterans Affairs Medical Center, Veterans Administration, Durham, North Carolina; (6)Department of Psychiatry & Behavioral Sciences, Duke University, Durham, North Carolina.; (7)Department of Psychology, Rowan University, Glassboro, New Jersey.(8)Department of Medical Informatics and Clinical Epidemiology, Oregon Health &  Science University, Portland. (9)Division of Pulmonary Sciences and Critical Care Medicine, University of  Colorado School of Medicine, Aurora. (10)Department of Medicine, Oregon Health & Science University, Portland. determined the optimal method for delivering a mindfulness intervention via a mobile app for critical illness survivors.

Background

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.

Methodology

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 post discharge 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).

Conclusion

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. 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.

References

Cox CE(1)(2), Gallis JA(3)(4), Olsen MK(3)(5), Porter LS(6), Gremore T(6), Greeson JM(7), Morris C(8), Moss M(9), Hough CL(10). Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial. JAMA Intern Med.  184(7):749-759. DOI:10.1001/jamainternmed.2024.0823 . Jul 1; 2024. Comment on  JAMA Intern Med. 2024 Jul 1;184(7):760. DOI:10.1001/jamainternmed.2024.0833