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Mobile App-Based Mindfulness Intervention for Addressing Psychological Distress Among Survivors of Hospitalization for COVID-19 Infection.

Christopher E Cox, John A Gallis, Maren K Olsen, Laura S Porter, Tina M Gremore, Theodore J Iwashyna, Ellen S Caldwell, Jeffrey M Greeson, Marc Moss, Catherine L Hough

CHEST critical care June 1, 2024 DOI: 10.1016/j.chstcc.2024.100063 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized clinical trial Peer reviewed
Sample size 56
Population Survivors of hospitalization due to COVID-19-related illness with elevated symptoms of depression at discharge
Intervention self-directed mobile app-delivered mindfulness intervention
Duration 4-week intervention, 6-month follow-up
Topics Meditation
Keywords Covid-19 Critical illness Mobile app Psychological distress
Citations 3
Registration NCT04581200
Key findings A self-directed mobile app-delivered mindfulness intervention did not reduce depression, anxiety, or improve quality of life compared to usual care among survivors of COVID-19 hospitalization with elevated psychological distress, and adherence was poor.

Abstract

Psychological distress symptoms are present and persistent among many patients who survive a critical illness like COVID-19. Could a self-directed mobile app-delivered mindfulness intervention be feasibly and rapidly implemented within a clinical trials network to reduce distress symptoms? A randomized clinical trial was conducted between January 2021 and May 2022 at 29 US sites and included survivors of hospitalization due to COVID-19-related illness with elevated symptoms of depression at discharge. Participants were randomized to intervention or usual care control. The intervention consisted of four themed weeks of daily audio, video, and text content. All study procedures were virtual. The primary outcome was depression symptoms assessed with the Patient Health Questionnaire 9 at 3 months. Secondary outcomes included anxiety (Generalized Anxiety Disorder 7-item scale), quality of life (EQ-5D), and adherence. We used general linear models to estimate treatment arm differences in outcomes over time. Among 56 randomized participants (mean age ± SD, 51.0 ± 13.2 years; 38 female [67.9%]; 14 Black participants [25%]), 45 (intervention: n = 23 [79%]; control: n = 22 [81%]) were retained at 6 months. There was no difference in mean improvement between intervention and control participants at 3 months in Patient Health Questionnaire 9 (-0.5 vs 0.1), Generalized Anxiety Disorder 7-item scale (-0.3 vs 0.1), or EQ-5D (-0.03 vs 0.02) scores, respectively; 6-month results were similar. Only 15 participants (51.7%) initiated the intervention, whereas the mean number ± SD of the 56 prescribed intervention activities completed was 12.0 ± 15.2. Regulatory approvals delayed trial initiation by nearly a year. Among survivors of COVID-19 hospitalization with elevated psychological distress symptoms, a self-directed mobile app-based mindfulness intervention had poor adherence. Future psychological distress interventions mobilized at broad scale should focus efforts on patient engagement and regulatory simplification to enhance success. ClinicalTrials.gov; No.: NCT04581200; URL: www.clinicaltrials.gov.