Mobile app-based mindfulness intervention for addressing psychological distress among survivors of hospitalization for COVID-19 infection

Importance Psychological distress symptoms are present and persistent among many patients who survive a critical illness like COVID-19. Objective To determine if a self-directed mobile app-delivered mindfulness intervention could be feasibly and rapidly implemented within a clinical trials network to reduce distress symptoms. Design Setting, and Participants: Randomized clinical trial was conducted between January 2021 and May 2022 at 29 US sites and included survivors of hospitalization due to COVID-related illness with elevated symptoms of depression at discharge. Interventions 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. Main Outcomes and Measures The primary outcome was depression symptoms assessed with the Patient Health Questionnaire 9-item scale (PHQ-9) at 3 months. Secondary outcomes included anxiety (Generalized Anxiety Disorder 7-item scale [GAD-7], quality of life (EuroQOL Five-Dimension Scale [EQ5D], and adherence. We used general linear models to estimate treatment arm differences in outcomes over time. Results Among 56 randomized participants (mean age, 51.0 [SD 13.2], female, 38 [67.9%]; Black race, 14 [25%]), 45 (intervention 23 [79%] and control 22 [81%]) were retained at 6 months. There was no difference in mean improvement between intervention and control participants at 3 months in PHQ-9 (-0.5 vs. 0.1), GAD-7 (-0.3 vs. 0.1), or EQ5D (-0.03 vs. 0.02) scores; 6 month results were similar. Only 15 (51.7%) participants initiated the intervention while the mean number of the 56 prescribed intervention activities completed was 12.0 (SD 15.2). Regulatory approvals delayed trial initiation by nearly a year. Conclusions and Relevance 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.