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

Among survivors of COVID-19 hospitalization with elevated depression symptoms, a self-directed mobile app mindfulness intervention showed no benefit over usual care and had poor adherence. In a randomized trial at 29 US sites, 56 participants were assigned to a four-week app program or control. At three months, depression scores improved similarly in both groups (intervention -0.5 vs control +0.1), with no meaningful differences in anxiety or quality of life; six-month results were comparable. Only about half of intervention participants started the program, and adherence was low. Regulatory delays added nearly a year before the trial could launch. The findings suggest that future large-scale psychological distress interventions should prioritize patient engagement and streamlined regulatory processes.

Study at a glance

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.