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

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

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

Afiliación

Cox CE; Division of Pulmonary and Critical Care Medicine (C. E. C.), the Program to Support People and Enhance Recovery (ProSPER) (C. E. C.), and the Department of Biostatistics and Bioinformatics (J. A. G. and M. K. O.), Duke University, Durham, NC; the Center of Innovation (M. K. O.), Durham Veterans Affa
Gallis JA; Division of Pulmonary and Critical Care Medicine (C. E. C.), the Program to Support People and Enhance Recovery (ProSPER) (C. E. C.), and the Department of Biostatistics and Bioinformatics (J. A. G. and M. K. O.), Duke University, Durham, NC; the Center of Innovation (M. K. O.), Durham Veterans Affa
Olsen MK; Division of Pulmonary and Critical Care Medicine (C. E. C.), the Program to Support People and Enhance Recovery (ProSPER) (C. E. C.), and the Department of Biostatistics and Bioinformatics (J. A. G. and M. K. O.), Duke University, Durham, NC; the Center of Innovation (M. K. O.), Durham Veterans Affa
Porter LS; Division of Pulmonary and Critical Care Medicine (C. E. C.), the Program to Support People and Enhance Recovery (ProSPER) (C. E. C.), and the Department of Biostatistics and Bioinformatics (J. A. G. and M. K. O.), Duke University, Durham, NC; the Center of Innovation (M. K. O.), Durham Veterans Affa
Gremore TM; Division of Pulmonary and Critical Care Medicine (C. E. C.), the Program to Support People and Enhance Recovery (ProSPER) (C. E. C.), and the Department of Biostatistics and Bioinformatics (J. A. G. and M. K. O.), Duke University, Durham, NC; the Center of Innovation (M. K. O.), Durham Veterans Affa
Iwashyna TJ; Division of Pulmonary and Critical Care Medicine (C. E. C.), the Program to Support People and Enhance Recovery (ProSPER) (C. E. C.), and the Department of Biostatistics and Bioinformatics (J. A. G. and M. K. O.), Duke University, Durham, NC; the Center of Innovation (M. K. O.), Durham Veterans Affa
Caldwell ES; Division of Pulmonary and Critical Care Medicine (C. E. C.), the Program to Support People and Enhance Recovery (ProSPER) (C. E. C.), and the Department of Biostatistics and Bioinformatics (J. A. G. and M. K. O.), Duke University, Durham, NC; the Center of Innovation (M. K. O.), Durham Veterans Affa
Greeson JM; Division of Pulmonary and Critical Care Medicine (C. E. C.), the Program to Support People and Enhance Recovery (ProSPER) (C. E. C.), and the Department of Biostatistics and Bioinformatics (J. A. G. and M. K. O.), Duke University, Durham, NC; the Center of Innovation (M. K. O.), Durham Veterans Affa
Moss M; Division of Pulmonary and Critical Care Medicine (C. E. C.), the Program to Support People and Enhance Recovery (ProSPER) (C. E. C.), and the Department of Biostatistics and Bioinformatics (J. A. G. and M. K. O.), Duke University, Durham, NC; the Center of Innovation (M. K. O.), Durham Veterans Affa
Hough CL; Division of Pulmonary and Critical Care Medicine (C. E. C.), the Program to Support People and Enhance Recovery (ProSPER) (C. E. C.), and the Department of Biostatistics and Bioinformatics (J. A. G. and M. K. O.), Duke University, Durham, NC; the Center of Innovation (M. K. O.), Durham Veterans Affa

CHEST Crit Care ; 2(2)2024 Jun.

Article en En | MEDLINE | ID: mdl-38957856

ABSTRACT

ABSTRACT

BACKGROUND:

Psychological distress symptoms are present and persistent among many patients who survive a critical illness like COVID-19. RESEARCH QUESTION Could a self-directed mobile app-delivered mindfulness intervention be feasibly and rapidly implemented within a clinical trials network to reduce distress symptoms? STUDY DESIGN AND

METHODS:

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.

RESULTS:

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.

INTERPRETATION:

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. TRIAL REGISTRATION ClinicalTrials.gov; No. NCT04581200; URL www.clinicaltrials.gov.

Palabras clave

COVID-19; critical illness; mobile app; post-intensive care unit syndrome; psychological distress

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