A Mobile App for Stress Management in Middle-Aged Men and Women (Calm): Feasibility Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Middle-aged adults (40 to 65 years) report higher stress than most age groups. There is a need to test the feasibility of using a meditation app to reduce stress and improve stress-related outcomes in both middle-aged men and women. OBJECTIVE Therefore, the purpose of this study was to: (1) determine the feasibility (i.e., acceptability and demand) of a consumer-based meditation app (i.e., Calm) to reduce stress in middle-aged adults reporting elevated stress; and (2) explore the preliminary effects of Calm on perceived stress, psychological outcomes (i.e., anxiety, depressive symptoms, mindfulness, general coping), health behaviors (i.e., physical activity, eating habits), and perceptions of COVID-19. METHODS The current study is a double-blind randomized controlled feasibility study testing a brief app-based meditation (i.e., Calm) intervention in middle-aged adults (N=83) with elevated stress levels (i.e., score greater than or equal to 15 on the Perceived Stress Scale) and limited or no previous experience with meditation. Participants were randomized to an app-based meditation intervention (Calm) or app-based education control group (POD). Participants completed self-report assessments at baseline and post-intervention (Week 4). Feasibility was measured as acceptability and demand using Bowen’s framework. Feasibility and COVID-19 perceptions data were examined via descriptive statistics. Preliminary effects were examined using repeated-measures analysis of variance. RESULTS Participants were satisfied with the meditation intervention (96.4%; 27/28) and found it appropriate/useful (92.9%; 26/28). Most reported that they were likely to continue using Calm in the future (64.3%; 18/28). More participants in the Calm group reported satisfaction, appropriateness/usefulness, and intent to continue use compared to the control. Calm participants (n=33) averaged 20.0±31.1 minutes of meditation on the days they meditated and 103±109.1 minutes of meditation per week during the study. On average there was a 70.8% adherence rate to the prescribed meditation, compared to 62.2% in POD. Recruitment of men into the study was 34.9% (29/83). Of those randomized to Calm, 55.2% (15/29) were men. Retention among men was 93.3% (14/15) compared to 60% (12/20) for women. No significant within or between group differences in stress or psychological outcomes related to stress were observed nor were significant differences in health behaviors related to stress. CONCLUSIONS A four-week, app-based mindfulness meditation intervention (i.e., Calm) may be feasible in middle-aged adults. Calm participants expressed satisfaction with the intervention and felt it was appropriate and useful. However, significant improvements in perceived stress and psychological outcomes (i.e., anxiety, depressive symptoms, mindfulness and general coping) or health behaviors related to stress (i.e., physical activity, eating habits) were not observed. The majority of participants reported that COVID-19 negatively impacted their stress, mental health, and physical health. More research is needed for improving stress and stress related outcomes in middle-aged men and women using mindfulness meditation apps. CLINICALTRIAL ClinicalTrials.gov NCT04272138; http://clinicaltrials.gov/ct2/show/NCT04272138.