Background: Racially and ethnically minoritized individuals (REMs) who experience discrimination are at risk of developing stress, anxiety, and depression, and digital mental health interventions (DMHIs) can make evidence-based treatments such as mindfulness available to these groups. However, REMs are significantly underrepresented in the overall DMHI and mindfulness-based DMHI literature, limiting our understanding of the effectiveness and feasibility of these digital tools to advance mental health equity for these populations. Objective: This randomized controlled trial evaluated the effectiveness of a 4-week self-guided app-based mindfulness DMHI versus treatment as usual (TAU) in reducing discrimination-related stress, anxiety, and depressive symptoms among REMs, while assessing feasibility metrics, including uptake, engagement, dropout, and program satisfaction. Methods: A total of 155 participants (mean age 27.28, SD 9.6 years) were randomized to either receive the DMHI (n=80) or TAU (n=75). Participants in the DMHI group underwent an onboarding procedure and were asked to complete 1 meditation daily for 4 weeks. Participants in the TAU group were encouraged to seek mental health services on their own. The racial and ethnic composition of the sample was 38.7% (60/155) Latinx, 37.4% (58/155) Asian, 11.6% (18/155) Black, 10.3% (16/155) Multiracial, and 2% (3/155) Native American. Mean differences between groups were examined using multilevel regression models, applying a false discovery rate (FDR) correction across all fixed effects. Treatment effect sizes and clinical significance were calculated using pseudos and the percentage of participants who achieved a minimal clinically significant difference (MCID), respectively. Feasibility outcomes were examined descriptively and included the percentage of participants who accessed the DMHI, days using it, meditations completed, total time meditated, the percentage of participants who dropped out of the study, and self-reported treatment satisfaction. Results: Compared with participants in the TAU group, participants in the DMHI group experienced greater reductions in stress (=−4.52, 95% CI –6.54 to –2.51; FDR-adjusted <.001; pseudo-=.41; MCID=61%, 49/80), anxiety (=−3.31, 95% CI –4.89 to –1.74; FDR-adjusted <.001; pseudo-=.45; MCID=48%, 38/80), and depression (=−2.84, 95% CI –4.57 to –1.12; FDR-adjusted =.004; pseudo-=.53; MCID=54%, 43/80) by the end of the program. All participants in the DMHI group downloaded the app (80/80, 100%) and used it, on average, 16.83 (SD 7.8) days, completed 24.85 (SD 23.3) mediations, and meditated 238.67 (SD 260.7) minutes. Of all participants, 12 (12/155, 8%) dropped out of this study. Most dropouts occurred in the intervention group (11/80, 14%). Participants perceived the DMHI program as satisfactory by the end of treatment (mean treatment satisfaction 23.14, SD 4.9). Conclusions: These findings position this self-guided app-based mindfulness DMHI as an effective and feasible strategy for mitigating the deleterious mental health consequences of exposure to discrimination among REMs. Trial Registration: ClinicalTrials.gov NCT05027113; https://clinicaltrials.gov/ct2/show/NCT05027113 International Registered Report Identifier (IRRID): DERR1-10.2196/35196
Rationale and methods of the MOVI-HIIT! cluster-randomized controlled trial: an avatar-guided virtual platform for classroom activity breaks and its impact on cognition, adiposity, and fitness in preschoolers
IntroductionClassroom-based active breaks (ABs) have been shown to reduce sedentary time and increase physical activity in primary school children; however, evidence regarding their effects on