The Effects of a Digital Mindfulness Intervention on Mental Health and Vision-Related Quality of Life in Non-infectious Uveitis.

Objective: To evaluate the effect of a digital mindfulness-based program (Calm Health) on mental health outcomes in adults with non-infectious uveitis (NIU).

Design: Single-center, single-masked, waitlist-controlled randomized clinical trial.

Participants: One hundred adults aged ≥18 years with active or inactive NIU and baseline mild or greater anxiety or depression were randomized 1:1 to immediate access to a mindfulness app (Calm Health) or to a waitlist control group.

Methods: Participants in the intervention group were instructed to use the Calm Health mobile app for ≥10 minutes daily for 8 weeks. Controls received no new mindfulness intervention during this period. Outcomes were assessed at baseline and 8 weeks using validated surveys. MAIN OUTCOME MEASURES The primary outcome was the mean difference in the anxiety symptom severity score measured by the Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks. Secondary outcomes included changes in depression (Patient Health Questionnaire-9 [PHQ-9]), perceived stress (Perceived Stress Scale-10 [PSS-10]), and vision-related quality of life (National Eye Institute Visual Function Questionnaire-25 [NEI VFQ-25]). Outcomes were analyzed using linear analysis of covariance (ANCOVA) models, adjusting for baseline scores.

Results: Of 100 randomized participants (median age 43.5 years; 75% female), 70 completed the primary endpoint assessment. Median [Q1, Q3] total app use among intervention participants was 579 [397.79, 923.00] minutes over 8 weeks. After adjustment for baseline scores, the intervention group had a significantly lower GAD-7 score at 8 weeks compared with controls (mean difference -1.7 points; 95% CI: -3.17, -0.23, p=0.02). Secondary analyses showed significantly greater reductions in PHQ-9 scores (-1.90 points; 95% CI: -3.04, -0.76, p=0.001) and PSS-10 scores (-3.69 points; 95% CI: -6.00, -1.37, p=0.002) in the intervention group. Changes in NEI VFQ-25 scores were not statistically significant between groups (mean difference 1.98 points; 95% CI: -0.90, 4.86, p=0.18). Sensitivity analyses accounting for missing data and clinical covariates yielded similar results.

Conclusions: A digital mindfulness-based intervention (Calm Health) significantly reduced anxiety, depression, and perceived stress in adults with NIU. Digital mindfulness tools may serve as a feasible, scalable adjunct to uveitis care, particularly in settings with limited access to traditional mental health services.