Digital mindfulness app reduces anxiety, depression in uveitis

A randomized trial found that 8 weeks of daily use of the Calm Health app significantly improved mental health outcomes in adults with non-infectious uveitis.

Can a smartphone app meaningfully address the psychological burden of chronic ocular inflammatory disease? That question prompted the MARiGOLD (Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases) trial (NCT06585670), in which Shantha and colleagues evaluated whether a digital mindfulness-based intervention could reduce anxiety, depression, and perceived stress in adults with non-infectious uveitis (NIU).¹ A prior meta-analysis found that roughly 39% of patients with uveitis experience anxiety and 17% experience depression, rates far exceeding global prevalence estimates of 7% and 6%, respectively.²,³ Stress levels have also been reported as elevated in this population relative to controls.⁴ Despite these figures, mental health interventions have received limited study in patients with ocular inflammatory disease.

Shantha and colleagues designed the MARiGOLD trial as a single-center, single-masked, waitlist-controlled randomized clinical trial conducted at the F.I. Proctor Foundation Uveitis Clinic at the University of California, San Francisco. Adults aged 18 years or older with active or inactive NIU were eligible if they reported at least mild anxiety or depression at baseline, defined as a score of 5 or higher on the Generalized Anxiety Disorder-7 (GAD-7) and/or Patient Health Questionnaire-9 (PHQ-9). Those who had recently started or planned to initiate psychiatric medication or psychotherapy, or who were already using a mindfulness app on a regular basis, were excluded.¹

One hundred participants were randomly assigned 1:1 to immediate access to the Calm Health mobile application or to a waitlist control group. Unlike the consumer-facing Calm app, Calm Health is an invitation-only clinical platform offering evidence-based guided meditation and mindfulness programming rooted in cognitive behavioral therapy and dialectical behavior therapy, with content tailored to each user's mental health screening profile. Those in the intervention arm were asked to use the app for a minimum of 10 minutes per day over 8 weeks; waitlist participants were asked to hold off on any new mindfulness practices for the same duration.¹

The primary outcome was GAD-7 anxiety severity at 8 weeks. Secondary measures included PHQ-9 depression scores, Perceived Stress Scale-10 (PSS-10) scores, and vision-related quality of life via the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). All outcomes were analyzed using linear analysis of covariance models with adjustment for baseline scores.¹

Of the 100 randomly assigned participants—median age 43.5 years, 75% female—70 completed the primary end point assessment at 8 weeks. Intervention participants logged a median of approximately 579 minutes of total app use over the study period. At week 8, the intervention group showed a significantly lower GAD-7 score than controls after adjusting for baseline severity (mean difference −1.7 points; 95% CI, −3.17 to −0.23; P = .02). While this margin falls short of commonly cited minimal clinically important difference benchmarks for the GAD-7, participants in the intervention arm achieved a median within-arm reduction of 4 points from baseline. Shantha and colleagues noted that in cohorts with mild baseline anxiety—as seen here, with a median baseline GAD-7 score of 7.0—smaller absolute between-group differences may still carry clinical relevance based on baseline-dependent modeling.¹

Results for secondary outcomes were consistent with the primary outcome. Compared with controls, intervention participants showed greater reductions in PHQ-9 scores (mean difference −1.90 points; 95% CI, −3.04 to −0.76; P = .001) and PSS-10 scores (mean difference −3.69 points; 95% CI, −6.00 to −1.37; P = .002). NEI VFQ-25 scores trended upward in the intervention group but did not reach statistical significance (mean difference 1.98 points; 95% CI, −0.90 to 4.86; P = .18). The authors pointed to prior evidence that this instrument responds more readily to changes in ocular status than to psychological interventions in patients with uveitis, and noted that a ceiling effect may have limited measurable gains in a cohort where disease was largely controlled and baseline visual acuity was high. Sensitivity analyses adjusting for missing data, systemic autoimmune disease, corticosteroid use, and other immunosuppressive therapies returned findings in line with the primary results.¹

Shantha and colleagues noted several constraints on interpretation. Because the trial used a waitlist rather than an active comparator, it cannot isolate effects specific to mindfulness from those attributable to structured engagement or attention alone. Participants and coordinators were aware of treatment assignment, which may have shaped self-reported outcomes through expectancy. The study enrolled only English-speaking patients at one academic medical center, and the sample was too small to permit subgroup analyses by uveitis anatomic location or underlying etiology.¹

Even so, the authors concluded that a self-directed, app-based mindfulness program is a practical and acceptable option for patients with NIU and may complement standard care—especially in settings where mental health resources are scarce. Shantha and colleagues called for follow-up studies with longer observation windows, active control arms, and more diverse enrollment to clarify how durable these benefits are and which patients are most likely to benefit.¹

Jacob Lang, OD, FAAO; Selina R. McGee, OD, FAAO; Neda Shamie, MD

Arjan Hura, MD; Neda Shamie, MD; Kristin Barnes, OD

Jacob Lang, OD, FAAO; Selina R. McGee, OD, FAAO; Neda Shamie, MD

John D. Gelles, OD, FAAO, FIAOMC, FCLSA, FSLS, FBCLA; John Hovanesian, MD, FACS

Arjan Hura, MD; Neda Shamie, MD; Kristin Barnes, OD

Solange Peters, MD, PhD; Benjamin P. Levy, MD; Tony S.K. Mok, MD, BMSc, FRCP(C), FRCP(Edin), FHKCP, FHKAM(Medicine), FASCO; Maurice Pérol, MD

Mark Schaeffer, OD, FAAO; Mile Brujic, OD, FAAO; Nate Lighthizer, OD, FAAO, FAAOMS; Selina R. McGee, OD, FAAO

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Mark R. Barakat, MD, FASRS; David Eichenbaum, MD, FASRS

Ramiro Maldonado, MD; Rebecca Nelson, MS, CGC; Robert A. Sisk, MD, FACS, FASRS

David Almeida, MD, PhD, MBA; Margaret A. Chang, MD, MS; Arshad M. Khanani, MD, MA, FASRS; Jessica Randolph, MD

Dante Pieramici, MD, FASRS; Dean Eliott, MD; Robin A. Vora, MD; Charles C. Wykoff, MD, PhD, FASRS

Dilsher Dhoot, MD, FASRS; Jordana G. Fein, MD, MS; Deep Parikh, MD; Xiao-Yi (Ellie) Zhou, MD

SriniVas R. Sadda, MD, FARVO; Mark R. Barakat, MD, FASRS; David A. Eichenbaum, MD, FASRS

Stephen C. Pflugfelder, MD; Cecelia Koetting, OD, FAAO, DipABO

Stephen C. Pflugfelder, MD; Cecelia Koetting, OD, FAAO, DipABO

John Kitchens, MD; Michael W. Stewart, MD

Mile Brujic, OD, FAAO; Pierce Kenworthy, OD, FAAO; Blair Lonsberry, MS, OD, MEd, FAAO