An interventional study of Calm Health - smartphone application in Non-infectious Uveitis, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
The proposed study is a block-randomized, controlled trial to evaluate the effects of a digital meditation and mindfulness practice on mental health in patients with non-infectious uveitis.
Non-infectious uveitis is an immune-mediated inflammatory disease of the eye that can occur alone or be associated with other autoimmune diseases. This chronic condition can be isolating and complex for patients to manage, leading to increased rates of anxiety and depression symptoms in uveitis patients compared to the general population.
In collaboration with Calm Health, the investigators aim to evaluate the efficacy of Calm Health's meditation, mindfulness, and clinical programs in reducing symptoms of anxiety and depression, as well as perceived stress, in patients. Overall, the investigators aim to collect data on the value of supplementing medical care with an accessible digital mental health resource.
University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Participants in the intervention arm will be asked to engage with the digital meditation and mindfulness modules administered through the Calm Health platform for at least 10 minutes per day for 8 weeks.
Other: Calm Health - smartphone application
Participants in the non-intervention arm will not have access to the invite-only Calm Health mobile application for the first 8 weeks of the study. They will be instructed not to use any other digital mindfulness or meditation platform over the course of the study. They will be granted access to the mobile application after 8 weeks since their enrollment have elapsed.
Participants randomized to the intervention arm of the study will be given free access to a mobile phone application called Calm Health, which they will use to engage in guided meditation and mindfulness modules for at least 10 minutes per day for 8 weeks.
Anxiety Symptoms
The severity of anxiety symptoms of participants will be assessed by the 7-item Generalized Anxiety Disorder (GAD-7) questionnaire, which is a diagnostic self-report scale that can be used to screen for and assess the severity of Generalized Anxiety Disorder (GAD). The questionnaire asks the participant to self-report the frequency of 7 different anxiety symptoms on a scale of 0 (not at all) to 3 (nearly every day) over the past two weeks. Scores ranging from 0-4 represent none to minimal anxiety, scores ranging from 5-9 indicate mild anxiety, scores 10-14 indicate moderate anxiety, and scores ranging from 15-21 indicate severe anxiety. For this study, we are defining a clinically meaningful improvement in anxiety symptoms as a decrease of 2.6 points on the GAD-7, which falls within the range of values referenced in the literature.
Time frame: The primary outcome will be measured at 8 weeks.
Depression Symptoms
The severity of depressive symptoms of participants will be assessed by the 9-item Patient Health Questionnaire (PHQ-9), which is a diagnostic self-report scale that can be used to screen for and assess the severity of depression. The questionnaire asks the participant to self-report the frequency of 9 different depressive symptoms on a scale ranging from 0 ("not at all") to 3 ("nearly every day") over the last two weeks. Total scores ranging from 1- 4 indicate minimal depression, scores ranging from 5-9 indicate mild depression, scores ranging from 10-14 indicate moderate depression, scores 15-19 indicate moderately severe depression, and scores ranging from 20-27 indicate severe depression. A clinically meaningful improvement in symptoms of depression is defined as a decrease of 1.7 points on the PHQ-9.
Time frame: This secondary outcome will be measured at 8 weeks.
Perceived Stress
The severity of perceived stress in participants will be assessed by the 10-item Perceived Stress Scale (PSS-10), which is a self-report scale that can be used to evaluate the severity of stress that young people and adults aged 12 and above experience in their daily life, over the past month. The survey asks the participant about feelings related to unpredictability, overwhelm, loss of control, and coping with the pace of everyday life. The survey asks the participant to describe the frequency of these feelings on a scale ranging from 0 ("never") to 4 ("very often"). Higher scores indicate higher stress; scores ranging from 0-13 indicate low stress, scores ranging from 14-26 indicate moderate stress, and scores ranging from 27-40 indicate high perceived stress. A clinically meaningful improvement in perceived stress is defined as a decrease of 11 points on the PSS-10.
Time frame: This secondary outcome will be measured at 8 weeks.
Vision-Related Quality of Life
The vision-related quality of life of participants will be assessed by the 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25), which measures the dimensions of self-reported vision-targeted health status that are most important for patients who have chronic eye diseases. The survey is designed to measure the influence of visual disability and visual symptoms on emotional well-being, social functioning, and daily visual functioning. Scores range from 0-100, with higher scores representing a higher vision-related quality of life. A clinically meaningful improvement in vision-related quality of life is defined as increase of 14 points on the NEI VFQ-25.
Time frame: This secondary outcome will be measured at 8 weeks.
Adherence-Based Subgroup Analyses
Prespecified subgroup analyses for primary and secondary outcomes will examine the difference in mean GAD-7, PHQ-9, PSS-10, and VFQ-25 score changes between control and intervention participants at the prespecified levels of adherence: 1. Completed the required 10-minute app usage requirement for 1a) 75%, 1b) 50%, or 1c) 25% of the days within the 8-week study period. 2. Completed any minutes of app usage for 2a) 75%, 2b) 50%, or 2c) 25% of the days within the 8-week study period. An additional analysis will examine the difference in mean GAD-7, PHQ-9, PSS-10, and VFQ-25 score changes between control and intervention participants, while adjusting for total minutes of app usage over the study period as a continuous variable.
Time frame: Levels of adherence will be determined at the end of their 8-week study period.
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco