Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases (MARiGOLD)

Effects of a Digital Mindfulness and Meditation Intervention on Mental Health and Vision-Related Quality of Life in Adults With Non-infectious Uveitis

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.

Study Overview

• Status: Completed
• Conditions: Non-infectious Uveitis
• Intervention / Treatment: Other: Calm Health - smartphone application

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • UCSF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Is 18 or older at time of enrollment.
• Is willing to download Calm Health on their smartphone
• Is able to operate a smartphone & Calm Health without assistance
• Is able to read words on a screen without assistance
• Diagnosis of non-infectious uveitis

Exclusion Criteria:

• Is under 18 at time of enrollment.
• Has started taking a new anti-depressant, anti-anxiety, or other psychiatric medication to improve mood within the past month.
• Plans to start taking a new anti-depressant, anti-anxiety, or other psychiatric medication to improve mood in the next 12 weeks.
• Has started any type of psychotherapy within the past 3 months.
• Plans to start any type of psychotherapy within the next 12 weeks.
• Already has a mindfulness/meditation app on their smartphone.
• Is unable to operate a smartphone or read words on a screen without assistance.
• Is unable or unwilling to download the Calm Health app on their smartphone.
• Does not consent to their anonymized data being collected via Calm Health app.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Mindfulness Intervention Arm; 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 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.
No Intervention: Non-Intervention Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The primary outcome will be measured at 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	This secondary outcome will be measured at 8 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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.; 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.	Levels of adherence will be determined at the end of their 8-week study period.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Calm.com, Inc.
• Investigators: Principal Investigator: Nisha Acharya, MD, MS, UCSF, Proctor Foundation

Publications and helpful links

General Publications

• Rosen KD, Paniagua SM, Kazanis W, Jones S, Potter JS. Quality of life among women diagnosed with breast Cancer: A randomized waitlist controlled trial of commercially available mobile app-delivered mindfulness training. Psychooncology. 2018 Aug;27(8):2023-2030. doi: 10.1002/pon.4764. Epub 2018 Jun 1.
• Niemeyer KM, Gonzales JA, Doan T, Browne EN, Rao MM, Acharya NR. Time Trade-off Utility Values in Noninfectious Uveitis. Am J Ophthalmol. 2019 Dec;208:47-55. doi: 10.1016/j.ajo.2019.06.005. Epub 2019 Jun 13.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: 23-38336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No