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Behavioural Intervention

Mindfulness for Uveitis (MARiGOLD Trial)

N/A

Recruiting

Led By Nisha Acharya, MD, MS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is 18 or older at time of enrollment

Diagnosis of non-infectious uveitis

Must not have

Is under 18 at time of enrollment

Plans to start taking a new anti-depressant, anti-anxiety, or other psychiatric medication to improve mood in the next 12 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the primary outcome will be measured at 8 weeks.

Awards & highlights

No Placebo-Only Group

Summary

"This trial will look at how a digital meditation and mindfulness program can improve mental health in patients with non-infectious uveitis."

Who is the study for?

This trial is for adults over 18 with non-infectious uveitis who can use a smartphone and read on-screen text. Participants must be willing to download and use the Calm Health app without help, but cannot have used similar apps or started new psychiatric medications or psychotherapy recently.

What is being tested?

The study tests if using the Calm Health meditation and mindfulness app can improve mental health in patients with non-infectious uveitis. It's a controlled trial where participants are randomly assigned to either start using the app or not as part of their treatment routine.

What are the potential side effects?

Since this intervention involves a digital application for meditation and mindfulness, there are no direct physical side effects expected from its use. However, individual experiences may vary when engaging with mental health practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with non-infectious uveitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I plan to start a new mood-improving medication soon.

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I have started psychotherapy in the last 3 months.

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I cannot or do not want to download the Calm Health app on my phone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this secondary outcome will be measured at 8 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this secondary outcome will be measured at 8 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this secondary outcome will be measured at 8 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety Symptoms

Secondary study objectives

Depression Symptoms

Perceived Stress

Vision-Related Quality of Life

Other study objectives

Adherence-Based Subgroup Analyses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Digital Mindfulness Intervention ArmExperimental Treatment1 Intervention

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.

Group II: Non-Intervention ArmActive Control1 Intervention

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.

0 / 6Eligibility criteria met