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

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Non-infectious Uveitis

Treatments: Other: Calm Health - smartphone application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06585670

23-38336

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups

Digital Mindfulness Intervention Arm

Experimental group

Description:

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.

Treatment:

Other: Calm Health - smartphone application

Non-Intervention Arm

No Intervention group

Description:

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.