Clinical trial NCT06585670: Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases
Official title: Effects of a Digital Mindfulness and Meditation Intervention on Mental Health and Vision-Related Quality of Life in Adults With Non-infectious Uveitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-infectious Uveitis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Calm.com, Inc.
First posted: 2024-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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 \&amp; 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.

Primary outcomes:
measure: Anxiety Symptoms
timeFrame: The primary outcome will be measured at 8 weeks.
Secondary outcomes:
measure: Depression Symptoms
timeFrame: This secondary outcome will be measured at 8 weeks.
measure: Perceived Stress
timeFrame: This secondary outcome will be measured at 8 weeks.
measure: Vision-Related Quality of Life
timeFrame: This secondary outcome will be measured at 8 weeks.
Other outcomes:
measure: Adherence-Based Subgroup Analyses
timeFrame: Levels of adherence will be determined at the end of their 8-week study period.
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: UCSF, Proctor Foundation
name: Nisha Acharya, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.