Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases

NCT06585670 | Active Not Recruiting

• 1 other identifier: 23-38336
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-infectious Uveitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Depression Symptoms

  This secondary outcome will be measured at 8 weeks.

• Perceived Stress

  This secondary outcome will be measured at 8 weeks.

• Vision-Related Quality of Life

  This secondary outcome will be measured at 8 weeks.

Other Outcomes (1)

• Adherence-Based Subgroup Analyses

  Levels of adherence will be determined at the end of their 8-week study period.

Study Arms (2)

Digital Mindfulness Intervention Arm

EXPERIMENTAL

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

Non-Intervention Arm

NO 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.

Interventions

Calm Health - smartphone application OTHER

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.

Digital Mindfulness Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Calm.com, Inc.: collaborator

Study Sites (1)

UCSF

San Francisco, California, 94158, United States

Location

Related Publications (2)

• 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.

  PMID: 29766596 BACKGROUND

• 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.

  PMID: 31201795 BACKGROUND

Study Officials

• Nisha Acharya, MD, MS

  UCSF, Proctor Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: August 26, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)