Effects of a Digital Mindfulness and Meditation Intervention on Mental Health and Vision-Related Quality of Life in Adults With Non-infectious Uveitis
Overview
- Phase
- Not Applicable
- Intervention
- Calm Health - smartphone application
- Conditions
- Non-infectious Uveitis
- Sponsor
- University of California, San Francisco
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Anxiety Symptoms
- Status
- Completed
- Last Updated
- 29 days ago
Overview
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.
Investigators
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 \& 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.
Arms & Interventions
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.
Intervention: Calm Health - smartphone application
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.
Outcomes
Primary Outcomes
Anxiety Symptoms
Time Frame: The primary outcome will be measured at 8 weeks.
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.
Secondary Outcomes
- 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.)