Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases (NCT06585670) | Clinical Trial Compass
CompletedNot Applicable
Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases
United States100 participantsStarted 2024-08-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial specifically studied people with non-infectious uveitis — is that the exact type of uveitis I have, and does that affect whether its findings might be relevant to my situation?
2The trial used a mindfulness-based approach to reduce anxiety in uveitis patients — how significant is anxiety as a concern in my own case, and is this something worth addressing alongside my physical eye treatment?
3Since this trial is now completed, has my doctor seen or can they help me find the results, and do those results suggest mindfulness actually helped reduce anxiety symptoms in uveitis patients?
4This was listed as Phase NA, meaning it wasn't testing a drug but rather a behavioral or psychological approach — does that mean there are fewer safety concerns compared to a medication trial, and could something like this be combined with my current uveitis treatment?
5Are there already established anxiety support programs or mindfulness resources available to me now without joining a trial, or would my doctor recommend waiting to see the published results of this study before trying a similar approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anxiety Symptoms
Timeframe: The primary outcome will be measured at 8 weeks.