Mindfulness for Uveitis

(MARiGOLD Trial)

Overseen By Jessica Shantha, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Antidepressants, Antianxiety, Psychiatric

Disqualifiers: Under 18, Psychotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a digital meditation and mindfulness app can improve mental health for individuals with non-infectious uveitis, an eye condition that causes inflammation. Participants will either use the Calm Health app for daily 10-minute sessions over eight weeks or refrain from using any meditation apps during that period. The trial targets individuals with non-infectious uveitis who are comfortable using a smartphone and do not already have a mindfulness app. As an unphased trial, it provides a unique opportunity to explore the potential mental health benefits of mindfulness for those with uveitis.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, you cannot start new psychiatric medications to improve mood within the past month or plan to start them in the next 12 weeks.

What prior data suggests that this digital mindfulness practice is safe for patients with non-infectious uveitis?

Research shows no specific safety information for the Calm Health smartphone app, used for mindfulness treatment of non-infectious uveitis (a type of eye inflammation). However, mindfulness practices like meditation and breathing exercises are generally safe and well-tolerated by most people.

Because the Calm Health app focuses on mindfulness and meditation, it is unlikely to cause physical side effects. The app aims to improve mental health and well-being through low-risk activities.

In summary, while direct safety data for this app is lacking, mindfulness practices are usually safe and manageable for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Calm Health app for uveitis because it offers a non-invasive, digital approach to managing the condition. Unlike standard treatments that often involve corticosteroids or immunosuppressive drugs, this app leverages mindfulness and meditation practices to potentially reduce inflammation and stress, which are key factors in uveitis. The convenience and accessibility of a smartphone app mean that users can easily integrate this therapy into their daily routine, potentially improving adherence and outcomes without the side effects associated with traditional medications.

What evidence suggests that this digital mindfulness intervention is effective for mental health in patients with uveitis?

Research has shown that the Calm Health app, which offers meditation and mindfulness exercises, might help manage stress related to non-infectious uveitis, an eye condition. Early data suggest it could improve vision for those with this condition. In this trial, participants in the Digital Mindfulness Intervention Arm will use the Calm Health app for at least 10 minutes daily for 8 weeks. One study found that managing stress through mindfulness can reduce symptoms and might lower the chances of uveitis recurrence. These initial findings are encouraging, suggesting the app could be a useful tool for better eye health and reduced anxiety. However, more research is needed to confirm its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Nisha Acharya, MD, MS

Principal Investigator

UCSF, Proctor Foundation

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-infectious uveitis who can use a smartphone and read on-screen text. Participants must be willing to download and use the Calm Health app without help, but cannot have used similar apps or started new psychiatric medications or psychotherapy recently.

Inclusion Criteria

Is willing to download Calm Health on their smartphone

Is able to operate a smartphone & Calm Health without assistance

I have been diagnosed with non-infectious uveitis.

Exclusion Criteria

I started a new medication for mood, anxiety, or depression in the last month.

Already has a mindfulness/meditation app on their smartphone

Is unable to operate a smartphone or read words on a screen without assistance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the digital meditation and mindfulness modules through the Calm Health platform for at least 10 minutes per day

8 weeks

Remote engagement daily

Follow-up

Participants are monitored for changes in anxiety, depression, stress, and vision-related quality of life

4 weeks

Open-label extension

Participants in the non-intervention arm gain access to the Calm Health platform

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Calm Health - smartphone application

Trial Overview The study tests if using the Calm Health meditation and mindfulness app can improve mental health in patients with non-infectious uveitis. It's a controlled trial where participants are randomly assigned to either start using the app or not as part of their treatment routine.

How Is the Trial Designed?

Group I: Digital Mindfulness Intervention Arm Experimental Treatment 1 Intervention

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.

Group II: Non-Intervention Arm Active Control 1 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.

Calm Health - smartphone application is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Calm for:

• Anxiety
• Stress relief
• Sleep improvement

Approved in European Union as Calm for:

• Anxiety
• Stress relief
• Sleep improvement

Approved in Canada as Calm for:

• Anxiety
• Stress relief
• Sleep improvement

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Calm.com, Inc.

Industry Sponsor

Trials

8

Recruited

1,500+

Published Research Related to This Trial

In a study of 644 eyes from 491 uveitis patients over 30 years, the overall best-corrected visual acuity (BCVA) remained stable, indicating that while some patients experienced visual loss, many maintained their vision over time.

Younger age, female gender, and having anterior uveitis (AU) were associated with better visual outcomes, while severe visual loss at diagnosis and ocular hypertension predicted poorer prognosis, leading to more frequent surgical interventions for those with moderate to severe visual loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and visual outcomes of patients with uveitis in the mid-Atlantic United States. Bajwa, A., Lee, CS., Patrie, J., et al.[2020]

In a study of 51 patients with uveitis compared to 51 controls, patients reported higher levels of stressful life events and psychological distress, suggesting a link between stress and the onset of uveitis.

Patients with uveitis also experienced a significantly lower quality of life related to their vision, indicating that the disease has a substantial impact on their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation-psychological aspects of uveitis]. Franke, GH., Schütte, E., Heiligenhaus, A.[2015]

In a study of 201 uveitic patients, it was found that only 38.3% of systemic investigations performed at first contact were relevant according to standard guidelines, indicating a need for better adherence to established protocols.

Approximately 22.4% of patients were non-compliant with their treatment, primarily due to inadequate counseling from physicians and busy schedules, highlighting the importance of effective communication and support for improving treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First contact investigations and compliance to treatment in patients with uveitis. Patil, A., Gupta, S., Venkatesh, P., et al.[2023]

A meta-analysis of 12 studies involving 874 patients with uveitis found a significant association between uveitis and increased risk of anxiety (SMD=0.97) and depression (SMD=0.79), indicating that these patients are at a higher risk for mental health issues.

The study revealed that the overall incidence of anxiety and depression in uveitis patients was 39% and 17%, respectively, with higher rates observed in patients with unspecified uveitis (59% anxiety, 35% depression) compared to those with anterior (33% anxiety, 15% depression) or infectious uveitis (46% anxiety, 22% depression).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of anxiety and depression in patients with uveitis: a Meta-analysis. Cui, B., Jia, HZ., Gao, LX., et al.[2022]

In a study of 173 adult uveitis patients, 82% reported normal stress levels over the past two years, indicating that most patients do not experience high stress related to their condition.

However, patients with active uveitis reported significantly higher stress levels compared to those with non-active uveitis, suggesting that managing stress may be an important aspect of their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Stress Levels in Adult Patients With Uveitis. Grajewski, RS., Boelke, AC., Adler, W., et al.[2020]

In a study of 51 patients with low-grade autoimmune uveitis, adding Echinacea purpurea extract to standard steroid treatment resulted in a significant reduction in the duration of steroid use, with patients achieving steroid-off times of 209 days for anterior uveitis and 146 days for intermediate uveitis.

Echinacea was found to be safe, with no adverse reactions reported, and it helped maintain or improve visual acuity in the majority of patients, indicating its potential as an effective adjunct therapy for managing uveitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Echinacea purpurea extract in low-grade, steroid-dependent, autoimmune idiopathic uveitis: a pilot study. Neri, PG., Stagni, E., Filippello, M., et al.[2007]

The Treatment Exit Options for Non-infectious Uveitis (TOFU) registry was established to develop strategies for safely reducing or stopping long-term DMARD treatment in patients with quiescent uveitis, emphasizing the importance of patient-reported outcomes.

A pilot study confirmed that questionnaires assessing vision-related quality of life and treatment effects were relevant, leading to their implementation in the registry to ensure that patient perspectives inform treatment guidelines and recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Treatment Exit Options for Uveitis (TOFU) Registry: Involving Patients in the Generation of Evidence]. Li, JQ., Dell, J., Höller, T., et al.[2021]

Patients with uveitis show a higher prevalence of depression compared to healthy individuals, indicating a significant mental health risk associated with this eye condition.

Symptoms of anxiety are often worse in uveitis patients, and their reduced vision-related quality of life is linked to these mental health issues, suggesting that screening for depression and anxiety could be beneficial for their overall care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety and depression in patients with uveitis: a comprehensive review of observational studies. Choo, CH., Gonzales, J., Shantha, JG.[2023]

This systematic review aims to evaluate the efficacy and safety of Chinese medicines in treating uveitis by analyzing randomized controlled trials, focusing on outcomes like best-corrected visual acuity (BCVA) and disease activity improvement.

The review will also assess the impact of Chinese medicines on laboratory efficacy indexes, visual functioning, and the need for corticosteroids or other treatments, providing a comprehensive understanding of their potential benefits and risks for uveitis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of Chinese medicines for the treatment of uveitis: A protocol for systematic review and meta-analysis. Han, M., Chen, Y., Nong, L., et al.[2022]

Patients with acute anterior uveitis (AAU) reported significantly higher stress levels compared to controls, as measured by the General Health Questionnaire (GHQ), indicating a potential link between stress and the onset of AAU.

Follow-up results showed that patients whose AAU resolved had a significant decrease in stress levels, while those with recurrent AAU had higher stress scores, suggesting that managing stress may be important for preventing recurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between stress and acute anterior uveitis. Carrim, ZI., Ahmed, TY., Taguri, AH.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06585670

Mindfulness Approach for Reducing Anxiety and Gloom in ... In collaboration with Calm Health, the investigators aim to evaluate the efficacy of Calm Health's meditation, mindfulness, and clinical programs in reducing ...

2. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2781117

CALM: A retrospective registry to characterize clinical outcome ... Preliminary data in the CALM registry database indicate effective control of non-infectious uveitis, with improved visual acuity outcomes and without major ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06585670

Mindfulness Approach for Reducing Anxiety and Gloom in ... In collaboration with Calm Health, the investigators aim to evaluate the efficacy of Calm Health's meditation, mindfulness, and clinical ...

4. withpower.com withpower.com/trial/phase-uveitis-7-2024-33804

Mindfulness for Uveitis · Info for Participants · Clinical Trial 2025 Yes, the Calm Health app could be a promising treatment for uveitis because it helps manage stress, which is linked to uveitis. Studies show that stress can ...

5. modernretina.com modernretina.com/view/asrs-2024-the-calm-study-real-world-outcomes-of-fluocinolone-acetonide-0-18-mg

ASRS 2024: The CALM study: Real-world outcomes of ... What we found, I think the biggest takeaway from this study was the rate of recurrence being significantly reduced in terms of the uveitis for ...

6. retinalphysician.com retinalphysician.com/issues/2024/julyaugust/36-month-data-from-the-calm-registry-in-uveitis-treatment/

36-month Data from the CALM Registry in Uveitis Treatment Safety data, including uveitis recurrence, optical coherence tomography (OCT), visual acuity, vitreous haze, intraocular pressure (IOP) ...

7. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2798349

CALM: 24-month safety outcomes from a real-world registry ... Safety data included intraocular pressure (IOP) elevation and rates of surgical interventions. Results : A total of 243 eyes from 182 patients received the ...