Mindfulness for Uveitis

(MARiGOLD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Nisha Acharya, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

Must not be taking: Antidepressants, Antianxiety, Psychiatric

Disqualifiers: Under 18, Psychotherapy, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Mindfulness for Uveitis is an effective treatment?

The available research shows that stress levels in patients with uveitis can be significant, especially in those with active uveitis. Since mindfulness practices are known to help reduce stress, they could be beneficial for these patients. One study found that 18% of uveitis patients had raised stress levels, similar to the general population, but those with active uveitis were more stressed. This suggests that managing stress through mindfulness could be an important part of treating uveitis. ^{1 2 3 4 5}

What safety data exists for mindfulness treatment for uveitis?

The provided research does not contain any safety data specifically related to mindfulness treatment for uveitis or the Calm Health smartphone application. The studies focus on other treatments and factors related to uveitis, such as Echinacea purpurea extract, Chinese medicines, stress levels, and treatment exit strategies. Therefore, no safety data for mindfulness or the Calm Health app is available in the given research. ^{4 5 6 7 8}

Is the Calm Health smartphone app a promising treatment for uveitis?

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 worsen uveitis, and the app is designed to reduce stress, potentially improving the quality of life for patients. ^{1 4 5 9 10}

Eligibility Criteria

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 am 18 years old or older.

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

Trial Timeline

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

Treatment Details

Interventions

• Calm Health - smartphone application (Behavioural Intervention)

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.

Participant Groups

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, Australia 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

🇦🇺 Approved in Australia as Calm for:

• Anxiety
• Stress relief
• Sleep improvement

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCSF San Francisco, CA

Who Is Running the Clinical Trial?

University of California, San Francisco Lead Sponsor

Calm.com, Inc. Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Anxiety and depression in patients with uveitis: a comprehensive review of observational studies. [2023] The purpose of this review is to provide a comprehensive summary of observational studies evaluating anxiety and depression in patients with uveitis.

2. China pubmed.ncbi.nlm.nih.gov

First contact investigations and compliance to treatment in patients with uveitis. [2023] To ascertain the pattern of investigations at first contact in uveitic patients and evaluate compliance to treatment.

3. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical and visual outcomes of patients with uveitis in the mid-Atlantic United States. [2020] To report the clinical outcomes of uveitis patients at the University of Virginia.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Perceived Stress Levels in Adult Patients With Uveitis. [2020] Background: The aim of this study was to examine perceived stress levels in adult patients with uveitis. Patients and Methods: One hundred seventy-three adult consecutive uveitis patients (age range 18 to 85 years) were analyzed in a cross-sectional design for their perceived stress, according to the Perceived Stress Questionnaire (PSQ). Stress levels were classified into normal stress, moderate stress, and high stress. Results: In the majority of uveitis patients a normal stress level (82%) within the last 2 years was detected. In a subgroup analysis, perceived stress of the patients with active uveitis compared with patients with non-active uveitis was significantly higher within the last 2 years (n=80 active/n = 45 non-active; p = 0.005). Conclusions: Overall 18% of the uveitis patient had raised perceived stress, similar to the general population but patients with active uveitis were significantly more stressed. Therefore, consideration of stress levels may be important in the therapy of uveitis patients.

5. Denmark pubmed.ncbi.nlm.nih.gov

The relationship between stress and acute anterior uveitis. [2015] To examine the relationship between stress and anterior uveitis using the General Health Questionnaire (GHQ) and the Social Readjustment Rating Questionnaire (SRRQ).

6. United States pubmed.ncbi.nlm.nih.gov

Oral Echinacea purpurea extract in low-grade, steroid-dependent, autoimmune idiopathic uveitis: a pilot study. [2007] The aim of to test efficacy and safety of Echinacea purpurea (echinacea) extract in the control of low-grade uveitis.

7. United States 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. [2022] Uveitis is an inflammatory and heterogeneous ocular disorder and has a profound impact on patients' life, work and family. There are substantial costs to the countries and individuals associated with treatment of the complications of uveitis and blindness. Conventional therapies did not lead to satisfactory outcomes for uveitis and are associated with substantial adverse events (AEs). Emerging evidences have proved the important value and potential prospect of Chinese medicines and its compound in uveitis. However, although Chinese medicines are widely used in uveitis, its therapeutic effect and safety are still controversial. It is, therefore, timely to perform an objective and normative systematic review to assess the efficacy and safety of Chinese medicines in treating uveitis on current research.

8. Germany pubmed.ncbi.nlm.nih.gov

[The Treatment Exit Options for Uveitis (TOFU) Registry: Involving Patients in the Generation of Evidence]. [2021] Uveitis comprises a group of rare diseases characterised by intraocular inflammation which may cause vision impairment and blindness and mostly affects people of working age. Non-infectious uveitis involving the posterior pole or the entire eye is often treated with different immunomodulating or disease-modifying anti-rheumatic drugs (DMARDs). However, the evidence on long-term management strategies and reduction/termination of treatment is limited. To help develop treatment exit strategies for patients with quiescent uveitis on long-term DMARD treatment, the Treatment Exit Options for Non-infectious Uveitis registry was initiated by the German ophthalmological society. A key aspect of the registry is active participation of patients (patient-reported outcomes, PROs). In a pilot study involving members of patient organizations, a combination of questionnaires covering vision- and general health-related quality of life, adherence to treatment, productivity and effects of treatment were evaluated. As the pilot study showed coverage of relevant patient-related aspects of the disease and its effect on daily life, the evaluated questionnaires were implemented in the registry's patient module. The registry including the patient module uses the electronic data capture (EDC) software REDCap (Version 9, Vanderbilt University, USA). By involving patients in both conceptualization and ongoing data collection, the TOFU registry emphasizes the patients' perspectives, and the inclusion of patient-relevant evidence for such as the development of guidelines and treatment recommendations is ensured.

9. Germany pubmed.ncbi.nlm.nih.gov

[Rehabilitation-psychological aspects of uveitis]. [2015] Until today little is known about the psychosomatic aspects of uveitis. The hypothesis that stressful life events are associated with the onset of diseases and that uveitis led to poor quality of life are discussed in the actual literature. Life events (Schedule of Recent Experiences), coping strategies (Coping Questionnaire; Essen Coping Questionnaire), psychological distress (Brief Symptom Inventory), and vision-specific quality of life (National Eye Institute Visual Functioning Questionnaire) of 51 patients with uveitis and 51 strict parallel controls were compared with another. The patients scored higher on the Schedule of Recent Experiences, lower regarding different coping strategies, and they demonstrated higher psychological distress (low effects), and they demonstrated lower disease-specific quality of life (high effect). In summary an unspecific stress hypothesis was supported; future directions of investigation were discussed.

10. China pubmed.ncbi.nlm.nih.gov

Risk of anxiety and depression in patients with uveitis: a Meta-analysis. [2022] Label="AIM" NlmCategory="OBJECTIVE">To quantitatively evaluate the risk of anxiety and depression in patients with uveitis via performing a Meta-analysis.