Non-infectious UveitisMARiGOLDNCT06585670
Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases
A study testing Calm Health - smartphone application in people with Non-infectious Uveitis, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-infectious Uveitis
- What is being tested?
- Calm Health - smartphone application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Digital Mindfulness and Meditation Intervention on Mental Health and Vision-Related Quality of Life in Adults With Non-infectious Uveitis
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.
Read the 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.
- Conditions
- Non-infectious Uveitis
- Being tested
- Calm Health - smartphone application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm Health - smartphone applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary outcome will be measured at 8 weeks.
Secondary outcomes (3)
Depression Symptoms
The severity of depressive symptoms of participants will be assessed by the 9-item Patient Health Questionnaire (PHQ-9), which is a diagnostic self-report scale that can be used to screen for and assess the severity of depression. The questionnaire asks the participant to self-report the frequency of 9 different depressive symptoms on a scale ranging from 0 ("not at all") to 3 ("nearly every day") over the last two weeks. Total scores ranging from 1- 4 indicate minimal depression, scores ranging from 5-9 indicate mild depression, scores ranging from 10-14 indicate moderate depression, scores 15-19 indicate moderately severe depression, and scores ranging from 20-27 indicate severe depression. A clinically meaningful improvement in symptoms of depression is defined as a decrease of 1.7 points on the PHQ-9.
Measured: This secondary outcome will be measured at 8 weeks.
Perceived Stress
The severity of perceived stress in participants will be assessed by the 10-item Perceived Stress Scale (PSS-10), which is a self-report scale that can be used to evaluate the severity of stress that young people and adults aged 12 and above experience in their daily life, over the past month. The survey asks the participant about feelings related to unpredictability, overwhelm, loss of control, and coping with the pace of everyday life. The survey asks the participant to describe the frequency of these feelings on a scale ranging from 0 ("never") to 4 ("very often"). Higher scores indicate higher stress; scores ranging from 0-13 indicate low stress, scores ranging from 14-26 indicate moderate stress, and scores ranging from 27-40 indicate high perceived stress. A clinically meaningful improvement in perceived stress is defined as a decrease of 11 points on the PSS-10.
Measured: This secondary outcome will be measured at 8 weeks.
Vision-Related Quality of Life
The vision-related quality of life of participants will be assessed by the 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25), which measures the dimensions of self-reported vision-targeted health status that are most important for patients who have chronic eye diseases. The survey is designed to measure the influence of visual disability and visual symptoms on emotional well-being, social functioning, and daily visual functioning. Scores range from 0-100, with higher scores representing a higher vision-related quality of life. A clinically meaningful improvement in vision-related quality of life is defined as increase of 14 points on the NEI VFQ-25.
Measured: This secondary outcome will be measured at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start26 Aug 2024
- Primary completion28 May 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-infectious UveitisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Calm.com, Inc.
- Responsible party
- Sponsor
- Investigators
- Nisha Acharya, MD, MS, Principal investigator, UCSF, Proctor Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585670
- Sponsor's protocol ID
- 23-38336
- Acronym
- MARiGOLD
- Status last verified
- Mar 2026
- First submitted
- 3 Sep 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29766596Niemeyer 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.
PubMed 31201795
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Digital Mindfulness and Meditation Intervention on Mental Health and Vision-Related Quality of Life in Adults With Non-infectious Uveitis
- ClinicalTrials.gov ID
- NCT06585670
- Acronym / sponsor ID
- MARiGOLD / 23-38336
- Conditions
- Non-infectious Uveitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Calm.com, Inc.
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Mindfulness Intervention Arm | Experimental | Other: Calm Health - smartphone applicationParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calm Health - smartphone applicationParticipants 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. | Other | Digital Mindfulness Intervention Arm |
Primary outcome
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.
3 secondary outcomes
Depression Symptoms
Time frame: This secondary outcome will be measured at 8 weeks.
Perceived Stress
Time frame: This secondary outcome will be measured at 8 weeks.
Vision-Related Quality of Life
Time frame: This secondary outcome will be measured at 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 29766596Rosen 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.
- Background: PubMed 31201795Niemeyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nisha Acharya, MD, MS principal investigator
UCSF, Proctor Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calm Health - smartphone application in people with Non-infectious Uveitis, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Symptoms (time frame: The primary outcome will be measured at 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06585670, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.