Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases
- Conditions
- Non-infectious Uveitis
- Interventions
- Other: Calm Health - smartphone application
- Registration Number
- NCT06585670
- Lead Sponsor
- University of California, San Francisco
- 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, we 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 our patients. Overall, we aim to collect data on the value of supplementing medical care with an accessible digital mental health resource.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Digital Mindfulness Intervention Arm Calm Health - smartphone application 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.
- Primary Outcome Measures
Name Time Method Anxiety Symptoms 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 Outcome Measures
Name Time Method Depression Symptoms This secondary outcome will be measured at 8 weeks. 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.
Perceived Stress This secondary outcome will be measured at 8 weeks. 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.
Vision-Related Quality of Life This secondary outcome will be measured at 8 weeks. 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.
Trial Locations
- Locations (1)
UCSF
🇺🇸San Francisco, California, United States