Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases
NCT Number: NCT06585670
Acronym: MARiGOLD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-infectious Uveitis
Interventions: OTHER: Calm Health - smartphone application
Sponsor: University of California, San Francisco
Collaborators: Calm.com, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2025-08
Locations: UCSF, San Francisco, California, 94158, United States

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.

Primary Outcome Measures: 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 (\&amp;#34;not at all\&amp;#34;) to 3 (\&amp;#34;nearly every day\&amp;#34;) 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. A clinically meaningful improvement in anxiety symptoms is defined as a decrease of 1.5 points on the GAD-7., The primary outcome will be measured at 8 weeks.
Secondary Outcome Measures: 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., 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., 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., This secondary outcome will be measured at 8 weeks.