Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis (NCT06276387) | Clinical Trial Compass
CompletedNot Applicable
Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis
United States38 participantsStarted 2024-01-26
Plain-language summary
This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to:
* Assess patient satisfaction with a mindfulness course
* Identify barriers to participation in, or completion of, a mindfulness course
* Gather initial information to understand how a mindfulness course impacts RA symptoms
Participants will:
* Complete online questionnaires
* Attend two in-person study visits, involving a brief joint exam and blood draw
* Roughly half the participants will have the chance to participate in an 8-week online mindfulness course
* Roughly half the participants will be invited to participate in an online focus group following completion of the mindfulness course
Researchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with RA.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Physician-confirmed diagnosis of rheumatoid arthritis (RA)
* Access to a web-enabled computer, smartphone, or tablet
Exclusion Criteria:
* RA disease activity in remission
* Current regular mindfulness practice (\> 20 minutes per week)
* Inability to participate in an intensive 8-week online mindfulness course
* Prior participation in a mindfulness-based stress reduction (MBSR) course
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study