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NCT06276387 | RECRUITING | Arthritis, Rheumatoid


Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis
Sponsor:

University of California, San Francisco

Brief 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.

Condition or disease

Arthritis, Rheumatoid

Intervention/treatment

Mindfulness Program

Phase

NA

Detailed Description:

Participants will complete an initial eligibility screening, and if they are eligible, they will meet with a study staff member to review study procedures and answer any questions they might have about participating. If they would like to participate following this meeting, they will provide written consent and be enrolled in the study. Following enrollment, participants will complete an in-person study visit that will last up to one hour and include a brief joint exam, blood draw, and questionnaires. After this study visit, they will be randomly assigned to "treatment-as-usual" (TAU) or the mindfulness group. If assigned to the mindfulness group, they will participate in an 8-week online mindfulness course and online focus group following the course. All participants will complete a final in-person study visit at the end of the study, which will mimic the procedures of the first study visit.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : DOUBLE
Masking Description : Physicians completing joint exams to assess clinical disease activity, including the principal investigator, will be blinded to participant assignment. It will not be possible for participants to be blinded to treatment condition.
Primary Purpose : OTHER
Official Title : Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis
Actual Study Start Date : 2024-01-26
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis

Location Details

NCT06276387


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How to Participate

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Locations


RECRUITING

United States, California

Osher Center for Integrative Health

San Francisco, California, United States, 94115

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