protocolSection identificationModule nctId: NCT06276387, orgStudyIdInfo id: K23AT011768-01, type: NIH, link: https://reporter.nih.gov/quickSearch/K23AT011768-01, secondaryIdInfos id: K23AT011768, type: NIH, link: https://reporter.nih.gov/quickSearch/K23AT011768, briefTitle: Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis, acronym: DREAMER, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: National Center for Complementary and Integrative Health (NCCIH), descriptionModule briefSummary: 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 symptomsParticipants 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 courseResearchers 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., conditionsModule conditions: Arthritis, Rheumatoid, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to participate in a mindfulness-based stress reduction (MBSR) course or treatment as usual (TAU). Randomization will be done using a program-tracking system., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: 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., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness Program, outcomesModule primaryOutcomes measure: Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study, secondaryOutcomes measure: MBSR Course Attendance (Intervention Adherence), secondaryOutcomes measure: Percent of Study Completers (Study Retention), otherOutcomes measure: Clinical Disease Activity Index (CDAI), otherOutcomes measure: Disease Activity Score in 28 Joints (DAS-28), otherOutcomes measure: Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5), otherOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, 4-Item Scale, otherOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, 4-Item Scale, otherOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mindfulness, 13-item Scale, otherOutcomes measure: Perceived Stress Scale, 10-item, otherOutcomes measure: Brief Resilience Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Osher Center for Integrative Health, status: RECRUITING, city: San Francisco, state: California, zip: 94115, country: United States, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False