Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Behavioral: Mindfulness Program

• Registration Number: NCT06276387
• Lead 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.

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 Timeline

• Study Start: 2024-01-26
• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-16
• Study First Posted: 2024-02-26
• Status Verified: 2025-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-22
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Program	Mindfulness Program	Individuals in the mindfulness group will complete an 8-week mindfulness course that has been adapted for individuals with rheumatic diseases (MBSR-RD).

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study	8 weeks	A modified version of the 8-item Client Satisfaction Questionnaire (CSQ-8) will be used to evaluate acceptability of the mindfulness program by patients in the treatment group. A few of the words in the original CSQ-8 were changed to make the questions relevant to the mindfulness program. Scores on the CSQ-8 range from 8-32, with higher scores indicating greater satisfaction. Scores ≥ 24 indicate adequate satisfaction.

Secondary Outcome Measures

Name	Time	Method
MBSR Course Attendance (Intervention Adherence)	8 weeks	Intervention adherence will be operationalized as the percentage of participants who were randomized to the mindfulness group and attended at least six of the eight group sessions.
Percent of Study Completers (Study Retention)	8 weeks	Study retention will be operationalized as the number of participants who completed assessments (questionnaires and physician disease activity assessment) at the follow-up time-point divided by the number of participants who enrolled in the study, multiplied by 100.

Trial Locations

Locations (1)

Osher Center for Integrative Health; 🇺🇸 San Francisco, California, United States