Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis

NCT06276387 | Completed

• 2 other identifiers: K23AT011768-01K23AT011768
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid

Keywords

Mindfulness; Rheumatic Diseases; Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study

  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.

  8 weeks

Secondary Outcomes (2)

• MBSR Course Attendance (Intervention Adherence)

  8 weeks

• Percent of Study Completers (Study Retention)

  8 weeks

Other Outcomes (8)

• Clinical Disease Activity Index (CDAI)

  8 weeks

• Disease Activity Score in 28 Joints (DAS-28)

  change from baseline to 8 weeks

• Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5)

  change from baseline to 8 weeks

Study Arms (2)

Mindfulness Program

EXPERIMENTAL

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

Behavioral: Mindfulness Program

Treatment as Usual (TAU)

NO INTERVENTION

Individuals in the TAU group will continue engaging in routine care and be asked to refrain from participating in mindfulness programs during the trial.

Interventions

Mindfulness Program BEHAVIORAL

Participants will receive eight weekly 2.5-hour group sessions and one day-long silent retreat, delivered online. Intervention content will include the MBSR program, which has been extensively studied with many different chronic conditions, and augmentations for individuals with rheumatic diseases. Each MBSR session will include meditation practices (e.g., sitting meditation, body scan, gentle hatha yoga, walking meditation, mindfulness of daily activities, awareness of pleasant and unpleasant events) and review of home practice. Participants will complete daily home practices for about 45 minutes per day and log their practice.

Also known as: Mindfulness-Based Stress Reduction, MBSR, MBSR-RD

Mindfulness Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician-confirmed diagnosis of rheumatoid arthritis (RA)
• Access to a web-enabled computer, smartphone, or tablet

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Osher Center for Integrative Health

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Rheumatic Diseases; Autoimmune Diseases

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sarah L Patterson, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 26, 2024
• Study Start: January 26, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 22, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)