Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis (DREAMER)

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Behavioral: Mindfulness Program

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
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Osher Center for Integrative Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: Mindfulness Program; 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.; Other Names: MBSR; Mindfulness-Based Stress Reduction; MBSR-RD
No Intervention: Treatment as Usual (TAU); Individuals in the TAU group will continue engaging in routine care and be asked to refrain from participating in mindfulness programs during the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. We are reporting the number and percentage of MBSR-RD participants with CSQ-8 scores ≥ 24, consistent with adequate satisfaction.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MBSR Course Attendance (Intervention Adherence)	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.	8 weeks
Percent of Study Completers (Study Retention)	Study retention will be operationalized as the number of participants who completed assessments (questionnaires and physician disease activity assessments) at the follow-up time-point divided by the number of participants who enrolled in the study, multiplied by 100.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Disease Activity Index (CDAI) Pre-Post Change From Baseline to 8 Weeks	The Clinical Disease Activity Index (CDAI) is a validated measure of Rheumatoid Arthritis (RA) disease activity recommended by the American College of Rheumatology. It sums the 28 swollen joint count (SJC; 0-28), 28 tender joint count (TJC; 0-28), patient global assessment (PGA; 0-10), and provider global assessment (PrGA; 0-10) via: SJC + TJC + PGA + PrGA. For all individual components and the total 0-76 score, higher values indicate worse disease. Thresholds are: Remission (< 2.8), Low (<=10), Moderate (10-22), and High (> 22) Disease Activity. It is used in RA clinical trials and recommended for use in routine rheumatologic care. This assessment serves as an exploratory outcome in the current trial, as the study is not powered to test efficacy. The outcome reported for this variable is the change in CDAI score from baseline to post-intervention at 8 weeks.	change from baseline to 8 weeks
DAS28-ESR Pre-Post Change From Baseline to 8 Weeks	The Disease Activity Score 28-joint Count (DAS-28) is a validated measure of Rheumatoid Arthritis (RA) disease activity frequently used in pharmaceutical trials. The Erythrocyte Sedimentation Rate (ESR) is a blood test measuring how quickly red blood cells sink in a tube; higher rates indicate more inflammation. The DAS-28 incorporates the 28 tender joint count (TJC; 0-28), 28 swollen joint count (SJC; 0-28), ESR, and patient global assessment (PGA; 0-10). It is calculated via: 0.56* √ (TJC28) + 0.28* √ (SJC28) + 0.70*ln (ESR) + 0.014* (PGA). For all components and the total 0-9.4 score, higher values indicate worse disease activity. Thresholds are: Remission (< 2.6), Low (2.6 to <= 3.2), Moderate (> 3.2 to <= 5.1), and High (> 5.1) Disease Activity. The reported outcome is the change in DAS-28 score from baseline to 8 weeks. This is an exploratory outcome as the study is not powered to assess whether MBSR-RD is effective for improving clinical outcomes.	change from baseline to 8 weeks
Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5) Pre-Post Change From Baseline to 8 Weeks	The Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5) is a validated patient-reported assessment of RA disease activity that comprises five questions on a Likert scale from 0 to 10. A higher score on the scale of 0-10 indicates worse disease activity. Remission is defined as less than 1.5, Low Disease Activity is between 1.6 and 3.0, Moderate Disease Activity is between 3.2 and 5.4, and High Disease Activity is a score greater than 5.6. We used a modified version of the Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5) in which the period of recall is 2 weeks instead of 6 months. This is an exploratory outcome measure as the current study is not adequately powered to assess whether MBSR-RD is effective for improving clinical outcomes. The reported outcome is the change in RADAI-5 score from baseline to 8 weeks.	change from baseline to 8 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, 4-Item Scale Pre-Post Change From Baseline to 8 Weeks	The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities. The scores are converted to T-scores (mean = 50, SD = 10), with higher scores indicating worse pain interference. A T-score less than or equal to 55 is described as within normal limits, between 55 to 60 is considered mild pain interference, 60 to 70 is considered moderate pain interference, and above 70 is considered severe pain interference. This is an exploratory outcome measure as the current study is not adequately powered to assess whether MBSR-RD is effective for improving clinical outcomes. The reported outcome is the change in PROMIS Pain Interference T-score from baseline to 8 weeks.	change from baseline to 8 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, 4-Item Scale Pre-Post Change From Baseline to 8 Weeks	The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale measures the experience of fatigue and associated impact on daily life. This scale is converted to a T-score (mean = 50, SD = 10), with higher scores indicating worse fatigue. A T-score less than or equal to 55 is considered within normal limits, between 55 to 60 is considered mild fatigue, 60 to 70 is considered moderate fatigue, and above 70 is considered severe fatigue. This is an exploratory outcome measure as the current study is not adequately powered to assess whether MBSR-RD is effective for improving clinical outcomes. The reported outcome is the change in PROMIS Fatigue T-score from baseline to 8 weeks.	change from baseline to 8 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mindfulness, 13-item Scale Pre-Post Change From Baseline to 8 Weeks	The Patient-Reported Outcomes Measurement Information System (PROMIS) Mindfulness scale measures the capacity for present moment awareness. This is an exploratory outcome measure that will be used in future larger trials to determine whether mindfulness mediates improvements in clinical outcomes such as pain among participants in the active treatment group. We are reporting raw scores rather than T-scores for this PROMIS measure as the PROMIS Assessment Center has not yet released the scoring algorithms required for conversion to T-scores. The range for raw scores is 13-65, with higher scores indicating higher levels of mindfulness. The reported outcome is the change in PROMIS Mindfulness score from baseline to 8 weeks.	change from baseline to 8 weeks
Perceived Stress Scale, 10-item Pre-Post Change From Baseline to 8 Weeks	Change in Perceived Stress Scale total score. Range is 0 to 40. Higher scores indicate more perceived stress. The reported outcome is the change in Perceived Stress Scale score from baseline to 8 weeks.	change from baseline to 8 weeks
Brief Resilience Scale Pre-Post Change From Baseline to 8 Weeks	The Brief Resilience Scale measures the perceived ability to bounce back or recover from psychological stress. The scale is scored from 1-5, where a higher score reflects a higher level of resilience to stress. This is an exploratory outcome measure and will be used to determine whether stress resilience mediates improvements in clinical outcomes such as pain among participants in the active treatment group. The reported outcome is the change in the Brief Resilience Scale score from baseline to 8 weeks.	change from baseline to 8 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8-item Scale Pre-Post Change From Baseline to 8 Weeks	Sleep disturbance was measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8-item short form, a validated self-report measure of sleep quality and sleep-related difficulties over the past 7 days. Scores are converted to standardized T-scores (mean = 50, SD = 10), with higher scores indicating worse sleep disturbance. A T-score less than or equal to 55 is described as within normal limits, between 55 to 60 is described as mild sleep disturbance, 60 to 70 is described as moderate sleep disturbance, and above 70 is described as severe sleep disturbance. The reported outcome is the change in PROMIS Sleep Disturbance T-score from baseline to 8 weeks.	change from baseline to 8 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression, 8-item Scale Pre-Post Change From Baseline to 8 Weeks	Depressive symptoms will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8-item short form, a validated self-report measure assessing depressive symptoms over the past 7 days. Scores are converted to standardized T-scores (mean = 50, SD = 10), with higher scores indicating worse depressive symptoms. A T-score less than or equal to 55 is described as within normal limits, between 55 to 60 is described as mild depression, 60 to 70 is described as moderate depression, and above 70 is described as severe depression. The reported outcome is the change in PROMIS Depression T-score from baseline to 8 weeks.	change from baseline to 8 weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Sarah L Patterson, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 22, 2025

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Autoimmune Diseases; Rheumatic Diseases
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Connective Tissue Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Arthritis, Rheumatoid; Rheumatic Diseases; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Stress Reduction
• Other Study ID Numbers: K23AT011768-01 (U.S. NIH Grant/Contract); K23AT011768 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No