Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

— DREAMER  

Official title:

Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276387
• Other study ID #: K23AT011768-01
• Secondary ID: K23AT011768
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: Sarah Patterson, MD
• Phone: 510-219-2639
• Email: sarah.patterson[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

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.

Locations

Country	Name	City	State
United States	Osher Center for Integrative Health	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Disease Activity Index (CDAI)	The CDAI, is a patient and provider composite tool that incorporates data from the patient global assessment, provider global assessment, 28 swollen joint count, and 28 tender joint count. It is a validated measure of RA disease activity that is recommended by the American College of Rheumatology for use in clinical practice and RA pharmaceutical trials. 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.	8 weeks
Other	Disease Activity Score in 28 Joints (DAS-28)	The DAS-28 is a validated measure of disease activity that is frequently employed in RA pharmaceutical clinical trials. It incorporates data from the patient global assessment, provider global assessment, 28 swollen joint count, 28 tender joint count, and a laboratory measure of systemic inflammation from either the erythrocyte sedimentation rate (ESR) or c-reactive protein (CRP). 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.	change from baseline to 8 weeks
Other	Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5)	The RADAI-5 is a validated patient-reported assessment of RA disease activity that comprises five questions in a Likert format from 0 to 10. We will use a modified version of the 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.	change from baseline to 8 weeks
Other	Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, 4-Item Scale	The PROMIS Pain Interference scale measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities. 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.	change from baseline to 8 weeks
Other	Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, 4-Item Scale	The PROMIS Fatigue scale measures the experience of fatigue and associated impact on daily life. 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.	change from baseline to 8 weeks
Other	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mindfulness, 13-item Scale	The PROMIS Mindfulness scale measures the capacity for present moment awareness. This is an exploratory outcome measure and will be used to determine whether mindfulness mediates improvements in clinical outcomes such as pain among participant in the active treatment group.	change from baseline to 8 weeks
Other	Perceived Stress Scale, 10-item	The perceived stress scale measures general perceptions of the degree to which situations in one's life are viewed as stressful. This is an exploratory outcome measure and will be used to determine whether changes in perceived stress mediate improvements in clinical outcomes such as pain among participant in the active treatment group.	change from baseline to 8 weeks
Other	Brief Resilience Scale	The Brief Resilience Scale measures the perceived ability to bounce back or recover from 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 participant in the active treatment group.	change from baseline to 8 weeks
Primary	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	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
Secondary	Percent of Study Completers (Study Retention)	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.	8 weeks