Arthritis, RheumatoidDREAMERNCT06276387
Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis
A study testing Mindfulness Program in people with Arthritis, Rheumatoid, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Mindfulness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to 22 Jan 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician-confirmed diagnosis of rheumatoid arthritis (RA)
- Access to a web-enabled computer, smartphone, or tablet
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Osher Center for Integrative Health
San Francisco, California, 94115
About this study
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
Read more
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.
Read the 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Mindfulness Program
- Keywords
- Mindfulness, Rheumatic Diseases, Autoimmune Diseases
- Medical subject headings
- Arthritis, Rheumatoid, Rheumatic Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness ProgramBehavioural
Also called Mindfulness-Based Stress Reduction, MBSR, MBSR-RD
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start26 Jan 2024
- Primary completion1 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Sarah L Patterson, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276387
- Sponsor's protocol ID
- K23AT011768-01
- Other IDs
- K23AT011768
- Acronym
- DREAMER
- Status last verified
- Apr 2026
- First submitted
- 16 Feb 2024
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No