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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06276387
- Acronym / sponsor ID
- DREAMER / K23AT011768-01
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Mindfulness, Rheumatic Diseases, Autoimmune Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Program | Experimental | Behavioral: Mindfulness ProgramIndividuals in the mindfulness group will complete an 8-week mindfulness course that has been adapted for individuals with rheumatic diseases (MBSR-RD). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physician-confirmed diagnosis of rheumatoid arthritis (RA)
- Access to a web-enabled computer, smartphone, or tablet
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness ProgramAlso: Mindfulness-Based Stress Reduction, MBSR, MBSR-RDParticipants 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. | Behavioural | Mindfulness Program |
Primary outcome
Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study
Time frame: 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. We are reporting the number and percentage of MBSR-RD participants with CSQ-8 scores ≥ 24, consistent with adequate satisfaction.
2 secondary outcomes
MBSR Course Attendance (Intervention Adherence)
Time frame: 8 weeks
Percent of Study Completers (Study Retention)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah L Patterson, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Program in people with Arthritis, Rheumatoid, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.