Arthritis, Rheumatoid
Conditions
Keywords
Mindfulness, Rheumatic Diseases, Autoimmune Diseases
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.
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.
Interventions
BEHAVIORALMindfulness 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.
Sponsors
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MBSR Course Attendance (Intervention Adherence) | 8 weeks | 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. |
| Percent of Study Completers (Study Retention) | 8 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah L Patterson, MD
University of California, San Francisco
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.61 years STANDARD_DEVIATION 13.69 |
| Annual household income $100,000 or more | 7 Participants |
| Annual household income $40,000 or more and less than $60,000 | 1 Participants |
| Annual household income $60,000 or more and less than $80,000 | 2 Participants |
| Annual household income $80,000 or more and less than $100,000 | 1 Participants |
| Annual household income Decline to Answer | 11 Participants |
| Annual household income Less than $20,000 | 4 Participants |
| Anti-CCP positive No | 8 Participants |
| Anti-CCP positive Yes | 11 Participants |
| Clinical Disease Activity Index (CDAI) | 18.56 score on a scale STANDARD_DEVIATION 9.55 |
| Current cigarette smoker No | 18 Participants |
| Current cigarette smoker Yes | 0 Participants |
| Education (highest level completed) Associate's degree or trade/vocational school | 3 Participants |
| Education (highest level completed) Bachelor's degree | 2 Participants |
| Education (highest level completed) Less than high school | 1 Participants |
| Education (highest level completed) Master's, PhD, or professional degree | 18 Participants |
| Education (highest level completed) Some college but no degree | 8 Participants |
| Employment status Decline to Answer | 0 Participants |
| Employment status Going to school | 0 Participants |
| Employment status In school; Working | 1 Participants |
| Employment status Looking for work | 1 Participants |
| Employment status Other (describe) | 1 Participants |
| Employment status Retired | 8 Participants |
| Employment status Retired; Volunteering | 0 Participants |
| Employment status Unable to work | 5 Participants |
| Employment status Unable to work; Retired | 1 Participants |
| Employment status Working | 8 Participants |
| Marital Status Divorced or separated | 3 Participants |
| Marital Status Married or living with a partner | 14 Participants |
| Marital Status Never married | 4 Participants |
| Marital Status Widowed | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants |
| Race/Ethnicity, Customized Race Black | 7 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 2 Participants |
| Race/Ethnicity, Customized Race More than one race | 1 Participants |
| Race/Ethnicity, Customized Race White | 9 Participants |
| Rheumatoid factor positive No | 8 Participants |
| Rheumatoid factor positive Yes | 11 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 1 Participants |
| Smoked >= 100 Cigarettes in Lifetime No | 12 Participants |
| Smoked >= 100 Cigarettes in Lifetime Yes | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
None listed