Clinical trial NCT06276387: Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis
Official title: Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Keywords: Mindfulness
Rheumatic Diseases
Autoimmune Diseases
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-02-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study
timeFrame: 8 weeks
Secondary outcomes:
measure: MBSR Course Attendance (Intervention Adherence)
timeFrame: 8 weeks
measure: Percent of Study Completers (Study Retention)
timeFrame: 8 weeks
Other outcomes:
measure: Clinical Disease Activity Index (CDAI)
timeFrame: 8 weeks
measure: Disease Activity Score in 28 Joints (DAS-28)
timeFrame: change from baseline to 8 weeks
measure: Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5)
timeFrame: change from baseline to 8 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, 4-Item Scale
timeFrame: change from baseline to 8 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, 4-Item Scale
timeFrame: change from baseline to 8 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mindfulness, 13-item Scale
timeFrame: change from baseline to 8 weeks
measure: Perceived Stress Scale, 10-item
timeFrame: change from baseline to 8 weeks
measure: Brief Resilience Scale
timeFrame: change from baseline to 8 weeks
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Health
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sarah L Patterson, MD
role: PRINCIPAL_INVESTIGATOR
References: