Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis (DREAMER)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Arthritis, Rheumatoid

Treatments: Behavioral: Mindfulness Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06276387

K23AT011768-01

K23AT011768 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Mindfulness Program

Experimental group

Description:

Individuals in the mindfulness group will complete an 8-week mindfulness course that has been adapted for individuals with rheumatic diseases (MBSR-RD).

Treatment:

Behavioral: Mindfulness Program

Treatment as Usual (TAU)

No Intervention group

Description:

Individuals in the TAU group will continue engaging in routine care and be asked to refrain from participating in mindfulness programs during the trial.