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Behavioral Intervention

Mindfulness Program for Rheumatoid Arthritis (DREAMER Trial)

N/A

Recruiting

Led By Sarah Patterson, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physician-confirmed diagnosis of rheumatoid arthritis (RA)

Be older than 18 years old

Must not have

RA disease activity in remission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The goals are to assess patient satisfaction, identify barriers to participation, and understand how mindfulness impacts RA symptoms. Participants will

Who is the study for?

This trial is for individuals with an active rheumatoid arthritis diagnosis who can access the internet via a computer or mobile device. It's not suitable for those in RA remission, already practicing mindfulness regularly, unable to commit to an 8-week course, or have completed a similar MBSR course before.

What is being tested?

The study tests a mindfulness program against standard care in people with rheumatoid arthritis. Participants will fill out questionnaires, undergo exams and blood draws, and may join an online mindfulness course or focus group to evaluate satisfaction and barriers.

What are the potential side effects?

Since this trial involves a non-medical intervention (mindfulness), typical drug side effects are not expected. However, participants might experience emotional discomfort or increased awareness of stress during the practice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My doctor has diagnosed me with rheumatoid arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My rheumatoid arthritis is currently in remission.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study

Secondary study objectives

MBSR Course Attendance (Intervention Adherence)

Percent of Study Completers (Study Retention)

Other study objectives

Brief Resilience Scale

Clinical Disease Activity Index (CDAI)

Disease Activity Score in 28 Joints (DAS-28)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness ProgramExperimental Treatment1 Intervention

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

Group II: Treatment as Usual (TAU)Active Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness Program

2016

N/A

~110

0 / 2Eligibility criteria met