Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis

NCT ID: NCT06276387

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2025-01-22

Brief Summary

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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

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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

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Mindfulness Program

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

Group Type EXPERIMENTAL

Mindfulness Program

Intervention Type BEHAVIORAL

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.

Treatment as Usual (TAU)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mindfulness-Based Stress Reduction MBSR MBSR-RD

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah L Patterson, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Osher Center for Integrative Health

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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K23AT011768

Identifier Type: NIH

Identifier Source: secondary_id

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K23AT011768-01

Identifier Type: NIH

Identifier Source: org_study_id

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