Clinical Trial Finder

Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06276387
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of California, San Francisco
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Sarah Patterson, MD
Principal Investigator Affiliation University of California, San Francisco
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Arthritis, Rheumatoid
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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).

No Intervention: 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.

Interventions

Behavioral: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Osher Center for Integrative Health, San Francisco, California

Status

Recruiting

Address

Osher Center for Integrative Health

San Francisco, California, 94115

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