Meditation-Based Stress Reduction in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00071292
First received: October 17, 2003
Last updated: March 5, 2008
Last verified: March 2008
  Purpose

The purpose of this study is to determine whether a mindfulness meditation-based stress reduction program is useful in relieving symptoms associated with rheumatoid arthritis (RA).


Condition Intervention Phase
Rheumatoid Arthritis
Behavioral: stress reduction program
Behavioral: meditation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Mindfulness Meditation-Based Stress Reduction in Relieving Symptoms Associated With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 80
Study Start Date: July 2003
Estimated Study Completion Date: March 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Confirmed diagnosis of RA, with doctor's letter or doctors' bill with ICD code 714;
  • 18 years of age or older;
  • Able to read and write English;
  • Able to attend 15 course sessions and questionnaire sessions at Kernan Hospital in Baltimore;
  • Willing to practice skills for 45 minutes to 1 hour per day, 6 days a week;
  • Stable on rheumatoid medications for at least one month.

Exclusion criteria:

  • Major psychiatric illness (bipolar disorder, multiple personality disorder, etc.);
  • Active alcoholism or drug dependency;
  • Scheduled for major surgery during the study period;
  • Enrolled in randomized clinical trial for rheumatoid arthritis during the study period;
  • Planning to move out of the area in the next 12 months;
  • Unwilling to be enrolled in a control group;
  • Use of assistive device other than a cane;
  • Serious health condition(s) that the investigator determines would make it difficult to complete the 6 month study;
  • Diagnosis of fibromyalgia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071292

Locations
United States, Maryland
University of Maryland School of Medicine - Kernan Hospital
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
Investigators
Principal Investigator: Brian Berman, MD Director, Center for Integrative Medicine
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00071292     History of Changes
Other Study ID Numbers: P50 AT000084, Pradhan, Elizabeth
Study First Received: October 17, 2003
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
rheumatoid arthritis
stress reduction
meditation
mindfulness
MBSR
mindfulness-based stress reduction
mind-body skills

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014