- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00071292
Meditation-Based Stress Reduction in Rheumatoid Arthritis
March 5, 2008 updated by: National Center for Complementary and Integrative Health (NCCIH)
Mindfulness Meditation-Based Stress Reduction in Relieving Symptoms Associated With Rheumatoid Arthritis
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21207
- University of Maryland School of Medicine - Kernan Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Brian Berman, MD, Director, Center for Integrative Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.
- Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med. 1985 Jun;8(2):163-90. doi: 10.1007/BF00845519.
- Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936.
- Miller JJ, Fletcher K, Kabat-Zinn J. Three-year follow-up and clinical implications of a mindfulness meditation-based stress reduction intervention in the treatment of anxiety disorders. Gen Hosp Psychiatry. 1995 May;17(3):192-200. doi: 10.1016/0163-8343(95)00025-m.
- Kaplan KH, Goldenberg DL, Galvin-Nadeau M. The impact of a meditation-based stress reduction program on fibromyalgia. Gen Hosp Psychiatry. 1993 Sep;15(5):284-9. doi: 10.1016/0163-8343(93)90020-o.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Study Completion
March 1, 2005
Study Registration Dates
First Submitted
October 17, 2003
First Submitted That Met QC Criteria
October 20, 2003
First Posted (ESTIMATE)
October 21, 2003
Study Record Updates
Last Update Posted (ESTIMATE)
March 7, 2008
Last Update Submitted That Met QC Criteria
March 5, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P50AT000084 (NIH)
- Pradhan, Elizabeth
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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