Meditation-Based Stress Reduction in Rheumatoid Arthritis - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00071292

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 II

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:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

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

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

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Brian Berman, MD

Director, Center for Integrative Medicine

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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.

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.

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.

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.

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.

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 February 09, 2012