Meditation-Based Stress Reduction in Rheumatoid Arthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 17, 2003

Last Updated Date

March 5, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00071292 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Meditation-Based Stress Reduction in Rheumatoid Arthritis

Official Title ^ICMJE

Mindfulness Meditation-Based Stress Reduction in Relieving Symptoms Associated With Rheumatoid Arthritis

Brief Summary

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).

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Behavioral: stress reduction program
Behavioral: meditation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00071292

Responsible Party

Study ID Numbers ^ICMJE

P50 AT000084, Pradhan, Elizabeth

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Brian Berman, MD

Director, Center for Integrative Medicine

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP