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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00071292
Other study ID # P50AT000084
Secondary ID Pradhan, Elizabe
Status Completed
Phase Phase 2
First received October 17, 2003
Last updated March 5, 2008
Start date July 2003
Est. completion date March 2005

Study information

Verified date March 2008
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
stress reduction program

meditation


Locations

Country Name City State
United States University of Maryland School of Medicine - Kernan Hospital Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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