NCT00071292

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

March 7, 2008

Status Verified

March 1, 2008

First QC Date

October 17, 2003

Last Update Submit

March 5, 2008

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisstress reductionmeditationmindfulnessMBSRmindfulness-based stress reductionmind-body skills

Interventions

stress reduction programBEHAVIORAL
meditationBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of RA, with doctor's letter or doctors' bill with ICD code 714;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Medicine - Kernan Hospital

Baltimore, Maryland, 21207, United States

Location

Related Publications (5)

  • 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.

    PMID: 7042457BACKGROUND

  • 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.

    PMID: 3897551BACKGROUND

  • 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.

    PMID: 1609875BACKGROUND

  • 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.

    PMID: 7649463BACKGROUND

  • 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.

    PMID: 8307341BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Meditation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Brian Berman, MD

    Director, Center for Integrative Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

October 17, 2003

First Posted

October 21, 2003

Study Start

July 1, 2003

Study Completion

March 1, 2005

Last Updated

March 7, 2008

Record last verified: 2008-03

Locations

US(1)