Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-03 @ 5:44 AM
Study NCT ID:
NCT00071292
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2003-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meditation-Based Stress Reduction in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2005-03'}, 'lastUpdateSubmitDate': '2008-03-05', 'studyFirstSubmitDate': '2003-10-17', 'studyFirstSubmitQcDate': '2003-10-20', 'lastUpdatePostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-21', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'stress reduction', 'meditation', 'mindfulness', 'MBSR', 'mindfulness-based stress reduction', 'mind-body skills'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '7042457', 'type': 'BACKGROUND', '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. doi: 10.1016/0163-8343(82)90026-3.'}, {'pmid': '3897551', 'type': 'BACKGROUND', 'citation': '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': '1609875', 'type': 'BACKGROUND', '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. doi: 10.1176/ajp.149.7.936.'}, {'pmid': '7649463', 'type': 'BACKGROUND', '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. doi: 10.1016/0163-8343(95)00025-m.'}, {'pmid': '8307341', 'type': 'BACKGROUND', '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. doi: 10.1016/0163-8343(93)90020-o.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Confirmed diagnosis of RA, with doctor's letter or doctors' bill with ICD code 714;\n* 18 years of age or older;\n* Able to read and write English;\n* Able to attend 15 course sessions and questionnaire sessions at Kernan Hospital in Baltimore;\n* Willing to practice skills for 45 minutes to 1 hour per day, 6 days a week;\n* Stable on rheumatoid medications for at least one month.\n\nExclusion criteria:\n\n* Major psychiatric illness (bipolar disorder, multiple personality disorder, etc.);\n* Active alcoholism or drug dependency;\n* Scheduled for major surgery during the study period;\n* Enrolled in randomized clinical trial for rheumatoid arthritis during the study period;\n* Planning to move out of the area in the next 12 months;\n* Unwilling to be enrolled in a control group;\n* Use of assistive device other than a cane;\n* Serious health condition(s) that the investigator determines would make it difficult to complete the 6 month study;\n* Diagnosis of fibromyalgia."}, 'identificationModule': {'nctId': 'NCT00071292', 'briefTitle': 'Meditation-Based Stress Reduction in Rheumatoid Arthritis', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Mindfulness Meditation-Based Stress Reduction in Relieving Symptoms Associated With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'P50AT000084', 'link': 'https://reporter.nih.gov/quickSearch/P50AT000084', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'Pradhan, Elizabeth'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'stress reduction program', 'type': 'BEHAVIORAL'}, {'name': 'meditation', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21207', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Medicine - Kernan Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Brian Berman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, Center for Integrative Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}