Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
The goal of this proposal is to evaluate the efficacy of a multiple component mind-body (MCMB) therapy for fibromyalgia, both in short and long term outcomes. Preliminary work suggests that FM patients do benefit from MCMB therapy (Singh et al 1998; Creamer et al 1998). This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB intervention or a 12 week education/attention intervention. The primary aims of this study are 1) to determine if a 12 week MCMB intervention improves short term (i.e. at 12 weeks) outcomes in FM patients compared to an education/attention control group; and 2) to determine if a 12 week MCMB intervention improves long term (i.e. at 24 weeks) outcomes in FM patients compared to an education/attention control group. A secondary aim of this project involves determining if there are patient characteristics (i.e. disease severity and duration, demographics, psychological factors) associated with improvements in short or long term outcomes as well as responses to the MCMB intervention. The primary outcome measure will include physical functioning and pain as measured by the Fibromyalgia Impact Questionnaire.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 1999
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1999
CompletedFirst Submitted
Initial submission to the registry
February 2, 2001
CompletedFirst Posted
Study publicly available on registry
February 5, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedAugust 18, 2006
August 1, 2006
February 2, 2001
August 17, 2006
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of fibromyalgia by patient's own health care provider
- ACT classification of fibromyalgia verified by rheumatological examination: a) widespread pain (axial plus upper and lower segment plus left-and-right-sided pain for 3 months or longer; b) tenderness at 11 or more of the 18 specific tender point sites
- Read and speak English fluently
- Be able to attend group intervention session if assigned to that group
- Able to give informed consent
You may not qualify if:
- Pregnancy
- Substance abuse
- Major psychiatric disorder (that would prevent compliance)
- Involvement in impending litigation or judgment for disability workmen's compensation
- Uncontrolled hypertension, uncontrolled diabetes, congestive heart failure or other severe chronic medical conditions judged by the clinician to place the patient at risk of possible severe consequences of their disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Astin JA, Berman BM, Bausell B, Lee WL, Hochberg M, Forys KL. The efficacy of mindfulness meditation plus Qigong movement therapy in the treatment of fibromyalgia: a randomized controlled trial. J Rheumatol. 2003 Oct;30(10):2257-62.
PMID: 14528526BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Brian Berman
Univ. of Maryland/Complementary Medicine Program
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 2, 2001
First Posted
February 5, 2001
Study Start
September 1, 1999
Study Completion
March 1, 2004
Last Updated
August 18, 2006
Record last verified: 2006-08