Pain and Stress Management for Fibromyalgia
Completed · Phase 2
Conditions studied: Fibromyalgia
In brief
This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.
Key facts
- Study ID
- NCT01287481
- Run by
- Wayne State University
- People needed
- 230
- Starts
- 2011-05-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2016-03-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:
- 1990 ACR criteria including tender points
- 2010 ACR modified clinical criteria that does not include tender points
You may not qualify if…
- Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
- Other serious medical conditions that can impair health status independent of FM
- Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
- Alcohol/drug dependence in past 2 years
- Cognitive impairment or dementia
- Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
- Unable to fluently read or converse in English
- Planning to move from the area in the next 14 months
- Judgment of principle investigator as not appropriate for this trial or all intervention arms
Where it is running
- University of Michigan Medical Center — Ann Arbor, Michigan, United States
- Wayne State University — Detroit, Michigan, United States
- St. John Providence Hospital — Southfield, Michigan, United States
Full record on ClinicalTrials.gov
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