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Clinical Trial Summary

The investigators are studying whether a brief three-session mind-body workshop helps people with fibromyalgia. The investigators hypothesize that this workshop will significantly improve pain and other symptoms, compared to usual care.


Clinical Trial Description

The affective self-awareness approach presumes that many chronic pain states, such as fibromyalgia (FM), can be effectively treated by encouraging self-awareness of emotional tension. While anecdotally effective in selected patients, this approach has thus far not been tested in a randomized controlled trial. Our purpose is to determine whether an affective self-awareness approach significantly improves pain, tenderness, and other FM symptoms in a random sample of FM patients; and to determine what psychosocial factors predict a favorable response.

Comparisons: changes in ratings of pain, tenderness, and other symptoms between two arms of the study:

- three weekly 2-hour small-group meetings supplemented with daily writing and meditative exercises to enhance affective self-awareness

- usual care ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00437411
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase N/A
Start date April 2007
Completion date November 2008

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