Status:
COMPLETED
Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
Lead Sponsor:
Mike Hsu
Collaborating Sponsors:
St. John Providence Hospital
Blue Care Network of Michigan
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 oth...
Detailed 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 anecdotall...
Eligibility Criteria
Inclusion
- fibromyalgia, as defined by American College of Rheumatology 1990 criteria.
- at least 18 years of age.
- have access to transportation to and from Providence Hospital, Southfield, MI.
Exclusion
- co-morbid medical conditions capable of causing a worsening of physical functional status independent of FM, including morbid obesity, autoimmune diseases, cardiopulmonary disorders (e.g. angina, congestive heart failure, COPD, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), pregnancy, and malignancy within the preceding 2 years.
- any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), post-traumatic stress disorder, current suicide risk or history of suicide attempt, or substance abuse within 2 years. Note: Subjects with mood or anxiety disorders otherwise will not be excluded.
- changes in medication regimen within one month prior to enrollment.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00437411
Start Date
April 1 2007
End Date
November 1 2008
Last Update
October 24 2016
Active Locations (1)
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1
St. John Providence Hospital
Southfield, Michigan, United States, 48075