Fibromyalgia Clinical Trial
— (FIBCOG)Official title:
Randomized Clinical Trial of Cognitive Behavioral Therapy in Women With the Fibromyalgia Disorder
Verified date | October 2009 |
Source | Uppsala University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Swedish Research Council |
Study type | Interventional |
Previous studies have shown that the disorder fibromyalgia often is preceded by long-term
stress. Moreover, an association has been shown between stress, pain and co-morbidity in
these patients. Cognitive behavioral therapy (CBT) has been shown effective in reducing
stress, anxiety and pain in rheumatoid arthritis and fibromyalgia. The purpose of the
present trial was to assess whether CBT may reduce pain and other symptoms and increase
well-being and general function, affect biological markers for pain and long-term stress, to
a larger extent than treatment "as usual".
Forty eight women with verified fibromyalgia were randomly allocated to an early treatment
group or a waiting list group. The early treatment group received CBT group treatment during
six months. Measurements of outcome and potential outcome affecting variables were made at
baseline, after six months and one year after baseline. The waiting list group received the
same CBT treatment as the early treatment group after six months on the waiting list.
The design is thus a traditional "waiting list design", allowing a two parallel group
comparison during the first six months and a "before-after" analysis in both groups when the
treatment was concluded.
Status | Completed |
Enrollment | 48 |
Est. completion date | December 2008 |
Est. primary completion date | December 2003 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Fibromyalgia according to the American College of Rheumatology criteria - Women - Age 18-65 - Living in Östhammar municipality, Sweden - Swedish speaking Exclusion Criteria: - severe mental disease - drug or alcohol abuse |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Dept of Public Health and Caring Sciences, Family Medicin and Clinical Epidemiology Section | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Uppsala University | National Social Insurance Board, Sweden, Reumatikerförbundet, The Swedish Society of Medicine, Uppsala County Council, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Multidimensional Pain Inventory (MPI) score | At baseline and at 6 and 12 months after baseline | No | |
Secondary | Type A behavior measures | At baseline and at 6 and 12 months after baseline | No |
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