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Web-based Education to Enhance Fibromyalgia Management

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Contents

clinicaltrials.gov/study/NCT00423631
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT004236310
Health Conditions in Trial
Fibromyalgia
Fibromyalgia
0
Trial Recruitment Size
1180
Trial Sponsor
University of Michigan
University of Michigan
0
Clinical Trial Start Date
2006
0
Primary Completion Date
2008
0
Study Completion Date
2008
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Behavioral0
Interventional Trial Phase
Not Applicable0
Official Name
Internet-Enhanced Management of Fibromyalgia0
Last Updated
October 10, 2011
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
Standard care and web0
Standard Care0
Study summary

Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered a chronic condition and is most commonly treated or managed using medications. Previous studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication intervention, to standard care in order to obtain better outcomes in terms of improved functional status and symptom reduction. While the addition of CBT to standard care has been shown to be beneficial, it is not a form of therapy that is widely available to patients with FMS. CBT includes a variety of skills that can be taught to patients to help in the management of chronic illnesses. This protocol will examine the relative merits of providing these CBT skills to patients via an informational website. The website will contain the content of CBT, a social support capability, and data transfer capabilities. The addition of this website to standard care will be compared to standard care alone. This study is interested in assessing improvements in physical functional status, the symptoms of FMS, and the relative costs of the interventions as compared to the savings in health care utilization over a 6-month period. Primary Hypothesis The primary hypothesis of this study is that the number of patients with fibromyalgia who are able to achieve clinically meaningful improvements in physical function will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website. Secondary Hypotheses 1. The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in symptoms of FMS such as pain, fatigue, and perceived cognitive difficulties will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website 2. The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in mood and beliefs about pain will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website

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