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Sponsored by: |
University of Michigan |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00423631 |
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
Condition | Intervention |
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Fibromyalgia Fibrositis |
Behavioral: Cognitive-behavioral therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Internet-Enhanced Management of Fibromyalgia |
Estimated Enrollment: | 170 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | June 2008 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
SUBJECTS WILL NEED TO COME TO SIOUX FALLS FOR THE STUDY VISITS.
The study sample will be drawn from a population of individuals diagnosed with fibromyalgia in a five state region consisting of North and South Dakota, Iowa, Minnesota, and Nebraska.
Subjects will be recruited into the study by practicing physicians either at the main hospital in Sioux Falls or in any of 15 affiliated rural clinic study sites. In order to be included in the study, potential subjects must meet the study inclusion and exclusion criteria.
Inclusion Criteria:
Subjects must have a home computer or access to a computer with the following features:
Subjects must be able to perform the following screening test designed to assess computer ability:
Exclusion Criteria:
Subjects will be excluded from participation if they have any of the following:
United States, South Dakota | |
Avera Research Institute | |
Sioux Falls, South Dakota, United States, 57105 |
Principal Investigator: | David A Williams, PhD | University of Michigan |
Study ID Numbers: | DAMD 17-002-0018, A-9356.1 |
Study First Received: | January 17, 2007 |
Last Updated: | December 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00423631 |
Health Authority: | United States: Institutional Review Board |
Pain Fibromyalgia Internet |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases |
Nervous System Diseases |