Status:
COMPLETED
Web-based Education to Enhance Fibromyalgia Management
Lead Sponsor:
University of Michigan
Conditions:
Fibromyalgia
Fibrositis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ...
Detailed Description
Cognitive-Behavioral Therapy is a therapeutic approach that uses specific techniques to produce behavioral and cognitive change. CBT is not a singular approach to all problems; rather it is a set of t...
Eligibility Criteria
Inclusion
- 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.
- Ability to travel to Sioux Falls, SD for study visits.
- All subjects must fulfill the diagnostic criteria for fibromyalgia as established by the American College of Rheumatology (ACR) in 1990 (Wolfe et al., 1990)
- Be 18 years of age
- All subjects must have been in standard medical care with a physician for at least 3 months.
- Subjects must have a home computer or access to a computer with the following features:
- An Internet browser that is Internet Explorer version 5.0 or higher.
- Printer
- Speakers or headphones
- Ability to use e-mail and access to the Internet
- Subjects must be able to perform the following screening test designed to assess computer ability:
- Go to a webpage Log in to a website
- Click on an icon
- Click on a radio button to answer a multiple choice question
- Fill a name into a text box
- Click on a submit button
- Print a document
Exclusion
- Subjects will be excluded from participation if they have any of the following:
- A severe physical impairment that precludes receiving/using the website or using the CBT skills contained on the website (e.g. complete blindness)
- Co-morbid medical illnesses capable of causing a worsening of physical functional status independent of fibromyalgia (e.g. 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), and malignancy within 2 years.
- Any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), current suicide risk or attempt within 2 years of the study, or substance abuse within 2 years. Note: Subjects with mood disorders will not be excluded.
- Prior face to face CBT for pain management.
- Receiving or applying for or considering seeking disability payments.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00423631
Start Date
September 1 2006
End Date
April 1 2008
Last Update
October 10 2011
Active Locations (1)
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1
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105