Web-based Education to Enhance Fibromyalgia Management

Completed · Not applicable

Conditions studied: Fibromyalgia, Fibrositis

In brief

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

Key facts

Study ID

NCT00423631

Run by

University of Michigan

People needed

118

Starts

2006-09-01

Expected to finish

2008-04-01

Last updated by the study team

2011-10-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Avera Research Institute — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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