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Internet-Enhanced Management of Fibromyalgia

Principal Investigator: David Williams, PhD
Co-Principal Investigator: Daniel Clauw, MD
Avera McKennan Site Principal Investigator: David Kuper, RPh, MS
Study Physician: Manish Sheth, MD
Study Coordinator: Susan Weaver, CNP
Study Liaison: Kimberly Groner, MSN, RN, CANP
Medical Monitor: Donald T. Bishop, MD
Target Condition: Fibromyalgia

Overview

Fibromyalgia (FMS), a condition marked by pain, fatigue, and memory complaints, is considered a chronic condition, and is most commonly treated or managed using symptom-based pharmacological interventions.

Previous studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-pharmacological intervention, to standard pharmacological 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. This protocol will examine the relative merits of adding CBT to standard care in an experimental format.

The experimental format uses an informational website. The website will contain the content of CBT, a social support capability, and data transfer capabilities.

The experimental CBT format will be compared to standard care alone. The researchers are 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 healthcare utilization over a 12-month period.

Basic Inclusion and Exclusion Criteria

Inclusion Criteria

All patients must fulfill the diagnostic criteria for fibromyalgia as established by the American College of Rheumatology (ACR) in 1990 (Wolfe et al., 1993)

All patients must be 18 years of age or older

All patients must be in standard medical care with their primary care physician for at least 3 months

All patients must have a home computer or access to a computer with the following features:

  • Netscape or Internet Explorer, version 4.0 or greater
  • A printer
  • Ability to use email, and daily access to the internet

Subjects must be able to complete the following screening test for computer ability: Go to a webpage, log on to a website, click on an icon, click on a radio button to answer a multiple choice question, type a name into a text box, click on a submit button, and print a document.

Exclusion Criteria

Subjects will be excluded from participation if they have any of the following:

  • A severe physical impairment that precludes receiving cognitive behavioral therapy (e.g. complete blindness or deafness).
  • 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 disfunction, 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. Note: Subjects with mood disorders will not be excluded.
  • Prior CBT for pain management

If you wish to participate or would like more information, please contact the Avera Research Institute at (605) 322-3050 or toll-free at (888) 634-7268.