Physicians at 16 rural clinics across five states – North and South Dakota, Iowa, Minnesota, and Nebraska – are recruiting Fibromyalgia patients of both sexes, ages 18 through 70, who have computer access to an Internet connection, printer, and speaker or headphones.
The controlled trial, sponsored by researchers at the University of Michigan, will seek to determine whether a greater number of patients with Fibromyalgia will be able to achieve clinically meaningful improvements in pain, fatigue, perceived cognitive difficulties, mood, and beliefs about pain when standard symptom-based pharmacological care is augmented by cognitive behavioral therapy (CBT) skills delivered through an educational website.
An Attempt to Overcome Serious FM Patient Barriers
“Despite the demonstrated effectiveness of combining pharmacological interventions with CBT,” the researchers explain, “integration of CBT into mainstream clinical practice for FMS has been slow. Barriers have not been due to lack of demonstrated efficacy, but rather to economic and administrative issues such as:
- The lack of CPT codes for applying a psychological intervention for a physical illness,
- Difficulties administering a time-intensive psychological intervention to populations that must travel long distances each week to obtain the intervention,
- And the lack of sufficient numbers of trained professionals to deliver the intervention on a large scale.
Subjects will be recruited by practicing physicians either at the main hospital in Sioux Falls, South Dakota or in any of 15 affiliated rural clinic study sites.
Criteria for Inclusion:
- 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 or older
- Have been in standard medical care with a physician for at least 3 months.
- Have a home computer or access to a computer with an Internet browser that is Internet Explorer version 5.0 or higher; a printer, and speakers or head
- Be able to use e-mail and have access to the Internet
- 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
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 (such as complete blindness)
- Co-morbid medical illnesses capable of causing a worsening of physical functional status independent of Fibromyalgia (such as morbid obesity, autoimmune diseases); cardiopulmonary disorders (such as angina, congestive heart failure, COPD, chronic asthma); uncontrolled endocrine or allergic disorders (such as thyroid dysfunction, Type I diabetes); and malignancy within 2 years.
- Any present psychiatric disorder involving a history of psychosis (such as 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.
Contacts for More Information and To Determine Clinic Locations:
Please refer to this study by ClinicalTrials.gov identifier NCT00423631
Research Staff – Phone: 605-322-3050 E-mail: firstname.lastname@example.org
- Manish Sheth, MD, PhD, Avera Research Institute, Sioux Falls, South Dakota;
- David A Williams, PhD, University of Michigan
- Health Authority: U.S. Institutional Review Board