Web-based Education to Enhance Fibromyalgia Management
Condition: Fibromyalgia; Fibrositis
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

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 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
    

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 techniques that can be tailored for specific problems. The techniques
      falling under the rubric of CBT have in common a scientific foundation based in learning and
      cognitive principles. The techniques used to change behavior are based on principles of
      classical and operant conditioning (e.g. extinction, positive and negative reinforcement,
      shaping, prompts), and observational learning. The techniques used to produce cognitive
      change are based largely on the development of problem solving skills and principles of
      attributional change (Craighead, Craighead, Kazdin, & Mahoney, 1994).

      Cognitive behavioral therapy has been shown to be effective in the management of symptoms for
      a wide range of chronic medical illnesses (Compas, Haaga, Keefe, Leitenberg, & Williams,
      1998; Emmelkamp & van Oppen, 1993; Gil et al., 1996)(1994; Emmelkamp et al., 1993; Turner &
      Romano, 1990; Gil et al., 1996; Keefe, 1996) including Fibromyalgia (Bradley, 1989; Nielson,
      Walker, & McCain, 1992; White & Nielson, 1995; Goldenberg, Kaplan, & Nadeau, 1994; Nielson et
      al., 1992; White et al., 1995; Goldenberg et al., 1994) and related conditions such as
      chronic fatigue syndrome (Sharpe et al., 1996; Deale, Chalder, Marks, & Wessely, 1997; Deale,
      Chalder, Marks, & Wessely, 1997). The rationale for using CBT with FMS stems from the
      assumption that pain and suffering is the result of a complex integration of pathophysiology,
      cognition, affect, and behavior (Keefe, 1996). Modification of any one of these four factors
      can positively or negatively impact the course of the persistent medical condition.

      When applied to patients having fibromyalgia, CBT has been shown to be associated with both
      short-term (3 weeks) and long-term (30 months) improvements in pain, distress, and perceived
      control over pain (Nielson et al., 1992; White et al., 1995; White et al., 1995). Several
      other investigations of CBT have demonstrated improvements in depression, pain behaviors, and
      tenderness (Nicassio et al., 1997), as well as knowledge of fibromyalgia and coping with pain
      (Vlaeyen et al., 1996). While the latter two studies did not demonstrate a superiority of CBT
      over educational approaches, a meta-analytic review concluded that psychological
      interventions for fibromyalgia in general produced effect sizes that exceeded those of
      physical therapy or pharmacological interventions for outcomes such as symptoms, mental
      health, and physical functioning (Rossy et al., 1999). The latter outcome, a sustained
      improvement in physical functioning, was the most difficult outcome to achieve for patients
      with fibromyalgia using any form of intervention. One recent study however demonstrated that
      1-year sustained improvements in physical functional status were three times more likely in
      patients that attended a brief course of CBT than if they received only symptom-based
      pharmacological care (Williams, 2002).

      New Advances in CBT Delivery Despite the demonstrated effectiveness of combining
      pharmacological interventions with CBT, 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 (Muehrer, 2000).

      A current technology, Internet websites, has been implemented in an effort to overcome some
      of the barriers that have prevented the delivery of clinical services to FMS populations.

      Healthcare Websites E-learning, the use of a website for education without the use of a live
      instructor, has become a popular method for educating the lay-public, for offering classes
      for credit and for continuing education online, and for training employees new job skills.
      Numerous websites exist that purport to improve health. Some of these sites simply provide
      information about illness, others provide interactive preprogrammed advice, and some send
      tailored health messages to patients.

      The current study will seek to evaluate the effectiveness of using traditional standard care
      with standard care plus Internet web-based educational programming. This will be one of the
      largest randomized controlled trials to use web-based learning and should help to identify
      the feasibility of using this modality to augment standard care for the FMS community.
    

Intervention name(s): Standard care and web; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A static web site containing cognitive and behavioral self management instructions.; Standard care delivered by the primary care provider.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Fibromyalgia; Internet