Fibromyalgia Clinical Trial
Official title:
Internet-Enhanced Management of Fibromyalgia
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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