Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
118 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-09-30
Study Completion Date
2008-04-30
Brief Summary
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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
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
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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.
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.
Conditions
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Fibromyalgia
Fibrositis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Standard Care and Web
Standard care plus a web site based on cognitive behavioral principals.
Group Type
EXPERIMENTAL
Standard care and web
Intervention Type
BEHAVIORAL
A static web site containing cognitive and behavioral self management instructions.
Standard Care
Subject recieve standard care from their primary care provider.
Group Type
ACTIVE_COMPARATOR
Standard Care
Intervention Type
BEHAVIORAL
Standard care delivered by the primary care provider.
Interventions
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Standard care and web
A static web site containing cognitive and behavioral self management instructions.
Intervention Type
BEHAVIORAL
Standard Care
Standard care delivered by the primary care provider.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
1. Ability to travel to Sioux Falls, SD for study visits.
2. All subjects must fulfill the diagnostic criteria for fibromyalgia as established by the American College of Rheumatology (ACR) in 1990 (Wolfe et al., 1990)
3. Be 18 years of age
4. All subjects must have been in standard medical care with a physician for at least 3 months.
5. 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
6. 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
2. All subjects must fulfill the diagnostic criteria for fibromyalgia as established by the American College of Rheumatology (ACR) in 1990 (Wolfe et al., 1990)
3. Be 18 years of age
4. All subjects must have been in standard medical care with a physician for at least 3 months.
5. 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
6. 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
Exclusion Criteria
Subjects will be excluded from participation if they have any of the following:
1. A severe physical impairment that precludes receiving/using the website or using the CBT skills contained on the website (e.g. complete blindness)
2. 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.
3. 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.
4. Prior face to face CBT for pain management.
5. Receiving or applying for or considering seeking disability payments.
1. A severe physical impairment that precludes receiving/using the website or using the CBT skills contained on the website (e.g. complete blindness)
2. 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.
3. 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.
4. Prior face to face CBT for pain management.
5. Receiving or applying for or considering seeking disability payments.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Michigan
OTHER
Sponsor Role
lead
Responsible Party
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David A. Williams
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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David A Williams, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Avera Research Institute
Sioux Falls, South Dakota, United States
Site Status
Countries
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United States
References
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Other Identifiers
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DAMD 17-002-0018, A-9356.1
Identifier Type: -
Identifier Source: org_study_id