Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423631
Status:
COMPLETED
Last Update Posted:
2011-10-10
First Post:
2007-01-17
Brief Title:
Web-based Education to Enhance Fibromyalgia Management
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Internet-Enhanced Management of Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 eg 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 19961994 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 19961994 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None