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Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268606
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : May 21, 2008
Radboud University
Sint Maartenskliniek
Information provided by:
Radboud University

Brief Summary:
The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: cognitive-behavioral therapy Not Applicable

Detailed Description:

The fibromyalgia syndrome is a chronic condition with widespread pain that poses a great challenge for patients, rheumatologists and society because of the lack of optimal treatment options. There is extensive evidence that, in comparison with patients with rheumatoid arthritis, fibromyalgia patients report higher levels of functional disability, pain, fatigue, and lower levels of quality of life. Although effectiveness of pharmacological agents and other interventions is generally limited, most promising effects have been found for non-pharmacological treatments, particularly those with a primary focus on cognitive-behavioral treatment components. However, also these treatment outcomes are characterized by large individual variation. Particularly patients with less impairments in daily life seem to benefit less from these treatments. In line with the international literature, previous findings of the research group suggest that effectiveness might be increased when tailored cognitive-behavioural treatments are solely offered to patients at risk.

In the present project the effects of tailored interventions based on cognitive-behavioral factors for patients at risk are studied. In a randomized, controlled trial, fibromyalgia patients are screened for risk profiles. Patients at risk will be assigned to tailored cognitive or behavioral treatment conditions, depending on their risk profile with respect to cognitive-behavioral factors. Half of the patients are subsequently randomly assigned to a waiting list control condition. It is expected that this tailored treatment approach will increase magnitude and maintenance of treatment effects for pain, disability, fatigue and increased quality of life, which means an important step forward for patients, involved professionals and society.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial
Study Start Date : December 2003
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Primary Outcome Measures :
  1. pain
  2. disability
  3. fatigue
  4. psychological distress at post treatment and 6 month follow-up

Secondary Outcome Measures :
  1. passive coping
  2. illness cognitions
  3. social support at post treatment and 6 month follow-up

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • fibromyalgia according to the criteria of the American College of Rheumatology (ACR)

Exclusion Criteria:

  • physical or psychological comorbidity that interferes with cognitive-behavioral treatment
  • participation in other clinical trials
  • other psychological treatments
  • pregnancy
  • illiteracy
  • difficulties with understanding Dutch language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268606

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Jeroen Bosch Ziekenhuis, department of Medical Psychology
's-Hertogenbosch, Netherlands
Rijnstate Hospital, department of Rheumatology
Arnhem, Netherlands
Radboud University Medical Centre, department of Rheumatology
Nijmegen, Netherlands
Radboud University Nijmegen Medical Centre, department of Medical Psychology
Nijmegen, Netherlands
Sint Maartenskliniek
Nijmegen, Netherlands
Sponsors and Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
Radboud University
Sint Maartenskliniek
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Study Chair: A.W.M. Evers, Phd Radboud University Nijmegen Medical Centre, department of Medical Psychology
Study Chair: F.W. Kraaimaat, Prof. Phd Radboud University Nijmegen Medical Centre, deparment of Medical Psychology
Study Chair: W. van Lankveld, Phd Sint Maartenskliniek, department of Reseach and Development
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00268606    
Other Study ID Numbers: 60-00636-98-028
NR 05-1-1101
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: May 2008
Keywords provided by Radboud University:
cognitive-behavioral therapy
tailored treatment
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases