Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk

This study has been completed.
Sponsor:
Collaborators:
Reumafonds
Radboud University
Sint Maartenskliniek
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00268606
First received: December 21, 2005
Last updated: May 20, 2008
Last verified: May 2008
  Purpose

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 Intervention
Fibromyalgia
Behavioral: cognitive-behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • pain
  • disability
  • fatigue
  • psychological distress at post treatment and 6 month follow-up

Secondary Outcome Measures:
  • passive coping
  • illness cognitions
  • social support at post treatment and 6 month follow-up

Estimated Enrollment: 400
Study Start Date: December 2003
Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268606

Locations
Netherlands
Jeroen Bosch Ziekenhuis, department of Medical Psychology
's-Hertogenbosch, Netherlands
Rijnstate Hospital, department of Rheumatology
Arnhem, Netherlands
Radboud University Nijmegen Medical Centre, department of Medical Psychology
Nijmegen, Netherlands
Sint Maartenskliniek
Nijmegen, Netherlands
Radboud University Medical Centre, department of Rheumatology
Nijmegen, Netherlands
Sponsors and Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
Reumafonds
Radboud University
Sint Maartenskliniek
Investigators
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
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00268606     History of Changes
Other Study ID Numbers: 60-00636-98-028, NR 05-1-1101
Study First Received: December 21, 2005
Last Updated: May 20, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
fibromyalgia
cognitive-behavioral therapy
tailored treatment

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 19, 2014