Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk

Fibromyalgia Clinical Trial

Official title:

Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268606
• Other study ID #: 60-00636-98-028
• Secondary ID: NR 05-1-1101
• Status: Completed
• Phase: N/A
• First received: December 21, 2005
• Last updated: May 20, 2008
• Start date: December 2003
• Est. completion date: December 2007

Study information

• Verified date: May 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• cognitive-behavioral therapy

Locations

Country	Name	City	State
Netherlands	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

Sponsors (4)

Lead Sponsor	Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development	Radboud University, Reumafonds, Sint Maartenskliniek

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain
Primary	disability
Primary	fatigue
Primary	psychological distress at post treatment and 6 month follow-up
Secondary	passive coping
Secondary	illness cognitions
Secondary	social support at post treatment and 6 month follow-up