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Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk

NCT ID: NCT00268606

Last Updated: 2008-05-21

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fibromyalgia

Keywords

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fibromyalgia cognitive-behavioral therapy tailored treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cognitive-behavioral therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reumafonds

UNKNOWN

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Sint Maartenskliniek

OTHER

Sponsor Role collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role lead

Principal Investigators

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A.W.M. Evers, Phd

Role: STUDY_CHAIR

Radboud University Nijmegen Medical Centre, department of Medical Psychology

F.W. Kraaimaat, Prof. Phd

Role: STUDY_CHAIR

Radboud University Nijmegen Medical Centre, deparment of Medical Psychology

W. van Lankveld, Phd

Role: STUDY_CHAIR

Sint Maartenskliniek, department of Reseach and Development

Locations

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Jeroen Bosch Ziekenhuis, department of Medical Psychology

's-Hertogenbosch, , Netherlands

Site Status

Rijnstate Hospital, department of Rheumatology

Arnhem, , Netherlands

Site Status

Radboud University Medical Centre, department of Rheumatology

Nijmegen, , Netherlands

Site Status

Radboud University Nijmegen Medical Centre, department of Medical Psychology

Nijmegen, , Netherlands

Site Status

Sint Maartenskliniek

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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van Koulil S, van Lankveld W, Kraaimaat FW, van Helmond T, Vedder A, van Hoorn H, Donders AR, Wirken L, Cats H, van Riel PL, Evers AW. Tailored cognitive-behavioural therapy and exercise training improves the physical fitness of patients with fibromyalgia. Ann Rheum Dis. 2011 Dec;70(12):2131-3. doi: 10.1136/ard.2010.148577. Epub 2011 Sep 16.

Reference Type DERIVED
PMID: 21926189 (View on PubMed)

van Koulil S, Kraaimaat FW, van Lankveld W, van Helmond T, Vedder A, van Hoorn H, Donders AR, Thieme K, Cats H, van Riel PL, Evers AW. Cognitive-behavioral mechanisms in a pain-avoidance and a pain-persistence treatment for high-risk fibromyalgia patients. Arthritis Care Res (Hoboken). 2011 Jun;63(6):800-7. doi: 10.1002/acr.20445.

Reference Type DERIVED
PMID: 21312345 (View on PubMed)

van Koulil S, van Lankveld W, Kraaimaat FW, van Helmond T, Vedder A, van Hoorn H, Donders R, de Jong AJ, Haverman JF, Korff KJ, van Riel PL, Cats HA, Evers AW. Tailored cognitive-behavioral therapy and exercise training for high-risk patients with fibromyalgia. Arthritis Care Res (Hoboken). 2010 Oct;62(10):1377-85. doi: 10.1002/acr.20268.

Reference Type DERIVED
PMID: 20521308 (View on PubMed)

van Koulil S, Kraaimaat FW, van Lankveld W, van Riel PL, Evers AW. A patient's perspective on multidisciplinary treatment gain for fibromyalgia: an indicator for pre-post treatment effects? Arthritis Rheum. 2009 Dec 15;61(12):1626-32. doi: 10.1002/art.24792.

Reference Type DERIVED
PMID: 19950305 (View on PubMed)

Other Identifiers

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NR 05-1-1101

Identifier Type: -

Identifier Source: secondary_id

60-00636-98-028

Identifier Type: -

Identifier Source: org_study_id