Clinical trial NCT00268606: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk
Official title: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
cognitive-behavioral therapy
tailored treatment
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Reumafonds
name: Radboud University Medical Center
name: Sint Maartenskliniek
First posted: 2005-12-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: pain
measure: disability
measure: fatigue
measure: psychological distress at post treatment and 6 month follow-up
Secondary outcomes:
measure: passive coping
measure: illness cognitions
measure: social support at post treatment and 6 month follow-up
Other outcomes:
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis, department of Medical Psychology
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital, department of Rheumatology
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre, department of Rheumatology
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre, department of Medical Psychology
city: Nijmegen
country: Netherlands
facility: Sint Maartenskliniek
Study officials:
affiliation: Radboud University Nijmegen Medical Centre, department of Medical Psychology
name: A.W.M. Evers, Phd
role: STUDY_CHAIR
affiliation: Radboud University Nijmegen Medical Centre, deparment of Medical Psychology
name: F.W. Kraaimaat, Prof. Phd
role: STUDY_CHAIR
affiliation: Sint Maartenskliniek, department of Reseach and Development
name: W. van Lankveld, Phd
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.