An interventional study of cognitive-behavioral therapy in Fibromyalgia, sponsored by ZonMw: The Netherlands Organisation for Health Research and Development. Completed at 5 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-05-21.
Sponsored by ZonMw: The Netherlands Organisation for Health Research and Development · Not applicable, Interventional, and Treatment
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.
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.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →ZonMw: The Netherlands Organisation for Health Research and Development is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
pain
disability
fatigue
psychological distress at post treatment and 6 month follow-up
passive coping
illness cognitions
social support at post treatment and 6 month follow-up
This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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ZonMw: The Netherlands Organisation for Health Research and Development