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