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.
Status | Completed |
Enrollment | 400 |
Est. completion date | December 2007 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
ZonMw: The Netherlands Organisation for Health Research and Development | Radboud University, Reumafonds, Sint Maartenskliniek |
Netherlands,
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 |
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