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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00268606 |
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Date of registration:
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21/12/2005 |
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Primary sponsor: |
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Public title:
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Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk
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Scientific title:
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Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial |
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Date of first enrolment:
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December 2003 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00268606 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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F.W. Kraaimaat, Prof. Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Radboud University Nijmegen Medical Centre, deparment of Medical Psychology |
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Name:
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A.W.M. Evers, Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Radboud University Nijmegen Medical Centre, department of Medical Psychology |
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Name:
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W. van Lankveld, Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sint Maartenskliniek, department of Reseach and Development |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fibromyalgia
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Intervention(s)
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Behavioral: cognitive-behavioral therapy
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Primary Outcome(s)
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disability
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fatigue
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pain
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psychological distress at post treatment and 6 month follow-up
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Secondary Outcome(s)
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illness cognitions
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passive coping
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social support at post treatment and 6 month follow-up
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Secondary ID(s)
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60-00636-98-028
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NR 05-1-1101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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