Condition category
Nervous System Diseases
Date applied
12/10/2006
Date assigned
12/10/2006
Last edited
12/10/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Professor G Bleijenberg
ORCID ID
Contact details
University Medical Center St. Radboud
Expert Center Chronic Fatigue
P.O. Box 9011
Nijmegen
6500 HB
Netherlands
+31 (0)24 3610030
g.bleijenberg@nkcv.umcn.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CMO 2006/030
Study information
Scientific title
Acronym
Study hypothesis
There are two research questions:
1. Does Cognitive Behavioural Therapy (CBT) in groups lead to a significant decrease of fatigue and functional impairment of Chronic Fatigue Syndrome (CFS) patients compared to a waiting list condition?
2. For which patient is group therapy a suitable treatment method?
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic Fatigue Syndrome (CFS)
Intervention
After a basline assessment patients are randomly assigned to one of three conditions. There are two treatment conditions: small group (four patients and one therapist) and large group (eight patients and two therapists). Both group treatments consist of 16 sessions of two hours in a period of about six months. There is a second assessment after the treatment. The third condition is a waiting list condition. After the waiting period of at least six months, patients get a second assessment.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Fatigue severity (measured with the CIS subscale fatigue severity).
2. Disabilities (measured with the Sickness Impact Profile (SIP) total score and the Short form health survey (SF-36) subscale 'physical functioning'). The CIS-f, SIP and SF-36 are used in two assessments, a baseline and a post-treatment (or post-waiting list) assessment. The change score between post-treatment and baseline of each of the treatment conditions is compared with the difference score between post-waiting list and baseline assessment of the waiting list condition.
Secondary outcome measures
Psychological distress measured with the Symptom Checklist 90 (SCL 90).
Overall trial start date
01/01/2008
Overall trial end date
01/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Over 18 years old
2. Being able to speak and read Dutch
3. Meeting the 1994 research criteria for CFS as formulated by the US Center for Disease Control
4. Severely fatigued (having a Checklist Individual Strength (CIS)-fatigue severity score of more than or equal to 35)
5. Severely disabled (weighted total score on the Sickness Impact Profile of more than or equal to 700)
6. Motivated for treatment of CFS with CBT
7. Having functioned good in groups before (self-report) and willing to follow a group treatment for CFS
8. Given written informed consent for participation in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
204
Participant exclusion criteria
1. Patient does not meet the previously mentioned inclusion criteria
2. Patient is currently engaged in a legal procedure concerning disability-related financial benefits
Recruitment start date
01/01/2008
Recruitment end date
01/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center St. Radboud
Nijmegen
6500 HB
Netherlands
Sponsor information
Organisation
University Medical Center St. Radboud (The Netherlands)
Sponsor details
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 3611111
info@ozi.umcn.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Center St. Radboud (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations
Additional files
Editorial Notes