Contact information
Type
Scientific
Primary contact
Prof G. Bleijenberg
ORCID ID
Contact details
University Medical Centre St. Radboud
Expert Centre 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 2005/233; NTR570
Study information
Scientific title
Acronym
Study hypothesis
There are two research questions:
1. Do self-instructions lead to a significant decrease of fatigue and functional impairments of CFS patients compared to a waiting list condition?
2. For which patients are self-instructions a suitable treatment method?
Ethics approval
Received from local medical ethics committees
Study design
Randomised single-blind controlled parallel group 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 baseline assessment patients are randomly assigned to one of two conditions.
In the self-instruction condition patients receive a self-instruction book and email a therapist once every two weeks about their improvements.
In the waiting list condition patients receive no treatment after the baseline assessment.
After a period of 6 to 12 months patients get a second assessment. Both patients in the self-instruction and in the waiting list condition are then offered (regular) individual cognitive behavioural therapy (CBT) for CFS. As there is a waiting period of 6-12 months for individual CBT because of lack of treatment capacity participation in the self-instruction study will not lead to a longer waiting period for treatment as usual.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Fatigue (measured with the CIS-Fatigue severity)
2. Disabilities (measured with the SIP total score and SF-36 subscale 'physical functioning')
3. The CIS-f, SIP and SF-36 are used in two assessments, a baseline and a post-treatment (or post waiting list) assessment
4. Determine the effect of the treatment - the difference in CIS-f, SIP and SF-36 scores between baseline and post-treatment for the treatment condition is compared with the difference scores of the waiting list condition
Secondary outcome measures
Psychological distress measured with the SCL-90 (symptom checklist 90)
Overall trial start date
01/02/2006
Overall trial end date
01/09/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Greater than 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 CIS-fatigue severity score of greater than or equal to 35)
5. Severely disabled (weighted total score on the Sickness Impact Profile of greater than or equal to 700)
6. Being motivated for treatment of CFS
7. Given written informed consent for participation in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
196
Participant exclusion criteria
1. Patient does not meet the herefore mentioned inclusion criteria
2. Patient is currently engaged in a legal procedure concerning disability-related financial benefits
Recruitment start date
01/02/2006
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre St. Radboud
Nijmegen
6500 HB
Netherlands
Sponsor information
Organisation
University Medical Centre 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 Centre St. Radboud (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
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18827302
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23972413
Publication citations
-
Results
Knoop H, van der Meer JW, Bleijenberg G, Guided self-instructions for people with chronic fatigue syndrome: randomised controlled trial., Br J Psychiatry, 2008, 193, 4, 340-341, doi: 10.1192/bjp.bp.108.051292.
-
Results
Goedendorp MM, van der Werf SP, Bleijenberg G, Tummers M, Knoop H, Does neuropsychological test performance predict outcome of cognitive behavior therapy for Chronic Fatigue Syndrome and what is the role of underperformance?, J Psychosom Res, 2013, 75, 3, 242-248, doi: 10.1016/j.jpsychores.2013.07.011.