Condition category
Nervous System Diseases
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
27/03/2014
Prospective/Retrospective
Retrospectively 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

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

  1. 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.

  2. 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.

Additional files

Editorial Notes