The effectiveness of self-instructions in the treatment of patients with chronic fatigue syndrome (CFS): a randomised controlled study

ISRCTN	ISRCTN27293439
DOI	https://doi.org/10.1186/ISRCTN27293439
Protocol serial number	CMO 2005/233; NTR570
Sponsor	University Medical Centre St. Radboud (The Netherlands)
Funder	University Medical Centre St. Radboud (Netherlands)

Submission date: 14/02/2006
Registration date: 14/02/2006
Last edited: 27/03/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof G. Bleijenberg
Scientific

University Medical Centre St. Radboud
Expert Centre Chronic Fatigue
P.O. Box 9011
Nijmegen
6500 HB
Netherlands

Phone	+31 (0)24 3610030
Email	g.bleijenberg@nkcv.umcn.nl

Study information

Primary study design	Interventional
Study design	Randomised single-blind controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Received from local medical ethics committees
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Psychological distress measured with the SCL-90 (symptom checklist 90)
Completion date	01/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	196
Key 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
Key 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
Date of first enrolment	01/02/2006
Date of final enrolment	01/09/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Centre St. Radboud

Nijmegen
6500 HB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2008		Yes	No
Results article	results	01/09/2013		Yes	No