The effectiveness of cognitive behavioural therapy in groups for patients with Chronic Fatigue Syndrome (CFS): a randomised controlled study

ISRCTN	ISRCTN15823716
DOI	https://doi.org/10.1186/ISRCTN15823716
Secondary identifying numbers	CMO 2006/030

Submission date: 12/10/2006
Registration date: 12/10/2006
Last edited: 12/10/2006

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Professor G Bleijenberg
Scientific

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

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
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(s)	Ethics approval received from the local medical ethics committee
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
Primary outcome measure	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 study start date	01/01/2008
Overall study end date	01/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	204
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 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

Study participating centre

University Medical Center St. Radboud

Nijmegen
6500 HB
Netherlands

Sponsor information

University Medical Center St. Radboud (The Netherlands)
Hospital/treatment centre

P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Phone	+31 (0)24 3611111
Email	info@ozi.umcn.nl
"ROR"	https://ror.org/05wg1m734

Funders

Funder type

Hospital/treatment centre

University Medical Center St. Radboud (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan