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