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


- candidate number2176
- NTR NumberNTR737
- ISRCTNISRCTN15823716
- Date ISRCTN created12-okt-2006
- date ISRCTN requested11-okt-2006
- Date Registered NTR21-jul-2005
- Secondary IDsCMO 2006/030 
- Public TitleThe effectiveness of cognitive behavioural therapy in groups for patients with Chronic Fatigue Syndrome (CFS): a randomised controlled study.
- Scientific TitleThe effectiveness of cognitive behavioural therapy in groups for patients with Chronic Fatigue Syndrome (CFS): a randomised controlled study.
- ACRONYMN/A
- hypothesisThere are two research questions: 1. Does cognitive behavioural therapy (CBT) in groups lead to a significant decrease of fatigue and functional impairment of CFS patients compared to a waiting list condition? 2. For which patient is group therapy a suitable treatment method?
- Healt Condition(s) or Problem(s) studiedChronic Fatigue Syndrome (CFS)
- Inclusion criteria1. > 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 Diasease Control; 4. Severely fatigued (having a CIS-fatigue severity score of >=35); 5. Severely disabled (weigthed totalscore on the Sickness Impact Profile of >=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.
- Exclusion criteria1. Patient does no meet the herefore mentioned inclusion criteria; 2. Patients is currently engaged in a legal procedure concerning disability-related financial benefits.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-2007
- planned closingdate1-dec-2010
- Target number of participants204
- InterventionsAfter a basline assessment patients are randomly assigned to one of three conditions. The are two treatment conditions: small group (4 patients and 1 therapist) and large group (8 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 a least 6 months patients get a second assessment.
- Primary outcome1. Fatigue severity (measured with the CIS subscale fatigue severity). 2. Disabilities (measured with the SIP total score and the SF-36 subscal '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 outcomePsychological distress measured with the Symptom Checklist 90 (SCL_90).
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. G. Bleijenberg
- CONTACT for SCIENTIFIC QUERIESProf. Dr. G. Bleijenberg
- Sponsor/Initiator University Medical Center St. Radboud
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center St. Radboud
- PublicationsN/A
- Brief summaryChronic Fatigue Syndrome (CFS) is characterised by severe fatigue, lasting longer than six months and leading to functional impairment. It is not the result of an organic disease or ongoing exertion and not alleviated by rest. The aetiology of CFS is unknown, but cognitions and behaviour can perpetuate CFS. Several controlled trials have shown that individual Cognitive Behaviour Therapy (CBT) aimed at these perpetuating factors leads to a reduction of fatigue and disabilities. In the Netherlands there a between 30.000 and 40.000 CFS patients while at the same time the availability of individual CBT for CFS is limited due to a limited treatment capacity. It is important to develop treatment programmes that require less treatment capacity. Group treatment is an example of such a treatment program. An earlier study showed that CBT for CFS in a group was not effective (Bazelmans et al, 2005). On the basis of this study a new protocol for group CBT for CFS was developed in the Expert Centre Chronic Fatigue of the Radboud University Nijmegen Medical Centre. The two objectives of the current study are 1) to evaluate the efficacy of a cognitive behavioural treatment in groups for CFS 2) to find out for which CFS patients group treatment is specifically suitable. This is a randomised controlled trial in which two types of group treatment (treatm in a small group of 4 patients and a treatment in a larger group of 8 patients) are compared with a waiting list condition. Patients are included if they meet the 1994 US Center for Disease Control criteria for CFS, are severely fatigued and disabled, are willing to follow group treatment and gave their written informed consent. Consecutive patients are randomly assigned to the two treatment conditions or a waiting list condition. All patients are assessed again after treatment or the waiting period. The main outcome measures are fatigue severity (CIS) and functional impairment (SF-36 and SIP).
- Main changes (audit trail)
- RECORD24-jul-2006 - 20-jan-2010


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