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Efficacy of web-based cognitive behavioural treatment for adolescents with the Chronic Fatigue Syndrome
ISRCTN ISRCTN59878666
DOI 10.1186/ISRCTN59878666
ClinicalTrials.gov identifier NCT00893438
EudraCT number
Public title Efficacy of web-based cognitive behavioural treatment for adolescents with the Chronic Fatigue Syndrome
Scientific title
Acronym FITNET
Serial number at source N/A
Study hypothesis The aim of this study is to determine the efficacy of FITNET (web-based cognitive behavioural treatment) for adolescents with Chronic Fatigue Syndrome (CFS) in The Netherlands. The second goal of the study is to establish predictors of outcome. It is very important to know the characteristics of patients who will benefit from Cognitive Behavioural Treatment (CBT) and who will not. Possible predictors of outcome are: age, depression, anxiety, fatigue of the mother, parental bonding, self-efficacy, body consciousness of child and mother, physical activity (Actometer).
Lay summary Not provided at time of registration
Ethics approval METC Utrecht gave approval on the 22nd October 2007 (ref: 07-196/K). First patient was included on 30th January 2008.
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Chronic Fatigue Syndrome
Participants - inclusion criteria Adolescents (12 - 18 years) with Chronic Fatigue Syndrome.
Participants - exclusion criteria 1. Score greater than or equal to 44 on the Stait-Trait Anxiety Inventory for Children
2. Score greater than or equal to 15 on the Children’s Depression Inventory
3. No availability of computer and/or internet
4. Risk of suicide
5. Mental retardation
Anticipated start date 01/10/2007
Anticipated end date 01/10/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 140
Interventions All participants will be randomised to one of the two treatment arms:
1. Intervention with web-based cognitive behavioural treatment
2. Usual care

The duration of the cognitive behavioural programme is limited to 6 months. The adolescents who have been assigned to the usual care will get the opportunity to attend the programme after these 6 months. The total follow-up time is 12 months after the start of the web-based programme.

The web-based programme is developed for both the adolescents and the parents. The programme consists of two parts, a psycho-educational part and a cognitive behavioural part consisting of 21 treatment modules. The therapist activates one or more treatment modules per week, dependent on the progress of the participant. Within a treatment module the participant will keep several journals, answer questions and do several assignments. All answers are sent to the therapist, with whom a weekly email contact will be realised.
Primary outcome measure(s) 1. School presence
2. Severity of fatigue
3. Physical functioning as measured by the subscale physical functioning

Efficacy of the web-based programme will be determined after these 6 months. The follow-up measurement at 12 months is meant to define if the result.
Secondary outcome measure(s) Self-rated improvement. Efficacy of the web-based programme will be determined after these 6 months. The follow-up measurement at 12 months is meant to define if the result.
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22385683
Contact name Dr  Elise  Van de Putte
  Address University Medical Center Utrecht
Postbox 85090
  City/town Utrecht
  Zip/Postcode 3508 AB
  Country Netherlands
  Email e.vandeputte@umcutrecht.nl
Sponsor The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
  Address Laan van Nieuw Oost Indië 334
Postbox 93 245
  City/town The Hague
  Zip/Postcode 2509 AE
  Country Netherlands
  Email info@zonmw.nl
Date applied 06/07/2007
Last edited 08/05/2012
Date ISRCTN assigned 29/10/2007
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