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Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With Chronic Fatigue Syndrome (FitNet)

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ClinicalTrials.gov Identifier: NCT00893438
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : May 22, 2013
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Innovatiefonds Zorgverzekeraars
Information provided by (Responsible Party):
E.M. van de Putte, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE May 5, 2009
First Posted Date  ICMJE May 6, 2009
Last Update Posted Date May 22, 2013
Study Start Date  ICMJE January 2008
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2009)
  • School presence [ Time Frame: one year ]
  • Severity of fatigue [ Time Frame: one year ]
  • Physical functioning as measured by the subscale physical functioning [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00893438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2009)
Self-rated improvement [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With Chronic Fatigue Syndrome
Official Title  ICMJE Fatigue in Teenagers on the Internet (FitNet); Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With the Chronic Fatigue Syndrome
Brief Summary 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).
Detailed Description

All participants will be randomized to one of the two treatment arms:

  1. Intervention with web-based cognitive behavioral treatment
  2. Usual care

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

The web-based program is developed for both the adolescents and the parents. The program 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 realized.

Efficacy of the web-based program will be determined after 6 months. There will be a follow-up measurement at 12 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Fatigue Syndrome
Intervention  ICMJE
  • Behavioral: FitNet treatment
    web-based cognitive behavioural treatment for adolescents with CFS
    Other Names:
    • CBT
    • Internet treatment
  • Other: Usual care
    Usual care treatment for adolescents with CFS
Study Arms  ICMJE
  • Experimental: FitNet treatment
    FitNet treatment: web-based cognitive behaviour therapy
    Intervention: Behavioral: FitNet treatment
  • Active Comparator: Usual care
    waiting list for FitNet intervention (usual care allowed)
    Intervention: Other: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2013)
135
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2009)
120
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adolescents (12 - 18 years) with Chronic Fatigue Syndrome

Exclusion Criteria:

  • Score greater than or equal to 44 on the Stait-Trait Anxiety Inventory for Children
  • Score greater than or equal to 20 on the Children's Depression Inventory
  • No availability of computer and/or internet
  • Risk of suicide
  • Mental retardation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00893438
Other Study ID Numbers  ICMJE ZonMW-56100004
ISRCTN59878666
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party E.M. van de Putte, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Innovatiefonds Zorgverzekeraars
Investigators  ICMJE
Principal Investigator: Sanne L Nijhof, MD, PhD-student Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Study Director: Elise M van de Putte, MD, PhD Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Study Director: Gijs Bleijenberg, Prof University Medical Center St. Radboud
Study Director: Cuno SP Uiterwaal, MD, PHD Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Study Director: Jan JL Kimpen, Prof. UMC Utrecht
PRS Account UMC Utrecht
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP