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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
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Chronic Fatigue Syndrome Behavioral: FitNet treatment Other: Usual care

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fatigue in Teenagers on the Internet (FitNet); Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With the Chronic Fatigue Syndrome
Study Start Date : January 2008
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: FitNet treatment
FitNet treatment: web-based cognitive behaviour therapy
Behavioral: FitNet treatment
web-based cognitive behavioural treatment for adolescents with CFS
Other Names:
  • CBT
  • Internet treatment
Active Comparator: Usual care
waiting list for FitNet intervention (usual care allowed)
Other: Usual care
Usual care treatment for adolescents with CFS

Outcome Measures

Primary Outcome Measures :
  1. School presence [ Time Frame: one year ]
  2. Severity of fatigue [ Time Frame: one year ]
  3. Physical functioning as measured by the subscale physical functioning [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Self-rated improvement [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893438

University Medical Center St. Radboud
Nijmegen, Netherlands, 6500 HB
Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Innovatiefonds Zorgverzekeraars (Rvvz)
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
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: E.M. van de Putte, M.D. Ph.D., UMC Utrecht
ClinicalTrials.gov Identifier: NCT00893438     History of Changes
Other Study ID Numbers: ZonMW-56100004
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

Keywords provided by E.M. van de Putte, UMC Utrecht:
Chronic Fatigue Syndrome (CFS)
Cognitive behaviour therapy (CBT)

Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases