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

May 21, 2013 updated by: E.M. van de Putte, UMC Utrecht

Fatigue in Teenagers on the Internet (FitNet); Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With the Chronic Fatigue Syndrome

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • University Medical Center St. Radboud
      • Utrecht, Netherlands, 3584 CX
        • Wilhelmina Childrens' Hospital (University Medical Center Utrecht)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
School presence
Time Frame: one year
one year
Severity of fatigue
Time Frame: one year
one year
Physical functioning as measured by the subscale physical functioning
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-rated improvement
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development
Innovatiefonds Zorgverzekeraars

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

May 5, 2009

First Submitted That Met QC Criteria

May 5, 2009

First Posted (ESTIMATE)

May 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 22, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZonMW-56100004
  • ISRCTN59878666

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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