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

Primary Purpose

Chronic Fatigue Syndrome

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
FitNet treatment
Usual care
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Chronic Fatigue Syndrome (CFS), Adolescence, Cognitive behaviour therapy (CBT), Web-based, Internet, Efficacy

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Medical Center St. Radboud
  • Wilhelmina Childrens' Hospital (University Medical Center Utrecht)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FitNet treatment

Usual care

Arm Description

FitNet treatment: web-based cognitive behaviour therapy

waiting list for FitNet intervention (usual care allowed)

Outcomes

Primary Outcome Measures

School presence
Severity of fatigue
Physical functioning as measured by the subscale physical functioning

Secondary Outcome Measures

Self-rated improvement

Full Information

First Posted
May 5, 2009
Last Updated
May 21, 2013
Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Innovatiefonds Zorgverzekeraars
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1. Study Identification

Unique Protocol Identification Number
NCT00893438
Brief Title
Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With Chronic Fatigue Syndrome
Acronym
FitNet
Official Title
Fatigue in Teenagers on the Internet (FitNet); Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With the Chronic Fatigue Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Innovatiefonds Zorgverzekeraars

4. Oversight

Data Monitoring Committee
Yes

5. 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).
Detailed Description
All participants will be randomized to one of the two treatment arms: Intervention with web-based cognitive behavioral treatment 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
Chronic Fatigue Syndrome (CFS), Adolescence, Cognitive behaviour therapy (CBT), Web-based, Internet, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FitNet treatment
Arm Type
Experimental
Arm Description
FitNet treatment: web-based cognitive behaviour therapy
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
waiting list for FitNet intervention (usual care allowed)
Intervention Type
Behavioral
Intervention Name(s)
FitNet treatment
Other Intervention Name(s)
CBT, Internet treatment
Intervention Description
web-based cognitive behavioural treatment for adolescents with CFS
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care treatment for adolescents with CFS
Primary Outcome Measure Information:
Title
School presence
Time Frame
one year
Title
Severity of fatigue
Time Frame
one year
Title
Physical functioning as measured by the subscale physical functioning
Time Frame
one year
Secondary Outcome Measure Information:
Title
Self-rated improvement
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanne L Nijhof, MD, PhD-student
Organizational Affiliation
Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elise M van de Putte, MD, PhD
Organizational Affiliation
Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gijs Bleijenberg, Prof
Organizational Affiliation
University Medical Center St. Radboud
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cuno SP Uiterwaal, MD, PHD
Organizational Affiliation
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jan JL Kimpen, Prof.
Organizational Affiliation
UMC Utrecht
Official's Role
Study Director
Facility Information:
Facility Name
University Medical Center St. Radboud
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
26510728
Citation
Collin SM, Nuevo R, van de Putte EM, Nijhof SL, Crawley E. Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) is different in children compared to in adults: a study of UK and Dutch clinical cohorts. BMJ Open. 2015 Oct 28;5(10):e008830. doi: 10.1136/bmjopen-2015-008830. Erratum In: BMJ Open. 2019 Nov 20;9(11):e008830corr1.
Results Reference
derived
PubMed Identifier
21333021
Citation
Nijhof SL, Bleijenberg G, Uiterwaal CS, Kimpen JL, van de Putte EM. Fatigue In Teenagers on the interNET--the FITNET Trial. A randomized clinical trial of web-based cognitive behavioural therapy for adolescents with chronic fatigue syndrome: study protocol. [ISRCTN59878666]. BMC Neurol. 2011 Feb 19;11:23. doi: 10.1186/1471-2377-11-23.
Results Reference
derived
Links:
URL
http://www.umcutrecht.nl/subsite/cvs
Description
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Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With Chronic Fatigue Syndrome

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