NCT00893438

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

3.8 years

First QC Date

May 5, 2009

Last Update Submit

May 21, 2013

Conditions

Chronic Fatigue Syndrome

Keywords

Chronic Fatigue Syndrome (CFS)AdolescenceCognitive behaviour therapy (CBT)Web-basedInternetEfficacy

Outcome Measures

Primary Outcomes (3)

  • School presence

    one year

  • Severity of fatigue

    one year

  • Physical functioning as measured by the subscale physical functioning

    one year

Secondary Outcomes (1)

  • Self-rated improvement

    one year

Study Arms (2)

FitNet treatment

EXPERIMENTAL

FitNet treatment: web-based cognitive behaviour therapy

Behavioral: FitNet treatment

Usual care

ACTIVE COMPARATOR

waiting list for FitNet intervention (usual care allowed)

Other: Usual care

Interventions

FitNet treatmentBEHAVIORAL

web-based cognitive behavioural treatment for adolescents with CFS

Also known as: CBT, Internet treatment
FitNet treatment
Usual careOTHER

Usual care treatment for adolescents with CFS

Usual care

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Medical Center St. Radboud

Nijmegen, 6500 HB, Netherlands

Location

Wilhelmina Childrens' Hospital (University Medical Center Utrecht)

Utrecht, 3584 CX, Netherlands

Location

Related Publications (2)

  • 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. doi: 10.1136/bmjopen-2015-008830corr1.

    PMID: 26510728DERIVED

  • 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.

    PMID: 21333021DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sanne L Nijhof, MD, PhD-student

    Wilhelmina Childrens' Hospital (University Medical Center Utrecht)

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Ph.D.

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

January 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

NL(2)