Condition category
Nervous System Diseases
Date applied
06/07/2007
Date assigned
29/10/2007
Last edited
08/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elise Van de Putte

ORCID ID

Contact details

University Medical Center Utrecht
Postbox 85090
Utrecht
3508 AB
Netherlands
e.vandeputte@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00893438

Protocol/serial number

N/A

Study information

Scientific title

Acronym

FITNET

Study hypothesis

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).

Ethics approval

METC Utrecht gave approval on the 22nd October 2007 (ref: 07-196/K). First patient was included on 30th January 2008.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic Fatigue Syndrome

Intervention

All participants will be randomised to one of the two treatment arms:
1. Intervention with web-based cognitive behavioural treatment
2. Usual care

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

The web-based programme is developed for both the adolescents and the parents. The programme 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 realised.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. School presence
2. Severity of fatigue
3. Physical functioning as measured by the subscale physical functioning

Efficacy of the web-based programme will be determined after these 6 months. The follow-up measurement at 12 months is meant to define if the result.

Secondary outcome measures

Self-rated improvement. Efficacy of the web-based programme will be determined after these 6 months. The follow-up measurement at 12 months is meant to define if the result.

Overall trial start date

01/10/2007

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

140

Participant exclusion criteria

1. Score greater than or equal to 44 on the Stait-Trait Anxiety Inventory for Children
2. Score greater than or equal to 15 on the Children’s Depression Inventory
3. No availability of computer and/or internet
4. Risk of suicide
5. Mental retardation

Recruitment start date

01/10/2007

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Sponsor details

Laan van Nieuw Oost Indië 334
Postbox 93 245
The Hague
2509 AE
Netherlands
info@zonmw.nl

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22385683

Publication citations

  1. Results

    Nijhof SL, Bleijenberg G, Uiterwaal CS, Kimpen JL, van de Putte EM, Effectiveness of internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): a randomised controlled trial., Lancet, 2012, 379, 9824, 1412-1418, doi: 10.1016/S0140-6736(12)60025-7.

Additional files

Editorial Notes