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

Chronic Fatigue Syndrome Clinical Trial

— FitNet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893438
• Other study ID #: ZonMW-56100004
• Secondary ID: ISRCTN59878666
• Status: Completed
• Phase: N/A
• First received: May 5, 2009
• Last updated: May 21, 2013
• Start date: January 2008
• Est. completion date: November 2011

Study information

• Verified date: May 2013
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Behavioral:
• FitNet treatment
web-based cognitive behavioural treatment for adolescents with CFS

Other:
• Usual care
Usual care treatment for adolescents with CFS

Locations

Country	Name	City	State
Netherlands	University Medical Center St. Radboud	Nijmegen
Netherlands	Wilhelmina Childrens' Hospital (University Medical Center Utrecht)	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Innovatiefonds Zorgverzekeraars (Rvvz), ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	School presence		one year
Primary	Severity of fatigue		one year
Primary	Physical functioning as measured by the subscale physical functioning		one year
Secondary	Self-rated improvement		one year

External Links

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