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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Fatigue Syndrome

Intervention / Treatment
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* Behavioral: FitNet treatment
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FitNet treatment<br>FitNet treatment: web-based cognitive behaviour therapy | Behavioral: FitNet treatment<br>* web-based cognitive behavioural treatment for adolescents with CFS<br>* Other names: Internet treatment;|
| Active Comparator: Usual care<br>waiting list for FitNet intervention (usual care allowed) | Other: Usual care<br>* Usual care treatment for adolescents with CFS<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-rated improvement |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Fatigue Syndrome (CFS), Adolescence, Cognitive behaviour therapy (CBT), Web-based, Internet, Efficacy