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Discussion in 'Active Clinical Studies' started by Cort, Jun 15, 2009.

  1. Cort

    Cort Phoenix Rising Founder

    Descriptive Information

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

    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.

    Study Phase
    Study Type ICMJE Interventional
    Study Design ICMJE Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
    Condition ICMJE Chronic Fatigue Syndrome
    Intervention ICMJE
    Behavioral: FitNet treatment
    Other: Usual care
    Study Arms / Comparison Groups
    Experimental: FitNet treatment: web-based cognitive behaviour therapy
    Active Comparator: waiting list for FitNet intervention (usual care allowed)
    Publications *

    * Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

    Recruitment Information
    Recruitment Status ICMJE Recruiting
    Estimated Enrollment ICMJE 120
    Estimated Completion Date October 2010
    Estimated Primary Completion Date October 2009 (final data collection date for primary outcome measure)
    Eligibility Criteria ICMJE
    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
    Gender Both
    Ages 12 Years to 18 Years
    Accepts Healthy Volunteers Yes
    Contacts ICMJE
    Contact: Sanne L Nijhof, MD PhD-student 0031887554555
    Contact: Elise M van de Putte, MD PhD 0031887554555
    Location Countries ICMJE Netherlands
    Expanded Access Status

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