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Completed

NCT Number: NCT00893438

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

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).

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Key information

Conditions

Chronic Fatigue Syndrome Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center St. Radboud, Nijmegen, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FitNet treatment

Behavioral

web-based cognitive behavioural treatment for adolescents with CFS

Other names: CBT, Internet treatment

Usual Care

Other

Usual care treatment for adolescents with CFS

Primary outcomes

  1. School presence

    Time frame: one year

  2. Severity of fatigue

    Time frame: one year

  3. Physical functioning as measured by the subscale physical functioning

    Time frame: one year

Secondary outcomes

  1. Self-rated improvement

    Time frame: one year

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Innovatiefonds Zorgverzekeraars
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: FitNet

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 6, 2009
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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