Clinical trial NCT00893438: Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With Chronic Fatigue Syndrome
Official title: Fatigue in Teenagers on the Internet (FitNet); Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With the Chronic Fatigue Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Fatigue Syndrome
Keywords: Chronic Fatigue Syndrome (CFS)
Adolescence
Cognitive behaviour therapy (CBT)
Web-based
Internet
Efficacy
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Innovatiefonds Zorgverzekeraars
First posted: 2009-05-06
Enrollment: 135
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: School presence
timeFrame: one year
measure: Severity of fatigue
timeFrame: one year
measure: Physical functioning as measured by the subscale physical functioning
timeFrame: one year
Secondary outcomes:
measure: Self-rated improvement
timeFrame: one year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: University Medical Center St. Radboud
city: Utrecht
country: Netherlands
facility: Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Study officials:
affiliation: Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
name: Sanne L Nijhof, MD, PhD-student
role: PRINCIPAL_INVESTIGATOR
affiliation: Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
name: Elise M van de Putte, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Medical Center St. Radboud
name: Gijs Bleijenberg, Prof
role: STUDY_DIRECTOR
affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
name: Cuno SP Uiterwaal, MD, PHD
role: STUDY_DIRECTOR
affiliation: UMC Utrecht
name: Jan JL Kimpen, Prof.
role: STUDY_DIRECTOR
References:
citation: Collin SM, Nuevo R, van de Putte EM, Nijhof SL, Crawley E. Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) is different in children compared to in adults: a study of UK and Dutch clinical cohorts. BMJ Open. 2015 Oct 28;5(10):e008830. doi: 10.1136/bmjopen-2015-008830.
citation: Nijhof SL, Bleijenberg G, Uiterwaal CS, Kimpen JL, van de Putte EM. Fatigue In Teenagers on the interNET--the FITNET Trial. A randomized clinical trial of web-based cognitive behavioural therapy for adolescents with chronic fatigue syndrome: study protocol. [ISRCTN59878666]. BMC Neurol. 2011 Feb 19;11:23. doi: 10.1186/1471-2377-11-23.