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

This study has been completed.
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Innovatiefonds Zorgverzekeraars (Rvvz)
Information provided by (Responsible Party):
E.M. van de Putte, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00893438
First received: May 5, 2009
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention
Chronic Fatigue Syndrome
Behavioral: FitNet treatment
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fatigue in Teenagers on the Internet (FitNet); Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With the Chronic Fatigue Syndrome

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • School presence [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Severity of fatigue [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Physical functioning as measured by the subscale physical functioning [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-rated improvement [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FitNet treatment
FitNet treatment: web-based cognitive behaviour therapy
Behavioral: FitNet treatment
web-based cognitive behavioural treatment for adolescents with CFS
Other Names:
  • CBT
  • Internet treatment
Active Comparator: Usual care
waiting list for FitNet intervention (usual care allowed)
Other: Usual care
Usual care treatment for adolescents with CFS

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

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893438

Locations
Netherlands
University Medical Center St. Radboud
Nijmegen, Netherlands, 6500 HB
Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Innovatiefonds Zorgverzekeraars (Rvvz)
Investigators
Principal Investigator: Sanne L Nijhof, MD, PhD-student Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Study Director: Elise M van de Putte, MD, PhD Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Study Director: Gijs Bleijenberg, Prof University Medical Center St. Radboud
Study Director: Cuno SP Uiterwaal, MD, PHD Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Study Director: Jan JL Kimpen, Prof. UMC Utrecht
  More Information

Additional Information:
No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: E.M. van de Putte, M.D. Ph.D., UMC Utrecht
ClinicalTrials.gov Identifier: NCT00893438     History of Changes
Other Study ID Numbers: ZonMW-56100004, ISRCTN59878666
Study First Received: May 5, 2009
Last Updated: May 21, 2013
Health Authority: The Netherlands: Institutional review board (METC University Medical Center Utrecht and CCMO University Medical Center St. Radboud Nijmegen)
The Netherlands: Julius Center for Health Sciences and Primary Care (University Medical Center Utrecht)
The Netherlands: The Netherlands Organisation for Health Research and Development (ZonMw)

Keywords provided by UMC Utrecht:
Chronic Fatigue Syndrome (CFS)
Adolescence
Cognitive behaviour therapy (CBT)
Web-based
Internet
Efficacy

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 14, 2014