Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With Chronic Fatigue Syndrome (FitNet)
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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 |
- 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 ]
- 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:
|
|
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:
- 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.
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Netherlands | |
| University Medical Center St. Radboud | |
| Nijmegen, Netherlands, 6500 HB | |
| Wilhelmina Childrens' Hospital (University Medical Center Utrecht) | |
| Utrecht, Netherlands, 3584 CX | |
| 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 May 23, 2013