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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN59878666 |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Innovatiefonds Zorgverzekeraars | OTHER |
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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).
All participants will be randomized to one of the two treatment arms:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FitNet treatment | Experimental | FitNet treatment: web-based cognitive behaviour therapy |
|
| Usual care | Active Comparator | waiting list for FitNet intervention (usual care allowed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FitNet treatment | Behavioral | web-based cognitive behavioural treatment for adolescents with CFS |
|
| Measure | Description | Time Frame |
|---|---|---|
| School presence | one year | |
| Severity of fatigue | one year | |
| Physical functioning as measured by the subscale physical functioning | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Self-rated improvement | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanne L Nijhof, MD, PhD-student | Wilhelmina Childrens' Hospital (University Medical Center Utrecht) | Principal Investigator |
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center St. Radboud | Nijmegen | 6500 HB | Netherlands | |||
| Wilhelmina Childrens' Hospital (University Medical Center Utrecht) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26510728 | Derived | 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. | |
| 21333021 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 21, 2013 | Aug 15, 2013 |
| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| Usual care | Other | Usual care treatment for adolescents with CFS |
|
| Utrecht |
| 3584 CX |
| Netherlands |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |