Chronic Fatigue SyndromeFitNetNCT00893438
Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With Chronic Fatigue Syndrome
A study testing FitNet treatment in people with Chronic Fatigue Syndrome, run by UMC Utrecht at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- FitNet treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2008to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents (12 - 18 years) with Chronic Fatigue Syndrome
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Medical Center St. Radboud
Nijmegen, 6500 HB
Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Utrecht, 3584 CX
About this study
Official title: Fatigue in Teenagers on the Internet (FitNet); Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With the 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).
Read the 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.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- FitNet treatment, Usual care
- Keywords
- Chronic Fatigue Syndrome (CFS), Adolescence, Cognitive behaviour therapy (CBT), Web-based, Internet, Efficacy
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitNet treatmentBehavioural
Also called CBT, Internet treatment
web-based cognitive behavioural treatment for adolescents with CFS
Usual careOther
Usual care treatment for adolescents with CFS
| Study group | Role | What they receive |
|---|---|---|
| FitNet treatment | Experimental | FitNet treatment: web-based cognitive behaviour therapy Receives: Behavioral: FitNet treatment |
| Usual care | Active comparator | waiting list for FitNet intervention (usual care allowed) Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
School presence
Measured: one year
Severity of fatigue
Measured: one year
Physical functioning as measured by the subscale physical functioning
Measured: one year
Secondary outcomes (1)
Self-rated improvement
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startJan 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Innovatiefonds Zorgverzekeraars
- Responsible party
- Principal investigator, E.M. van de Putte, UMC Utrecht
- Investigators
- Sanne L Nijhof, MD, PhD-student, Principal investigator, Wilhelmina Childrens' Hospital (University Medical Center Utrecht)Elise M van de Putte, MD, PhD, Study director, Wilhelmina Childrens' Hospital (University Medical Center Utrecht)Gijs Bleijenberg, Prof, Study director, University Medical Center St. RadboudCuno SP Uiterwaal, MD, PHD, Study director, Julius Center for Health Sciences and Primary Care, University Medical Center UtrechtJan JL Kimpen, Prof., Study director, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893438
- Sponsor's protocol ID
- ZonMW-56100004
- Other IDs
- ISRCTN59878666
- Acronym
- FitNet
- Status last verified
- May 2013
- First submitted
- 5 May 2009
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26510728Nijhof 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.
PubMed 21333021
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Teenagers on the Internet (FitNet); Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With the Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT00893438
- Acronym / sponsor ID
- FitNet / ZonMW-56100004
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic Fatigue Syndrome (CFS), Adolescence, Cognitive behaviour therapy (CBT), Web-based, Internet, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Innovatiefonds Zorgverzekeraars
- Study start
- Jan 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FitNet treatment | Experimental | Behavioral: FitNet treatmentFitNet treatment: web-based cognitive behaviour therapy |
| Usual care | Active comparator | Other: Usual carewaiting list for FitNet intervention (usual care allowed) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents (12 - 18 years) with Chronic Fatigue Syndrome
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitNet treatmentAlso: CBT, Internet treatmentweb-based cognitive behavioural treatment for adolescents with CFS | Behavioural | FitNet treatment |
| Usual careUsual care treatment for adolescents with CFS | Other | Usual care |
Primary outcome
School presence
Time frame: one year
Severity of fatigue
Time frame: one year
Physical functioning as measured by the subscale physical functioning
Time frame: one year
1 secondary outcome
Self-rated improvement
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
- Derived from this study: PubMed 26510728Collin 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.
- Derived from this study: PubMed 21333021Nijhof 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanne L Nijhof, MD, PhD-student principal investigator
Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Elise M van de Putte, MD, PhD study director
Wilhelmina Childrens' Hospital (University Medical Center Utrecht)
Gijs Bleijenberg, Prof study director
University Medical Center St. Radboud
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitNet treatment in people with Chronic Fatigue Syndrome, run by UMC Utrecht at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School presence (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00893438, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2013; AzTrials last refreshed its copy on 7 Nov 2026.