Efficacy of web-based cognitive behavioural treatment for adolescents with the Chronic Fatigue Syndrome
| ISRCTN | ISRCTN59878666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59878666 |
| ClinicalTrials.gov (NCT) | NCT00893438 |
| Protocol serial number | N/A |
| Sponsor | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- Submission date
- 06/07/2007
- Registration date
- 29/10/2007
- Last edited
- 08/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Elise Van de Putte
Scientific
Scientific
University Medical Center Utrecht
Postbox 85090
Utrecht
3508 AB
Netherlands
| e.vandeputte@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | FITNET |
| Study objectives | 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). |
| Ethics approval(s) | METC Utrecht gave approval on the 22nd October 2007 (ref: 07-196/K). First patient was included on 30th January 2008. |
| Health condition(s) or problem(s) studied | Chronic Fatigue Syndrome |
| Intervention | All participants will be randomised to one of the two treatment arms: 1. Intervention with web-based cognitive behavioural treatment 2. Usual care The duration of the cognitive behavioural programme is limited to 6 months. The adolescents who have been assigned to the usual care will get the opportunity to attend the programme after these 6 months. The total follow-up time is 12 months after the start of the web-based programme. The web-based programme is developed for both the adolescents and the parents. The programme 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 realised. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. School presence |
| Key secondary outcome measure(s) |
Self-rated improvement. Efficacy of the web-based programme will be determined after these 6 months. The follow-up measurement at 12 months is meant to define if the result. |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 140 |
| Key inclusion criteria | Adolescents (12 - 18 years) with Chronic Fatigue Syndrome. |
| Key exclusion criteria | 1. Score greater than or equal to 44 on the Stait-Trait Anxiety Inventory for Children 2. Score greater than or equal to 15 on the Childrens Depression Inventory 3. No availability of computer and/or internet 4. Risk of suicide 5. Mental retardation |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/04/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
