Abstract
BackgroundPaediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition. The National Institute for Health and Clinical Excellence (NICE) recommends Cognitive Behavioural Therapy (CBT) as a treatment option for paediatric CFS/ME because there is good evidence that it is effective. Despite this, most young people in the UK are unable to access local specialist CBT for CFS/ME. A randomised controlled trial (RCT) showed FITNET was effective in the Netherlands but we do not know if it is effective in the National Health Service (NHS) or if it is cost-effective. This trial will investigate whether FITNET-NHS is clinically effective and cost-effective in the NHS.MethodsSeven hundred and thirty-four paediatric patients (aged 11–17 years) with CFS/ ME will be randomised (1:1) to receive either FITNET-NHS (online CBT) or Activity Management (delivered via video call). The internal pilot study will use integrated qualitative methods to examine the feasibility of recruitment and the acceptability of treatment. The full trial will assess whether FITNET-NHS is clinically effective and cost-effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS (Physical Function Scale) questionnaire. Cost-effectiveness is measured via cost-utility analysis from an NHS perspective. Secondary subgroup analysis will investigate the effectiveness of FITNET-NHS in those with co-morbid mood disorders.DiscussionIf FITNET-NHS is found to be feasible and acceptable (internal pilot) and effective and cost-effective (full trial), its provision by the NHS has the potential to deliver substantial health gains for the large number of young people suffering from CFS/ME but unable to access treatment because there is no local specialist service. This trial will provide further evidence evaluating the delivery of online CBT to young people with chronic conditions.Trial registrationISRCTN registry, registration number: ISRCTN18020851. Registered on 4 August 2016.
Highlights
Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/Myalgic encephalomyelitis (ME)) is a relatively common and disabling condition
If Fatigue In Teenagers on the internet (FITNET)-National Health Service (NHS) is found to be feasible and acceptable and effective and cost-effective, its provision by the NHS has the potential to deliver substantial health gains for the large number of young people suffering from Chronic fatigue syndrome (CFS)/ME but unable to access treatment because there is no local specialist service
This trial will provide further evidence evaluating the delivery of online Cognitive Behavioural Therapy (CBT) to young people with chronic conditions
Summary
The aims of this trial are to investigate whether Internetdelivered CBT, designed for CFS/ME, (FITNET-NHS) is effective and cost-effective compared to a ‘usual care’ comparator of Activity Management (delivered via video call) for young people with CFS/ME who do not have access to a local specialist paediatric CFS/ME service. Audio-recordings of eligibility and recruitment discussions will be analysed regularly, focussing on the interaction between recruiter and potential participant in terms of information provision, recruitment techniques, intervention preferences and trial participation decisions This will be assessed in combination with data from in-depth interviews conducted with young people and their families soon after their consultation to explore provision and acceptability of patient information, reasons for accepting or declining participation, reasons for declining treatment allocation and dropouts, prior exposure to treatments, and beliefs, expectations and preferences about treatments. We will conduct sensitivity analyses estimating the effectiveness of FITNET-NHS compared with Activity Management for the primary outcome only restricted to participants who fulfilled the CDC diagnostic criteria for CMS/ME at the time of recruitment to the trial. Participants will be made aware that if they report any serious problem outside of business hours, it may not be followed-up until business hours resume and they should contact their GP, paediatrician or emergency service
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
