FITNET-NHS: How effective is FITNET-NHS for children and young adults
Research type
Research Study
Full title
Investigating the effectiveness and cost-effectiveness of using FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME) in the United Kingdom: A randomised controlled trial (FITNET-NHS)
IRAS ID
211202
Contact name
Esther Crawley
Contact email
ISRCTN Number
ISRCTN18020851
Duration of Study in the UK
5 years, 6 months, 1 days
Research summary
This large randomised controlled trial will investigate the relative clinical and cost-effectiveness of the FITNET-NHS intervention compared with Activity Management, among children with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME) who do not have a local NHS specialist CFS/ME service. The FITNET-NHS intervention delivers specialist cognitive behavioural therapy for CFS/ME via the internet. Participants and their parents work through 21 modules and have e-consultations with therapists. Activity Management is used as the comparator in this study as it is recommended by the National Institute of Health & Clinical Excellence (NICE) and is currently the best alternative for children in regions without a local specialist CFS/ME service. Activity Management will be delivered by specialist occupational therapists from Bath Specialist CFS/ME Service via video calls (e.g. Skype). Children will be referred from primary care throughout the UK to the Bath Specialist CFS/ME Service where potentially eligible children will be identified and invited to eligibility screening prior to randomisation.
The first phase of the trial is an internal pilot study which will use integrated qualitative methods to examine the acceptability of the treatment arms and the feasibility of recruitment. The full study will assess whether FITNET-NHS is clinically effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS questionnaire. The trial is powered to perform a secondary subgroup analysis investigating the effectiveness of FITNET-NHS in those with co-morbid mood disorders. The full study will also assess whether FITNET-NHS is cost-effective in a cost utility analyses from NHS and social perspective. If FITNET-NHS is effective and cost effective, its provision by the NHS has the potential to deliver substantial health gains for the large number of children suffering from CFS/ME but unable to access treatment because there is no local specialist service.
REC name
South West - Frenchay Research Ethics Committee
REC reference
16/SW/0268
Date of REC Opinion
10 Oct 2016
REC opinion
Further Information Favourable Opinion