Authors' objectives: AIMS: This is a large trial to test whether FITNET-NHS, a treatment delivered via the internet, is effective and value for money for children with Chronic Fatigue Syndrome or myalgic encephalomyelitis (CFS/ME). Children with CFS/ME have fatigue that stops them going to school or doing other activities for more than 3 months. In England, up to 2 in a 100 children have CFS/ME and 1% of secondary school children miss a day a week or more because of it. Most children with CFS/ME will recover if they receive specialist treatment. Specialist treatment recommended by the National Institute of health and Clinical Excellence (NICE) includes Cognitive Behaviour Therapy (CBT), Graded Exercise Therapy or Activity Management. However, approximately 90% of children in the UK cannot have treatment because they live too far away from specialist services. For these children, probably only 8% will recover at 6 months. One solution is for these children to receive specialist CBT for CFS/ME using the internet at home. FITNET-NHS provides internet based CBT for CFS/ME and has been shown to be effective in the Netherlands with 63% of children recovering at 6 months. We cannot use this treatment in the NHS until we know if children find it acceptable, and we know if it is effective and good value for money. We also need to know if FITNET-NHS will work in children with both CFS/ME and mood problems (one third of children with CFS/ME). In this large trial, children will be randomised to receive either: Activity Management or FITNET-NHS. Those who get Activity Management will receive information on managing activities and sleep. They will have three Skype calls (one assessment and two follow up) with CFS specialist occupational therapist (OT)s to understand and provide advice on sleep and activity. The specialist OT will hand over care to the local GP or paediatrician but will provide support to them with up to three phone calls. Those who get FITNET-NHS (and their parents) will be given information and then work through 21 interactive CBT modules. Children will be asked to do homework (answer questions and complete diaries). CBT-trained therapists will make weekly appointments with children and their parents to review homework and support behaviour change. We want to recruit 734 children over 42 months to have results on 660 (330 in each arm). We will test whether it is possible to recruit this number in our internal pilot study (12 months). We will interview children, their parents and clinicians and use the results to make changes to the trial. The most important outcome to children is disability. We will test whether FITNET-NHS is effective at reducing disability at 6 months. We will also measure fatigue, pain, quality of life, anxiety and depression at 3, 6, 9 and 12 months as well as information on how much the NHS and families spend on treatment and whether parents return to work. Both Patients and the Public (healthy teenagers) have helped us design this study. Patient involvement is important to us and this trial will have a patient advisory group to help us run the trial. It will be important that patients, clinicians, those that fund health care and researchers know about the results of this study. We will use the charities and the press (Science Media Centre) to help us inform patients. We will make sure paediatricians and researchers know the results by writing papers and presenting at clinical and scientific meetings and conferences.

Project Status: Ongoing

URL for project: http://www.nets.nihr.ac.uk/projects/hta/14192109

Anticipated Publish Date: 2021

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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