Title: Investigating the effectiveness and cost effectiveness of using FITNET to treat paediatric CFS/ME in the UK
Funder: Department of Health and Social Care

Abstract: EXPERT SUMMARY: This large randomised trial will investigate the relative clinical- and cost-effectiveness of the FITNET-NHS (specialist CBT for paediatric CFS/ME delivered on-line) compared with Activity Management, A Dutch study showed FITNET to be effective: 63% of children in the FITNET arm recovered at 6 months compared with 8% in the standard medical care arm. Before implementation in the UK, we need to know if FITNET-NHS is effective and cost-effective compared with Activity Management. An internal pilot study with integrated qualitative methods will test the feasibility of recruitment and acceptability of interventions. DESIGN: Randomised trial comparing FITNET-NHS with Activity Management. SETTING: Primary care in regions with no specialist paediatric CFS/ME service (90% of UK). LITERATURE REVIEW: We have conducted two published systematic reviews to investigate treatment outcomes, and have completed one unpublished systematic review investigating recovery in paediatric CFS/ME. TARGET POPULATION: Children (age 11 to 17) with CFS/ME HEALTH TECHNOLOGIES: The FITNET-NHS intervention delivers specialist cognitive behavioural therapy (CBT) for CFS/ME via the internet. Participants and their parents work through 21 interactive modules and have weekly e-consultations with therapists. ACTIVITY MANAGEMENT: Behavioural intervention delivered by specialist occupational therapists who provide 6 Skype calls for participants and then support local providers delivering care (maximum 3 phone calls) PRIMARY OUTCOME MEASURE: SF-36-physical function subscale (PFS) at 6 months. SECONDARY OUTCOMES: Fatigue (Chalder scale & Check list Individual strength (CIS, fatigue severity subscale)); school attendance; mood (Revised Children’s Anxiety and Depression Scale (RCADS)); Pain visual analogue scale; Clinical Global Impression Scale; Quality adjusted life years (EQ-5D-5L) at 3, 6 and 12 months and SF36-PFS at 3 and 12 months. All measures are used in UK services and tested in trials. MEASUREMENT OF COSTS: FITNET was effective in the Netherlands but we do not know if it is cost effective. We will investigate societal cost effectiveness of FITNET compared to activity management. Parent-completed questionnaires at baseline and 3, 6, 9 and 12 months will measure productivity (adapted 4 item Work Productivity and Activity Impairment Questionnaire General Health V2.0 [WPAI:GH]), out of pocket expenses and child's health service use. We will collect primary care data to determine primary care use and link to administrative data (HES and MHLDDS) for secondary care and longer term outcomes. SAMPLE SIZE: We will randomise 734 and analyse 660 children (attrition ~10%), giving 97% power to detect a 0.35SD difference on SF36-PFS. A secondary analysis of effectiveness in children with co-morbid mood disorders will have 80% power to detect a 0.4SD difference. PROJECT TIMETABLE: Set up (M1-6): FITNET migration and adaptation to FITNET-NHS. Internal pilot study (M7-18): recruit 286 participants. Integrated qualitative methods used to improve recruitment and assess acceptability. Full trial recruitment (M 19-48): Recruit 1050 participants. Follow up (M 49-60). Analyses and write HTA report (M 61-66) EXPERTISE: FITNET developers/investigators; experts in: paediatric CFS/ME; CBT; health economics; statistics and methodology, primary care, recruiting from primary care, linking to routine NHS data; patient expertise.

Lay abstract: 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 six Skype calls (one assessment and five 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.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: DISPUTED AETIOLOGY AND OTHER