Using the internet to treat paediatric Chronic Fatigue Syndrome.
Paediatric Chronic Fatigue Syndrome is relatively common and disabling. Specialist treatment is effective however approximately 90% of children in the UK, do not have access to a local specialist CFS/ME service. FITNET is an internet delivered treatment that has been shown to be highly effective in the Netherlands (Lancet 2011). In this study, 63% of children recovered at 6 months compared to 8% in the control group. Before implementation in the UK, we need to know whether FITNET is effective or cost effective in the NHS.
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. An internal pilot study with integrated qualitative methods will test the feasibility of recruitment and acceptability of interventions.SETTING: Primary care in regions with no specialist paediatric CFS/ME service (90% of UK).TARGET POPULATION: Children (age 11 to 17) with CFS/METREATMENT: FITNET-NHS intervention is 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 3 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-PFS6 at 3 and 12 months. All measures are used in UK services and tested in trials.MEASUREMENT OF COSTS: 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.
FITNET was highly effective in the Netherlands. It has the potential of being highly effective in the UK. This HTA funded trial will test the effectiveness and cost-effectiveness for children with CFS/ME throughout the UK.
This trial is important for GPs throughout the UK as for the first time, they and their patients will have access to specialist CFS/ME treatment.