Young people with CFS/ME should be offered referral to a specialist paediatric CFS/ME service [
4]. However, most young people in the UK do not have access, or must travel very long distances to an NHS specialist service offering NICE-recommended treatments including Activity Management or CBT for CFS/ME. There is an evidence base for the using CBT to treat paediatric CFS/ME. However, none of the published paediatric trials have reported on cost-effectiveness. Although Internet-delivered CBT appears to be potentially useful, further evaluation is required before it is used within the NHS [
44].
Strengths and limitations
This will be the largest RCT conducted in paediatric CFS/ME. It is designed to investigate the effectiveness and cost-effectiveness of using FITNET-NHS, delivering online CBT, compared to Activity Management delivered via video calls, to treat paediatric CFS/ME in the UK. If effectiveness and cost-effectiveness are demonstrated for either arm, 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. If it is feasible this method could be used for other long-term conditions where young people do not have local specialist services. Results from the qualitative methods will tell us about patient experiences of the intervention content and mode of delivery, how to improve these types of interventions and how to deliver treatment from a single centre in the UK. Results will be disseminated as widely as possible including: open-access journals, conferences and public events. This is likely to benefit young people from other conditions, their families, clinicians and the NHS.
There is currently limited evidence of treatment effect in children with co-morbid mood disorders [
45]. Most, but not all [
46], studies in adults suggest that CBT is less effective in patients with co-morbid depression [
47‐
49]. Anxiety and depression is common for young people with CFS/ME [
8,
50,
51]. FITNET-NHS is designed to treat young people with co-morbid mood disorders as well as CFS/ME and this trial is powered to test whether the effects of FITNET-NHS differ in this subgroup of young people.
Our trial design includes usual care delivered by a specialist service. This is because it was felt to be unethical to offer no treatment to children in the control arm, though for many children in the UK ‘usual care’ is no treatment.
As Activity Management and CBT are behavioural interventions it is not feasible to blind participants or clinicians to allocation. However, the research team have worked to ensure the information sheets present the two treatments in a balanced way, and recruiters have had training to try and encourage participant equipoise. The analyses will be conducted by a researcher blinded to treatment allocation. As we are investigating CFS/ME, the outcomes are patient-reported outcomes. These outcomes are consistent with illness domains that are the most important to patients. The outcomes at follow-up are not reported to clinicians to reduce performance bias.
There is potential for contamination between interventions because of contact between therapists of two treatment arms (working in the same treatment centre); however, both treatment arms are protocolised and adherence will be checked.
If differences in effectiveness are found between the treatments, further research will be required to explore mechanisms of effectiveness.