1 Nov 2016 to 30 Oct 2021
1 Nov 2016 to 30 Oct 2021
Paediatric chronic fatigue syndrome/myalgic encephalitis (CFS/ME) is common in the UK, with estimated prevalence between 1 and 2.4%. CFS/ME is defined as disrupting and persistent generalised fatigue, diagnosed after routine investigations have failed to identify an alternative explanation for the fatigue. Young people with CFS/ME are disabled and 30% of them experience co-morbid anxiety and depression. They use significant healthcare resources and put substantial burden on their families.
The National Institute for Health and Clinical Excellence (NICE) recommends that young people with CFS/ME are offered either:
There is good evidence from randomised controlled trials (RCTs) that CBT is effective for paediatric CFS/ME. However, most young people in the UK do not have access to a local NHS specialist service offering CBT for CFS/ME.
The FITNET (Fatigue In Teenagers on the interNET) trial carried out in the Netherlands recruited 135 participants between 2008 and 2010. It showed that Internet-delivered CBT was effective compared to usual care at 6 months. Young people were more likely to have:
None of the published paediatric trials reported on cost-effectiveness and have either excluded young people with co-morbid mood problems or have not been powered to investigate this group.
To investigate whether Internet-delivered CBT, specifically designed for CFS/ME, (FITNET-NHS) is effective and cost-effective compared to a ‘usual care’ comparator of Activity Management (delivered by video call) for young people with CFS/ME who do not have access to a local specialist paediatric CFS/ME service.
314 paediatric patients (aged 11 to 17 years) with CFS/ME will be randomised (1:1) to receive either FITNET-NHS (online CBT) or Activity Management (by video call).
The internal pilot study will use integrated qualitative methods to examine the feasibility of recruitment and the acceptability of treatment.
The full trial will assess whether FITNET-NHS is clinically effective and cost-effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS (Physical Function Scale) questionnaire.
Cost-effectiveness is measured by cost-utility analysis from an NHS perspective. Secondary subgroup analysis will investigate the effectiveness of FITNET-NHS in those with co-morbid mood disorders.
FITNET is an Internet-delivered CBT package created for paediatric CFS/ME in the Netherlands. The programme has 19 psycho-educational and CBT chapters for young people and a parallel programme for their parents. Participants and their parents have separate accounts and log-ins.
The psycho-educational chapters include information on:
The CBT section is activated by a clinical psychologist once the young person/parent has completed the psycho-educational chapters.
Parental chapters explore and address parents’ beliefs and behaviours towards their child with CFS/ME, focussing on their role as carers.
In participants younger than 15 years, parents/carers are supported to act as a coach. In those older than 15 years, parents/carers are encouraged to step back and support their child taking responsibility for their treatment.
The CBT chapters focus on cognitive behavioural strategies with instructions on exercises for identifying, challenging and changing cognitive processes that contribute to CFS/ME and increasing self-efficacy with respect to fatigue, the ability to be active and work towards recovery.
There are two protocols depending on the pattern of activity levels if participants are:
Chapters 1 to 4 introduce CBT and explain the role of therapists, present CFS/ME as a multifactorial model with predisposing, precipitating and maintaining factors and discuss the role of the family.
Chapter 4 focus on treatment goals including the goal of full-time education and chapter 5 focusses on regulation of sleep-wake patterns. Chapters 6 to 19 focus on cognitive behavioural strategies with instructions on exercises on identifying, challenging and changing cognitive processes that contribute to CFS/ME. While participants are able to complete the chapters at their own pace, they are encouraged to work on, and complete, chapters before the next e-consultation.
Activity Management by video call will be delivered by specialist therapists (occupational therapists, physiotherapists, psychologists, physicians and nurses). Participants will have three to six video appointments (one assessment and up to five follow-ups). Parent/carer attendance is optional.
During the assessment, the therapists will:
Participants will receive information on CFS/ME, activity management, sleep and symptom management.
The first follow-up video call will be arranged 2 to 6 weeks after assessment depending on participant preference. If the patient still requires clinical care further follow-up video calls will be organised from 2 to 6 weeks later. During the follow-up video calls (around 60 minutes each) the therapist will review activity and sleep and help participants to problem-solve. Participants will be encouraged to increase activity between sessions.
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 by 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.