Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial

Abstract

BackgroundPaediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition. The National Institute for Health and Clinical Excellence (NICE) recommends Cognitive Behavioural Therapy (CBT) as a treatment option for paediatric CFS/ME because there is good evidence that it is effective. Despite this, most young people in the UK are unable to access local specialist CBT for CFS/ME. A randomised controlled trial (RCT) showed FITNET was effective in the Netherlands but we do not know if it is effective in the National Health Service (NHS) or if it is cost-effective. This trial will investigate whether FITNET-NHS is clinically effective and cost-effective in the NHS.MethodsSeven hundred and thirty-four paediatric patients (aged 11–17 years) with CFS/ ME will be randomised (1:1) to receive either FITNET-NHS (online CBT) or Activity Management (delivered via 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 via cost-utility analysis from an NHS perspective. Secondary subgroup analysis will investigate the effectiveness of FITNET-NHS in those with co-morbid mood disorders.DiscussionIf FITNET-NHS is found to be feasible and acceptable (internal pilot) and effective and cost-effective (full trial), its provision by 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. This trial will provide further evidence evaluating the delivery of online CBT to young people with chronic conditions.Trial registrationISRCTN registry, registration number: ISRCTN18020851. Registered on 4 August 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2500-3) contains supplementary material, which is available to authorized users.

Defining the minimally clinically important difference of the SF-36 physical function subscale for paediatric CFS/ME: triangulation using three different methods

“…However, the SF-36-PFS in an important measure as young people with CFS/ME feel that a lack of social participation and low mood is secondary to the symptoms and physical disability they experience [ 33 , 34 ]. Further, it has been used in studies for paediatric CFS/ME in the UK, Australia and the Netherlands [ 14 , 17 , 35 – 37 ].…”

“…The SF-36 physical function sub-scale (SF-36-PFS) consists of ten items and is used to measure change in disability in many chronic illnesses including Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) [ 10 – 13 ]. An MCID defined as 0.3/0.5 SD of the SF-36-PFS, typically equating to 8 to 10 points has been used in adult and paediatric CFS/ME [ 14 – 17 ], but it is unclear if this is appropriate and clinically relevant for patients. In other conditions, the Delphi method has suggested an MCID of 10 for asthma and heart disease [ 18 ], and 5 for Chronic Obstructive Pulmonary Disease in adults [ 18 ].…”

Recruiting Adolescents With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis to Internet-Delivered Therapy: Internal Pilot Within a Randomized Controlled Trial

“…A detailed description of the study methods is presented elsewhere [ 6 ]. In brief, all referrals from GPs were screened by administrative staff, and those potentially eligible for FITNET-NHS were contacted by research nurses.…”

The Importance of Accurate Diagnosis of ME/CFS in Children and Adolescents: A Commentary

“…These young patients will most likely trust a diagnosis given by a physician and they are likely to follow recommended care, which might include being offered psycho-behavioral therapies like CBT or graded exercise (which are recommended based on clinical trials that apply the same loose diagnostic tools that generate inflated prevalence estimates). The Bristol ALSPAC research team, that report prevalence rates as high as 2%, are active in testing CBT and GET on children and teenagers with suspected ME/CFS (39, 40). There is a concern that psychological therapies may help teenagers that perhaps have undiagnosed psychological complaints or general fatigue complaints, who are inappropriately included into clinical trials.…”