Countrygirl
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The proposed tiral is now published on Feb 22nd in Pubmed dhttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2500-3
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
- Sarah Baos,
- Amberly Brigden,
- Emma AndersonEmail author,
- William Hollingworth,
- Simon Price,
- Nicola Mills,
- Lucy Beasant,
- Daisy Gaunt,
- Kirsty Garfield,
- Chris Metcalfe,
- Roxanne Parslow,
- Harriet Downing,
- David Kessler,
- John Macleod,
- Paul Stallard,
- Hans Knoop,
- Elise Van de Putte,
- Sanne Nijhof,
- Gijs Bleijenberg and
- Esther Crawley
https://doi.org/10.1186/s13063-018-2500-3
© The Author(s). 2018
Received: 26 January 2017
Accepted: 7 December 2017
Published: 22 February 2018
Abstract
Background
Paediatric 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.
Methods
Seven 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
Discussion
If 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.
Background
Paediatric chronic fatigue syndrome/myalgic encephalitis (CFS/ME) is common in the UK, with estimated prevalence between 1 and 2.4% [1, 2]. CFS/ME is defined as disrupting and persistent generalised fatigue, diagnosed after routine investigations have failed to identify an alternative explanation for the fatigue [3, 4]. Young people with CFS/ME are disabled [5, 6] and 30% of them experience co-morbid anxiety and depression [7, 8]. They use significant healthcare resources [9] and put substantial burden on their families [10].
The National Institute for Health and Clinical Excellence (NICE) recommends that young people with CFS/ME are offered either Cognitive Behavioural Therapy (CBT, which focusses on strategies to identify, challenge and change fatigue-related cognitive processes and gradually resume activities), Graded Exercise Therapy (GET, which stabilises physical activity levels, before gradually increasing at a manageable rate) or Activity Management (a goal-oriented and person-centred approach which establishes a baseline for all activity, which is then increased) [4, 11]. CBT and GET are moderately effective in adults with CFS/ME [12, 13, 14, 15]. There is good evidence from randomised controlled trials (RCTs) that CBT is effective for paediatric CFS/ME [16, 17, 18, 19]. However, most young people in the UK do not have access to a local NHS specialist service offering CBT for CFS/ME. Some children in the UK are able to access treatment (GET or Activity Management) delivered as one face-to-face assessment with Skype follow-up appointments.
The FITNET (Fatigue In Teenagers on the interNET) trial carried out in the Netherlands [16] recruited 135 participants between 2008 and 2010, and showed that Internet-delivered CBT was effective compared to usual care at 6 months. Young people were more likely to have recovered; defined as no longer severely fatigued or physically impaired; attending school; and they perceived themselves as completely/nearly completely recovered (63% vs. 8%, relative risk 8.0, 95% CI 3.4–19.0; p < 0.0001). None of the published paediatric trials reported on cost-effectiveness and have either excluded young people with co-morbid mood problems [17] or have not been powered to investigate this group [16, 18, 19].
Activity Management involves Increasing activity by 10–20% each week [4, 16]............(sounds like GET on speed
)Methods
Discussion
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, 48, 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.
Trial status
Opened to recruitment November 2016. Recruitment is ongoing into 2020. For details see: www.bristol.ac.uk/fitnet-nhs/.
