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Investigating the effectiveness of FITNET-NHS compared to Activity Management

This project will investigate whether FITNET-NHS (online CBT) is clinically effective and cost-effective in the NHS.

Project status

In progress

Duration

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:

  • Cognitive Behavioural Therapy (CBT) - strategies to identify, challenge and change fatigue-related cognitive processes and gradually resume activities
  • Graded Exercise Therapy (GET) - stabilises physical activity levels, before gradually increasing at a manageable rate
  • Activity Management - goal-oriented and person-centred approach which establishes a baseline for all activity, which is then increased

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.

FITNET trial

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:

  • recovered
  • defined as no longer severely fatigued or physically impaired
  • attended school
  • perceived themselves as completely/nearly completely recovered (63% versus 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 or have not been powered to investigate this group.

Current study

Aims

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.

Methods

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.

Interventions

FITNET-NHS (intervention)

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:

  • CFS/ME
  • the causes of CFS/ME
  • the relationship between CFS/ME, anxiety, depression and other illnesses
  • how diagnosis is confirmed
  • treatment for CFS/ME
  • how to explain CFS/ME to friends
  • what the future (without CFS/ME) is likely to look like

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:

  • identified as being relatively active with a varying level of activity, they first find their baseline before increasing slowly
  • defined as being ‘low active’ with little variation in activity, they immediately start with increasing activity

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 (comparator)

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:

  • discuss the different types of activity – including cognitive activity (high concentration and low concentration) – which vary according to age
  • carry out a detailed assessment of the individual’s current activity levels
  • collaboratively agree a ‘baseline’, which is the average level of activity

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.

Research team

Chief Investigator

Co-Investigators

Project partners

Funder

Expected outputs

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.

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