| Title |
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
|
|---|---|
| Published in |
Trials, February 2018
|
| DOI | 10.1186/s13063-018-2500-3 |
| Pubmed ID | |
| Authors |
Sarah Baos, Amberly Brigden, Emma Anderson, 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, Esther Crawley |
| Abstract |
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. 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. 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. ISRCTN registry, registration number: ISRCTN18020851 . Registered on 4 August 2016. |
X Demographics
The data shown below were collected from the profiles of 14 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United Kingdom | 6 | 43% |
| United States | 1 | 7% |
| Unknown | 7 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 11 | 79% |
| Practitioners (doctors, other healthcare professionals) | 2 | 14% |
| Scientists | 1 | 7% |
Mendeley readers
The data shown below were compiled from readership statistics for 149 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 149 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 21 | 14% |
| Student > Bachelor | 18 | 12% |
| Student > Ph. D. Student | 13 | 9% |
| Researcher | 12 | 8% |
| Student > Doctoral Student | 8 | 5% |
| Other | 19 | 13% |
| Unknown | 58 | 39% |
| Readers by discipline | Count | As % |
|---|---|---|
| Nursing and Health Professions | 21 | 14% |
| Psychology | 21 | 14% |
| Medicine and Dentistry | 20 | 13% |
| Sports and Recreations | 4 | 3% |
| Social Sciences | 3 | 2% |
| Other | 14 | 9% |
| Unknown | 66 | 44% |