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

被引：17

作者：

Baos, Sarah ^{[1
]}

Brigden, Amberly ^{[1
]}

Anderson, Emma ^{[1
]}

Hollingworth, William ^{[2
]}

Price, Simon ^{[3
]}

Mills, Nicola ^{[2
]}

Beasant, Lucy ^{[1
]}

Gaunt, Daisy ^{[2
,4
]}

Garfield, Kirsty ^{[2
,4
]}

Metcalfe, Chris ^{[2
,4
]}

Parslow, Roxanne ^{[1
]}

Downing, Harriet ^{[2
]}

Kessler, David ^{[5
]}

Macleod, John ^{[5
]}

Stallard, Paul ^{[6
]}

Knoop, Hans ^{[7
]}

Van de Putte, Elise ^{[8
]}

Nijhof, Sanne ^{[8
]}

Bleijenberg, Gijs ^{[9
]}

Crawley, Esther ^{[1
]}

机构：

[1] Univ Bristol, Bristol Med Sch Populat Hlth Sci, Ctr Child & Adolescent Hlth, Oakfield House, Bristol BS8 2BN, Avon, England

[2] Univ Bristol, Bristol Med Sch Populat Hlth Sci, Canynge Hall,39 Whatley Rd, Bristol BS8 2PS, Avon, England

[3] Univ Bristol, Comp Sci, Merchant Venturers Bldg,Woodland Rd, Bristol BS8 1UB, Avon, England

[4] Univ Bristol, Bristol Randomised Trials Collaborat, Bristol, Avon, England

[5] Bristol Med Sch Populat Hlth Sci, Oakfield House, Bristol BS8 2BN, Avon, England

[6] Univ Bath, Dept Hlth, Bath BA2 7AD, Avon, England

[7] Univ Amsterdam, AMC, Dept Med Psychol, Postbox 22660, NL-1100 DD Amsterdam, Netherlands

[8] Univ Med Ctr, Wilhelmina Childrens Hosp, Dept Paediat, Utrecht, Netherlands

[9] Radboud Univ Nijmegen, Med Ctr, Nijmegen, Netherlands

来源：

TRIALS | 2018年 / 19卷

关键词：

Paediatrics; Chronic fatigue syndrome; Myalgic encephalomyelitis; CFS/ME; CBT; E-health; Activity management; Online systems; E-therapy; E-counselling; COGNITIVE-BEHAVIOR THERAPY; SPECIALIST MEDICAL-CARE; REVISED CHILD ANXIETY; GRADED-EXERCISE; DEPRESSION; CFS/ME; INTERVENTIONS; ADOLESCENTS; IMPAIRMENT; DISEASE;

D O I：

10.1186/s13063-018-2500-3

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：12

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