title: Comparing specialist medical care with specialist medical care plus the Lightning Process for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial).
abstract: BACKGROUND
  Chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and potentially serious condition with a limited evidence base for treatment. Specialist treatment for paediatric CFS/ME uses interventions recommended by National Institute for Health and Clinical Excellence (NICE) including cognitive behavioural therapy, graded exercise therapy and activity management. The Lightning Process (LP) is a trademarked intervention derived from osteopathy, life-coaching and neuro-linguistic programming, delivered over three consecutive days as group sessions. Although over 250 children with CFS/ME attend LP courses each year, there are no reported studies on the effectiveness or cost-effectiveness.
  
  
  METHODS
  This pragmatic randomised controlled trial is set within a specialist paediatric CFS/ME service in the south west of England. Children and young people with CFS/ME (n = 80 to 112), aged 12 to 18 years old will be randomised to specialist medical care (SMC) or SMC plus the LP. The primary outcome will be physical function (SF-36 physical function short form) and fatigue (Chalder Fatigue Scale).
  
  
  CONCLUSIONS
  This study will tell us whether adding the LP to SMC is effective and cost-effective compared to SMC alone. This study will also provide detailed information on the implementation of the LP and SMC.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN81456207 (31 July 2012).
authors.affiliation: Centre for Child and Adolescent Health, School of Social and Community Medicine, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK. Esther.crawley@bristol.ac.uk.
authors.forename: Esther
authors.initials: E
authors.lastname: Crawley
authors.forename: Nicola
authors.initials: N
authors.lastname: Mills
authors.forename: Will
authors.initials: W
authors.lastname: Hollingworth
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Deans
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Sterne
authors.forename: Jenny L
authors.initials: JL
authors.lastname: Donovan
authors.forename: Lucy
authors.initials: L
authors.lastname: Beasant
authors.forename: Alan
authors.initials: A
authors.lastname: Montgomery
mesh_terms: D000293:Adolescent; D002648:Child; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D004739:England; D015673:Fatigue Syndrome, Chronic / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D011615:Psychotherapy, Group / Q000191:economics; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome