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)

Trials. 2013 Dec 26;14:444. doi: 10.1186/1745-6215-14-444.

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).

Discussion: 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.

Trial registration: Current Controlled Trials ISRCTN81456207 (31 July 2012).

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Child
  • Clinical Protocols
  • Combined Modality Therapy
  • Cost-Benefit Analysis
  • England
  • Fatigue Syndrome, Chronic / diagnosis
  • Fatigue Syndrome, Chronic / economics
  • Fatigue Syndrome, Chronic / physiopathology
  • Fatigue Syndrome, Chronic / psychology
  • Fatigue Syndrome, Chronic / therapy*
  • Female
  • Health Care Costs
  • Humans
  • Male
  • Psychotherapy, Group* / economics
  • Research Design*
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome

Associated data

  • ISRCTN/ISRCTN81456207