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

Alan Montgomery³  Lucy Beasant²  Jenny L Donovan¹  Jonathan A Sterne¹  Zuzana Deans¹  Will Hollingworth¹  Nicola Mills¹  Esther Crawley⁴ 

[1] School of Social and Community Medicine, Canynge Hall, Whatley Road, Bristol BS8 2PS, UK;School of Social and Community Medicine, Oakfield House, Oakfield Grove, Bristol BS8 2BN, UK;University of Nottingham Clinical Trials Unit Queen’s Medical Centre, Nottingham NG7 2UH, UK;Centre for Child and Adolescent Health, School of Social and Community Medicine, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK

关键词: Myalgic encephalomyelitis;    Chronic fatigue syndrome;    Paediatrics;    Fatigue;   

Others  :  807757
DOI  :  10.1186/1745-6215-14-444

 received in 2012-12-13, accepted in 2013-12-02,  发布年份 2013

【 摘 要 】

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).

【 授权许可】

   
2013 Crawley et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Health RCoPaC: Evidence Based Guideline for the Management of CFS/ME (Chronic Fatigue Syndrome/Myalgic Encephalopathy) in Children and Young People. London; 2004.
• [2]NICE: Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (or Encephalopathy); Diagnosis and Management. London; 2007.
• [3]Jordan KM, Ayers PM, Jahn SC, Taylor KK, Huang CF, Richman J, Jason LA: Prevalence of fatigue and chronic fatigue syndrome-like illness in children and adolescents. J Chronic Fatigue Syndr 2000, 6(1):3-21.
• [4]Jones JF, Nisenbaum R, Solomon L, Reyes M, Reeves WC: Chronic fatigue syndrome and other fatiguing illnesses in adolescents: a population-based study. J Adolesc Health 2004, 35(1):34-40.
• [5]Rimes KA, Goodman R, Hotopf M, Wessely S, Meltzer H, Chalder T: Incidence, prognosis, and risk factors for fatigue and chronic fatigue syndrome in adolescents: a prospective community study. Pediatrics 2007, 119(3):e603-e609.
• [6]Crawley EM, Emond AM, Sterne JA: Unidentified chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics. BMJ Open 2011, 1(2):e000252.
• [7]Rangel L, Garralda ME, Levin M, Roberts H: The course of severe chronic fatigue syndrome in childhood. J R Soc Med 2000, 93(3):129-134.
• [8]Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G: Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. BMJ 2005, 330(7481):14.
• [9]Knoop H, Stulemeijer M, de Jong LW, Fiselier TJ, Bleijenberg G: Efficacy of cognitive behavioural therapy for adolescents with chronic fatigue syndrome: long-term follow-up of a randomised, controlled trial. Pediatrics 2008, 121(3):619-625.
• [10]Chalder T, Deary V, Husain K, Walwyn R: Family-focused cognitive behaviour therapy versus psycho-education for chronic fatigue syndrome in 11- to 18-year-olds: a randomised controlled treatment trial. Psychol Med 2010, 40(8):1269-1279.
• [11]Lloyd S, Chalder T, Rimes KA: Family-focused cognitive behaviour therapy versus psycho-education for adolescents with chronic fatigue syndrome: long-term follow-up of an RCT. Behav Res Ther 2012, 50(11):719-725.
• [12]Nijhof SL, Bleijenberg G, Uiterwaal CS, Kimpen JL, van de Putte EM: Effectiveness of Internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): a randomised controlled trial. Lancet 2012, 379(9824):1412-1418.
• [13]Crawley E, Mills N, Beasant L, Johnson D, Collin SM, Deans Z, White K, Montgomery A: The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue yndrome: feasibility randomized controlled trial (SMILE study). Trials 2013, 14:415. doi:10.1186/1745-6215-14-415 BioMed Central Full Text
• [14]Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, group C, Pragmatic Trials in Healthcare g: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008, 337:a2390.
• [15]Taves DR: Minimization: a new method of assigning patients to treatment and control groups. Clinical Pharmacol Therap 1974, 15(5):443-453.
• [16]White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O’Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M, PACE trial management group: Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011, 377(9768):823-836.
• [17]Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP: Development of a fatigue scale. J Psychosom Res 1993, 37(2):147-153.
• [18]Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30(6):473-483.
• [19]Spence SH, Barrett PM, Turner CM: Psychometric properties of the Spence children’s anxiety scale with young adolescents. J Anxiety Disord 2003, 17(6):605-625.
• [20]Jorngarden A, Wettergen L, von Essen L: Measuring health-related quality of life in adolescents and young adults: Swedish normative data for the SF-36 and the HADS, and the influence of age, gender, and method of administration. Health Qual Life Outcomes 2006, 4:91. BioMed Central Full Text
• [21]Brooks R: EuroQol: the current state of play. Health Policy 1996, 37(1):53-72.
• [22]Crawley E, Sterne JA: Association between school absence and physical function in paediatric chronic fatigue syndrome/myalgic encephalopathy. Arch Dis Child 2009, 94(10):752-756.
• [23]Reilly MC, Zbrozek AS, Dukes EM: The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993, 4(5):353-365.
• [24]Wyrwich KW, Tierney WM, Babu AN, Kroenke K, Wolinsky FD: A comparison of clinically important differences in health-related quality of life for patients with chronic lung disease, asthma, or heart disease. Health Serv Res 2005, 40(2):577-591.
• [25]Rubin DB: Multiple Imputation for Non Response in Surveys. New York: Wiley and Sons; 1987.
• [26]Brookes ST, Whitley E, Peters TJ, Mulheran PA, Egger M, Davey Smith G: Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess 2001, 5(33):1-56.
• [27]Fenwick E, Byford S: A guide to cost-effectiveness acceptability curves. Br J Psychiatry 2005, 187:106-108.
• [28]van den Hout WB: The value of productivity: human-capital versus friction-cost method. Ann Rheum Dis 2010, 69(1):i89-i91.
• [29]Coast J: Is economic evaluation in touch with society’s health values? BMJ 2004, 329(7476):1233-1236.
• [30]Donovan JL, Lane JA, Peters TJ, Brindle L, Salter E, Gillatt D, Powell P, Bollina P, Neal DE, Hamdy FC: Development of a complex intervention improved randomisation and informed consent in a randomised controlled trial. J Clin Epidemiol 2009, 62(1):29-36.
• [31]Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, Frankel S, Neal D, Hamdy F: Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ 2002, 325(7367):766-770.
• [32]Donovan J, Hamdy F, Neal D, Peters T, Oliver S, Brindle L, Jewell D, Powell P, Gillatt D, Dedman D, et al.: Prostate testing for cancer and treatment (ProtecT) feasibility study. Health Technol Assess 2003, 7(14):1-88.
• [33]Hempel S, Chambers D, Bagnall AM, Forbes C: Risk factors for chronic fatigue syndrome/myalgic encephalomyelitis: a systematic scoping review of multiple predictor studies. Psychol Med 2008, 38(7):915-926.
• [34]Harvey SB, Wadsworth M, Wessely S, Hotopf M: Etiology of chronic fatigue syndrome: testing popular hypotheses using a national birth cohort study. Psychosom Med 2008, 70(4):488-495.
• [35]Viner R, Hotopf M: Childhood predictors of self reported chronic fatigue syndrome/myalgic encephalomyelitis in adults: national birth cohort study. BMJ 2004, 329(7472):941.
• [36]Joyce J, Hotopf M, Wessely S: The prognosis of chronic fatigue and chronic fatigue syndrome: a systematic review. QJM 1997, 90(3):223-233.