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Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study)
  1. Gary J Macfarlane1,
  2. Marcus Beasley1,
  3. Neil Scott2,
  4. Huey Chong3,
  5. Paul McNamee3,
  6. John McBeth4,
  7. Neil Basu5,
  8. Philip C Hannaford6,
  9. Gareth T Jones1,
  10. Phil Keeley7,
  11. Gordon J Prescott8,
  12. Karina Lovell9
  1. 1Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, UK
  2. 2Medical Statistics Team, University of Aberdeen, Aberdeen, UK
  3. 3Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
  4. 4Versus Arthritis Centre for Epidemiology, University of Manchester, Manchester, UK
  5. 5Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK
  6. 6Academic Primary Care, University of Aberdeen, Aberdeen, UK
  7. 7School of Nursing and Midwifery, University of Keele, Stoke-on-Trent, Staffordshire, UK
  8. 8Lancashire Clinical Trials Unit, University of Central Lancashire, Preston, UK
  9. 9Division of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK
  1. Correspondence to Professor Gary J Macfarlane, Epidemiology Group, University of Aberdeen, Aberdeen AB24 3FX, UK; g.j.macfarlane{at}abdn.ac.uk

Abstract

Objective Cognitive–behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk.

Methods A population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment.

Results 996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI −£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention.

Conclusions A short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP.

Trial registration number ClinicalTrials.gov Registry (NCT02668003).

  • fibromyalgia
  • economics
  • epidemiology

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Footnotes

  • Handling editor Josef S Smolen

  • Twitter @UAberdeenEpi, @mahkusjaybee, @hteraG_senoJ

  • Contributors GJM was CI and MB study coordinator. KL and PK were responsible for designing and overseeing the delivery of the intervention. GP was the trial statistician and designed the analysis plan, and this role was latterly taken over by NS who conducted the analysis. PM was responsible for designing the health economic analysis which was undertaken by HC. GJM drafted the manuscript with input from MB, HC, PM and NS. All authors contributed important intellectual content to trial design and execution, and commented on drafts of the manuscript.

  • Funding The study was funded by Arthritis Research UK (now Versus Arthritis) grant number: 20748. Costs for delivery of the intervention were provided by NHS Grampian, NHS Greater Glasgow and Clyde, and NHS Highland.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Ethical approval was obtained from Cornwall and Plymouth Research Ethics Committee reference 16/SW/0019.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request. There is an application process by which researchers may request to access data in this manuscript. In principle we are willing to share de-identified data.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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