Maintaining Musculoskeletal Health Using a Behavioural Therapy Approach: A Population-Based Randomised Controlled Trial (The MAmMOTH Study)

Background: Cognitive Behaviour Therapy (CBT) has been shown to be effective in the management of Chronic Widespread Pain (CWP). There have been no studies on whether a short course of telephone CBT (tCBT) can prevent onset among adults at high risk of CWP. Methods: A population-based randomised controlled prevention trial, with recruitment through general practices in three areas of the UK. A mailed screening questionnaire identified adults at high risk of CWP.  Participants received either usual care (UC) or a short course of tCBT.  The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EQ-5D-5L) used as part of a health economic assessment. Findings: 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 female. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% v. 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, 0.040)); and had  0.023 (95% CI 0.007, 0.039) more QALYs at an additional cost of £42.30 (95% CI −451.19, 597.90), yielding an incremental cost effectiveness ratio of £1,828. Most secondary outcomes showed significant benefit for the intervention. Interpretation: A short course of tCBT does not prevent the onset of CWP in adults at high risk. However, it did improve quality of life and was cost-effective.  A low-cost short duration intervention benefits not only persons with CWP but persons at risk of its development. Trial Registration: Trial registration was at clinicaltrials.gov (NCT02668003). Funding: Arthritis Research UK with funding of the intervention from NHS Grampian, NHS Greater Glasgow and Clyde, and NHS Highland Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: Ethical approval was obtained from Cornwall and Plymouth Research Ethics Committee Reference 16/SW/0019.