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).
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. The funder of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.
We acknowledge the contribution of the trial steering committee to the successful conduct of the study. The members were Professor Ernest Choy (Cardiff University), Professor Tamar Pincus (Royal Holloway, University of London) and Gordon Taylor (Bath University). We thank Brian Taylor and Mark Forrest from the Centre for Healthcare Randomised Trials (CHaRT) at the University of Aberdeen for their technical assistance and Professor Graeme MacLennan, Director of CHaRT, for methodological input. Professor John Norrie (originally University of Aberdeen now University of Edinburgh) and Dr. Majid Artus (originally Keele University, now the Osmaston surgery, Derbyshire) were study investigators at the time of grant award but subsequently left the study. We thank Kathy Longley (a representative of Fibromyalgia Action UK) for her input to the grant application and the project as well as from members of the public on the University of Aberdeen College of Life Sciences and Medicine Research Interest Group. The prioritisation of
“Prevention of chronic pain” arose from a 2012 meeting of the Arthritis Research UK Clinical Study Group in Pain to which patients contributed.
Data Availability StatementData 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.
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