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Smoking Cessation Intervention for severe Mental Ill Health Trial (SCIMITAR): a pilot randomised control trial

The SCIMITAR pilot trial compared the clinical and cost-effectiveness of a bespoke smoking cessation intervention with usual general practitioner (GP) care for people with severe mental illness.  We found a positive trend in relation to verified smoking cessation and that recruitment and data collection for a full trial was possible. 

Why did we do this research?

People with Severe Mental Health are twice as likely to smoke than the general population but are less likely to receive help to quit, contributing to poor physical health in this population and  increasing their risk of early death. The services currently available to aid quitting are those which are widely available to the general population but may not be suitable or effective in patients with severe mental illness.

This study was conducted to test recruitment, retention, and randomisation in people with severe mental ill health.

What did we do?

We conducted a pragmatic, two-arm, parallel-group, pilot randomised controlled trial with 97 participants: 51 were allocated to usual GP care and 46 assigned to the bespoke smoking cessation intervention group. 

Who was involved?

We worked with four mental health trusts and 45 GP surgeries across England. 

What did we find?

The main findings were that smoking cessation can be achieved among people with severe mental ill health and that use of a bespoke smoking cessation intervention might increase engagement with services and boost the chances of sustained quitting. The observed odds of successful quitting at 12 months were almost three times higher among individuals assigned to a bespoke smoking cessation intervention compared with people allocated to receive usual care. This estimate is in line with previous research, but caution should be taken when interpreting these results because they are based on pilot trial data. The pilot economic analysis demonstrated that it was feasible to carry out a full economic analysis.

We also found it is possible to recruit people with severe mental illness from primary and secondary care to a trial of a smoking cessation intervention based around behavioural support and medication. It is feasible to biochemically verify smoking cessation and to obtain follow-up in a substantial proportion of participants. 

What happens next?

This was a pilot study, conducted in preparation of a larger study. Further research is needed to establish the clinical effectiveness of the bespoke smoking cessation intervention and whether or not this represents good value for money to the NHS. The SCIMITAR pilot trial  has formed a template for the fully powered SCIMITAR+ trial.  

Publications

• Peckham E, Man M, Mitchell N, Li J, Becque T, Knowles S, et al. Smoking Cessation Intervention for severe Mental Ill Health Trial (SCIMITAR): a pilot randomised control trial of the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation service. Health Technol Assess 2015;19(25) https://www.journalslibrary.nihr.ac.uk/hta/hta19250/#/full-report
• Gilbody S, Peckham E, Man MS, Mitchell N, Li J, Becque T, Hewitt C, Knowles S, Bradshaw T, Planner C, Parrott S, Michie S, Shepherd C. Bespoke smoking cessation for people with severe mental ill health (SCIMITAR): a pilot randomised controlled trial. Lancet Psychiatry. 2015 May;2(5):395-402. Epub 2015 Apr 28. https://doi.org/10.1016/S2215-0366(15)00091-7

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