Smoking Cessation Intervention for severe Mental Ill Health Trial (SCIMITAR): a pilot randomised evaluation of a bespoke smoking cessation service.

Background: There is a high prevalence of smoking amongst people who experience severe mental ill health (SMI). Helping people with disorders such as bipolar illness and schizophrenia to quit smoking would help improve their health, longevity and also reduce health inequalities. Around half of people with SMI who smoke express an interest in cutting down or quitting smoking. There is limited evidence that smoking cessation can be achieved for people with SMI. Those with SMIs rarely access routine NHS smoking cessation services. This suggests the need to develop and evaluate a behavioural support and medication package tailored to the needs of people with severe mental ill health. Objective: The objective in this project was to conduct a pilot trial to establish acceptability of the intervention and to ensure the feasibility of recruitment, randomization and follow-up. We also sought preliminary estimates of effect size in order to design a fully-powered trial of clinical and cost effectiveness. The pilot should inform a fully powered trial to compare the clinical and cost effectiveness of a bespoke smoking cessation intervention with usual GP care for people with severe mental ill health.Design: A pilot pragmatic two-arm individually randomised controlled trial. Simple randomisation was used following a computer generated random number sequence. Participants and practitioners were not blinded to allocation.Setting: Primary care and secondary care mental health services in England.Participants: Smokers aged >18 with a severe mental illness who would like to cut down or quit smoking.Interventions: A bespoke smoking cessation intervention delivered by mental health specialists trained to deliver evidence supported smoking cessation interventions compared with usual GP care.Main outcome measures: The primary outcome was carbon monoxide (CO)-verified smoking cessation at 12 months. Smoking related secondary outcomes were; reduction of number of cigarettes smoked, Fagerstrom test of nicotine dependence and motivation to quit. Other secondary outcomes were; PHQ-9 and SF-12 to assess whether there were improvements or deterioration in mental health, and quality of life. We also measured BMI to assess whether smoking cessation was associated with weight gain. These were measured at one, six and 12 months post randomisation.Results: The trial recruited 97 people aged 19-73. They smoked between 5-60 cigarettes per day (mean 25). Participants were recruited from four mental health trusts and 45 GP practices. Forty six people were randomised to the bespoke smoking cessation intervention and 51 people were randomised to usual GP care. The odds of quitting at 12 months was higher in the bespoke smoking cessation intervention (36 percent versus 23 percent) but did not reach statistical significance (Odds ratio 2.9, 95% confidence interval 0.8, 10.5). At three and six months there was no evidence of difference in self-report smoking cessation. There was a non-significant reduction in the number of cigarettes smoked and nicotine dependence. Motivation to quit and number of quit attempts all increased in the BSC group compared to usual care. There was no difference in terms of quality of life at any time point, but evidence of increase in depression scores at 12 months for the BSC group. There were no serious adverse events thought likely to be related to the trial interventions. The pilot economic analysis demonstrated that it was feasible to carry out a full economic analysis.Conclusions: It was possible to recruit people with SMI from primary and secondary care to a trial of a smoking cessation intervention based around behavioural support and medication. The overall direction of effect was a positive trend in relation to a biochemically-verified smoking cessation and it was feasible to obtain follow up in a substantial proportion of participants. A definitive trial of a bespoke cessation intervention has been prioritised by NIHR and the SCIMITAR pilot trial forms a template for a fully powered RCT to examine clinical and cost effectiveness.