Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR): a definitive randomised evaluation of a bespoke smoking cessation service
Smoking cessation services rarely account for the specific needs of people with severe mental illness, so this trial tests a tailored programme delivered by a mental health professional rather than a generic stop-smoking adviser. People with conditions such as schizophrenia or bipolar disorder smoke at much higher rates than the general population and die on average years earlier, often from smoking-related diseases. Standard NHS quit services are not designed for this group, and existing evidence on what works is thin. This randomised controlled trial compares a manualised "bespoke smoking cessation" service—combining nicotine replacement therapy, behavioural support, and gradual reduction over four months—against usual care, which is simply being signposted to existing services. If the bespoke service proves more effective, the NHS could adopt a dedicated smoking cessation pathway for people with severe mental illness, delivered by mental health staff who already know the patients. That would directly address a major driver of health inequality in a group that is often poorly served by generic public health programmes. The trial also includes an economic evaluation to assess whether the intervention offers value for money from both NHS and societal perspectives.
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We have already conducted a successful external pilot of the SCIMITAR trial and we propose a fully-powered trial in this challenging but important area. DESIGN: RCT, with concurrent economic evaluation. SETTING: mental services & primary care; with sites in York, Leeds &Bradford, North Yorkshire and the North East, South Yorkshire, Manchester and the North West, and North London. TARGET POPULATION: Adults with severe and enduring mental illness (SMI) who currently smoke, and are interested in cutting down/quitting. HEALTH TECHNOLOGY: In response to an NIHR commissioning brief we have already developed a manualised 'bespoke smoking cessation service' for people with SMI; delivered by a mental health professional. The Bespoke Smoking Cessation (BSC) service combines evidence-supported interventions (largely NRT & behavioural support), adapted to a patient population with SMI. The intervention has been developed in conjunction with the National Centre for Smoking Cessation Training (NCSCT). There is a strong emphasis on nicotine-supported smoking reduction and eventual quitting. The manualised bespoke service is offered on a 1:1 basis over four months for people with SMI in primary and secondary care settings. Pharmacotherapy is provided by the patients’ usual GP. This package of care has been shown to be acceptable, with good participant engagement in our developmental phase and pilot trial. A key feature is the delivery of manualised smoking cessation delivered by a mental health professional. The comparator technology is usual care (signposting to existing smoking cessation service provided by the patients' own GP practice or local NHS quit smoking services). PRIMARY OUTCOME: smoking cessation measured at 12 months post-randomisation (exhaled carbon monoxideand sustained self reported quitting ‘Russell standard’) – outcome specified by HTA at the commissioning phase of the pilot trial. SECONDARY OUTCOMES: carbon monoxide-verified smoking cessation at 3 and 6 months; Health Related Quality of Life (SF-12); Nicotine dependence, mood (PHQ9); patient satisfaction health, utility (EQ5D) at 3, 6 & 12 months ECONOMIC EVALUATION: the incremental cost per QALY of bespoke smoking cessation programme compared to usual care will be calculated from both the NHS and societal perspective. PROCESS EVALUATION: In our external pilot phase we have already examined acceptability (to patients with SMI and healthcare staff) and barriers and facilitators to the delivery and uptake of bespoke smoking cessations services using qualitative methods. We do not propose any further process evaluation in the definitive trial. SAMPLE SIZE: powered to detect a risk ratio of 1.8 or equivalently a 16% absolute difference in quit rates. To give 90% power (5% two sided sig.) to show a difference we require a sample size of 160 per group or 200 participants per group after allowing for 20% attrition (i.e. 400 in total). PROJECT TIMETABLES INCL. RECRUITMENT RATE: We will obtain ethical approval to continue the SCIMITAR trial following our successful pilot. We will extend recruitment to include five new centres. Months 0-6 site set up and R&D approvals. Months 6-24 recruitment. Month 36 last follow-up. Month 42 final report. There is agreement for excess treatment costs.
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