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Bespoke smoking cessation for people with severe mental ill health (SCIMITAR): a pilot randomised controlled trial

https://doi.org/10.1016/S2215-0366(15)00091-7Get rights and content

Summary

Background

People with severe mental ill health are three times more likely to smoke but typically do not access conventional smoking cessation services, contributing to widening health inequalities and reduced life expectancy. We aimed to pilot an intervention targeted at smokers with severe mental ill health and to test methods of recruitment, randomisation, and follow up before implementing a full trial.

Methods

The Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR) is a pilot randomised controlled trial of a smoking cessation strategy designed specifically for people with severe mental ill health, to be delivered by mental health nurses and consisting of behavioural support and drugs, compared with a conventional smoking cessation service (ie, usual care). Adults (aged 18 years or older) with bipolar disorder or schizophrenia, who were current smokers, were recruited from NHS primary care and mental health settings in the UK (York, Scarborough, Hull, and Manchester). Eligible participants were randomly allocated to either usual care (control group) or usual care plus the bespoke smoking cessation strategy (intervention group). Randomisation was done via a central telephone system, with computer-generated random numbers. We could not mask participants, family doctors, and researchers to the treatment allocation. Our primary outcome was smoking status at 12 months, verified by carbon monoxide measurements or self-report. Only participants who provided an exhaled CO measurement or self-reported their smoking status at 12 months were included in the primary analysis. The trial is registered at ISRCTN.com, number ISRCTN79497236.

Findings

Of 97 people recruited to the pilot study, 51 were randomly allocated to the control group and 46 were assigned to the intervention group. Participants engaged well with the bespoke smoking cessation strategy, but no individuals assigned to usual care accessed NHS smoking cessation services. At 12 months, 35 (69%) controls and 33 (72%) people assigned to the intervention group provided a CO measurement or self-reported their smoking status. Smoking cessation was highest among individuals who received the bespoke intervention (12/33 [36%] vs 8/35 [23%]; adjusted odds ratio 2·9, 95% CI 0·8–10·5).

Interpretation

We have shown the feasibility of recruiting and randomising people with severe mental ill health in a trial of this nature. The level of engagement with a bespoke smoking cessation strategy was higher than with a conventional approach. The effectiveness and safety of a smoking cessation programme designed particularly for people with severe mental ill health should be tested in a fully powered randomised controlled trial.

Funding

National Institute of Health Research Health Technology Assessment Programme.

Introduction

People with severe mental ill health, including schizophrenia and bipolar disorder, are more likely to smoke and to smoke heavily than are the general population.1, 2 The point prevalence of smoking among individuals with severe mental ill health has been estimated to be between 58% and 90%.3 People with severe mental ill health begin smoking at an earlier age and at a higher incidence4, 5 than do those without severe mental ill health. Furthermore, compared with the general population, individuals with severe mental ill health smoke every cigarette more intensely (ie, they take more and deeper inhalations), extracting a greater level of nicotine from each cigarette,6 are more dependent on nicotine, are more likely to develop smoking-related diseases, and are less likely to receive help in quitting.7

Smoking is part of the culture of mental health services, among both staff and patients.8 Many people with severe mental ill health are misinformed by health professionals about the risks and benefits of smoking versus treatment for nicotine dependence9 and they fear and overestimate the medical risks of nicotine-replacement treatments.10 Many individuals believe that smoking relieves depression and anxiety,11 whereas nicotine in fact increases anxiety.

Smoking contributes to the general poor physical health of individuals with severe mental ill health. Cohort studies show that people with disorders such as schizophrenia die on average 20–25 years earlier than do those without severe mental ill health, and smoking is the most important modifiable risk factor for this health inequality.12

Recent public health guidance issued by the UK National Institute for Health and Care Excellence (NICE) stresses that mental health services should become completely smoke free and that all people who use mental health services should be given full access to smoking cessation interventions.13 However, specific guidance is scarce on how smoking cessation services should be provided and in what way smoking cessation interventions might need to be adapted for individuals with severe mental ill health. Trial-based evidence suggests that people with severe mental ill health are able to give up smoking and that behavioural and pharmacological interventions to aid quitting might be as effective for people with severe mental ill health as they are for the general population.14 However, individuals with severe mental ill health do not generally access conventional smoking cessation services.15 In the general population, the rate of smoking is falling whereas little change has happened among people with severe mental ill health.16

To address this widening health inequality, we designed a smoking cessation intervention strategy specifically for people with severe mental ill health, based on evidence-supported behaviour change techniques and effective pharmacotherapy.17, 18 The strategy represents a means of organising and delivering smoking cessation services in a way that is responsive to the needs of people with severe mental ill health and that could boost the chances of them engaging with and using evidence-supported smoking cessation methods. In the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR), we aimed to compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation intervention with that of conventional UK National Health Service (NHS) smoking cessation methods in people with severe mental ill health. We sought preliminary evidence of clinical effectiveness in this population because doing a fully powered trial without this information would be premature.

Section snippets

Study design and participants

SCIMITAR is a pilot, pragmatic, two-arm, parallel group, randomised controlled trial to test recruitment, retention, and randomisation in people with severe mental ill health. We recruited participants from NHS primary care and mental health services in the UK (based in York, Scarborough, Manchester, and Hull). We judged people eligible for the trial if they were aged 18 years or older, had a severe mental health disorder, currently smoked, and had expressed an interest in cutting down smoking

Results

Between May, 2011, and May, 2012, we recruited 97 (of the planned 100) participants to the trial (figure 1); 51 were allocated to usual care (control group) and 46 were assigned to usual care plus the bespoke smoking cessation programme (intervention group). Groups were well balanced in terms of prognostic and sociodemographic characteristics (table 1). The median age of participants was 47·2 years (IQR 37·0–56·3). Mean duration of smoking was 27·1 years (SD 12·9, range 3–60) and a mean of 24·8

Discussion

The main findings of SCIMITAR are 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; however, we should be cautious

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