Smoking cessation for people with severe mental illness (SCIMITAR+): a pragmatic randomised controlled trial

Abstract

Summary Background People with severe mental illnesses such as schizophrenia are three times more likely to smoke than the wider population, contributing to widening health inequalities. Smoking remains the largest modifiable risk factor for this health inequality, but people with severe mental illness have not historically engaged with smoking cessation services. We aimed to test the effectiveness of a combined behavioural and pharmacological smoking cessation intervention targeted specifically at people with severe mental illness. Methods In the smoking cessation intervention for severe mental illness (SCIMITAR+) trial, a pragmatic, randomised controlled study, we recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK. Participants were eligible if they were aged 18 years or older, and smoked at least five cigarettes per day. Exclusion criteria included substantial comorbid drug or alcohol problems and people who lacked capacity to consent at the time of recruitment. Using computer-generated random numbers, participants were randomly assigned (1:1) to a bespoke smoking cessation intervention or to usual care. Participants, mental health specialists, and primary care physicians were unmasked to assignment. The bespoke smoking cessation intervention consisted of behavioural support from a mental health smoking cessation practitioner and pharmacological aids for smoking cessation, with adaptations for people with severe mental illness—such as, extended pre-quit sessions, cut down to quit, and home visits. Access to pharmacotherapy was via primary care after discussion with the smoking cessation specialist. Under usual care participants were offered access to local smoking cessation services not specifically designed for people with severe mental illnesses. The primary endpoint was smoking cessation at 12 months ascertained via carbon monoxide measurements below 10 parts per million and self-reported cessation for the past 7 days. Secondary endpoints were biologically verified smoking cessation at 6 months; number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence (FTND) and Motivation to Quit (MTQ) questionnaire; general and mental health functioning determined via the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) questionnaire, and 12-Item Short Form Health Survey (SF-12); and body-mass index (BMI). This trial was registerd with the ISRCTN registry, number ISRCTN72955454, and is complete. Findings Between Oct 7, 2015, and Dec 16, 2016, 526 eligible patients were randomly assigned to the bespoke smoking cessation intervention (n=265) or usual care (n=261). 309 (59%) participants were male, median age was 47·2 years (IQR 36·3–54·5), with high nicotine dependence (mean 24 cigarettes per day [SD 13·2]), and the most common severe mental disorders were schizophrenia or other psychotic illness (n=...

Smoking cessation in severe mental illness: combined long-term quit rates from the UK SCIMITAR trials programme

“…The design, methods and analysis of the SCIMITAR pilot and SCIMITAR+ trials were registered in the public domain (ISRCTN79497236 and ISRCTN72955454) and have been published elsewhere. 5,6 Briefly, the pragmatic SCIMITAR trials tested the effectiveness of a manualised combined behavioural and pharmacological intervention for people with SMI who smoked, compared with usual care. Participants received face-to-face behavioural support delivered by a mental health professional and were prescribed quit-smoking medication according to patient choice from a range of medications recommended by the National Centre for Smoking Cessation Training (NCSCT).…”

“…The trials programme followed the Medical Research Council's complex interventions framework, 4 by first designing a combined behavioural and pharmacological intervention specifically for people with SMIthe Smoking Cessation Intervention for People with Severe Mental Ill Health (SCIMITAR)and then undertaking a pilot trial (SCIMITAR), 5 before embarking on a full-scale randomised controlled trial (RCT) (SCIMITAR+) to determine clinical and cost-effectiveness. 6 Policymakers find precise longer-term estimates of quitting to be helpful, but the research literature is dominated by small sample sizes and short-term follow-up. 7 The SCIMITAR+ trial is the largest trial of smoking cessation in SMI to date, and has demonstrated the success of smoking cessation programmes in the short term (6 months).…”

“…7 The SCIMITAR+ trial is the largest trial of smoking cessation in SMI to date, and has demonstrated the success of smoking cessation programmes in the short term (6 months). 6 However, the SCIMITAR+ trial still lacked sufficient power to detect the expected differences in the prespecified primary outcome and might have failed to detect anticipated differences in long-term outcomes (making a type 2 error). In this short report we combine pilot and full-trial data to maximise the power and precision of long-term estimates of smoking cessation.…”

Mental health, smoking, harm reduction and quit attempts – a population survey in England

“…Speci c challenges such as higher dependence on tobacco need to be addressed by making effective support available. A combination of behavioural support and medication is most effective in the wider population of smokers and has been shown to be effective for smokers with severe mental illness (14,15) and for smokers with and without mental health problems making quit attempts (40). In quit attempts and accompanied by behavioural support, e-cigarettes have been shown to be more effective than NRT (41).…”

Everything you wanted to know about e-cigarettes and vaping but were afraid to ask: a guide for mental health clinicians

“…Research evidence derived from systematic reviews is strongly supportive of the effectiveness of smoking cessation programmes among people with severe mental illness (Peckham 2017), and there has been a large-scale trial of this in the UK (Gilbody 2019).…”