Search

Introduction: The prevalence of smoking is high among people living with severe mental illness (SMI). Evidence on feasibility, acceptability and effectiveness of smoking cessation interventions among smokers with SMI is lacking, particularly in low- and middle-income countries. We aim to test the feasibility and acceptability of delivering an evidence-based intervention,i.e., the IMPACT smoking cessation support for people with severe mental illness in South Asia (IMPACT 4S) intervention that is a combination of behavioural support and smoking cessation pharmacotherapies among adult smokers with SMI in India and Pakistan. We will also test the feasibility and acceptability of evaluating the intervention in a randomised controlled trial., Methods: We will conduct a parallel, open label, randomised controlled feasibility trial among 172 (86 in each country) adult smokers with SMI in India and Pakistan. Participants will be allocated 1:1 to either Brief Advice (BA) or the IMPACT 4S intervention. BA comprises a single five-minute BA session on stopping smoking. The IMPACT 4S intervention comprises behavioural support delivered in upto 15 one-to-one, face-to-face or audio/video, counselling sessions, with each session lasting between 15 and 40 minutes; nicotine gum and/or bupropion; and breath carbon monoxide monitoring and feedback. Outcomes are recruitment rates, reasons for ineligibility/non-participation/non-consent of participants, length of time required to achieve required sample size, retention in study and treatments, intervention fidelity during delivery, smoking cessation pharmacotherapy adherence and data completeness. We will also conduct a process evaluation., Results: Study will address- uncertainty about feasibility and acceptability of delivering smoking cessation interventions, and ability to conduct smoking cessation trials, among adult smokers with SMI in low- and middle-income countries., Conclusions: This is to inform further intervention adaptation, and the design and conduct of future randomised controlled trials on this topic. Results will be disseminated through peer-review articles, presentations at national, international conferences and policy-engagement forums., Trial Registration: ISRCTN34399445 (Updated 22/03/2021), ISRCTN Registry https://www.isrctn.com/., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Mazumdar et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background and Aims: People with severe mental ill health smoke more and suffer greater smoking-related morbidity and mortality. Little is known about the effectiveness of behavioural interventions for smoking cessation in this group. This review evaluated randomized controlled trial evidence to measure the effectiveness of behavioural smoking cessation interventions (both digital and non-digital) in people with severe mental ill health., Design: Systematic review and random-effects meta-analysis. We searched between inception and January 2020 in Medline, EMBASE, PsycINFO, CINAHL, Health Management Information Consortium and CENTRAL databases., Setting and Participants: Randomized controlled trials (RCTs) assessing the effects of behavioural smoking cessation and reduction interventions in adults with severe mental ill health, conducted in any country, in either in-patient or community settings and published in English., Measurements: The primary outcome was biochemically verified smoking cessation. Smoking reduction and changes in mental health symptoms and body mass index (BMI) were included as secondary outcomes. Narrative data synthesis and meta-analysis were conducted and the quality of included studies was appraised using the risk of bias 2 (RoB2) tool., Findings: We included 12 individual studies (16 articles) involving 1861 participants. The first meta-analysis (three studies, 921 participants) demonstrated effectiveness of bespoke face-to-face interventions compared with usual care across all time-points [medium-term: relative risk (RR) = 2.29, 95% confidence interval (CI) = 1.38-3.81; long-term: RR = 1.58, 95% CI = 1.09-2.30]. The second (three studies, 275 participants) did not demonstrate any difference in effectiveness of bespoke digital on-line interventions compared with standard digital on-line interventions (medium-term: RR = 0.87, 95% CI = 0.17-4.46). A narrative overview revealed mixed results when comparing bespoke face-to-face interventions with other active interventions. The methodological quality of studies was mixed, with the majority having some concerns mainly around risk of selective reporting., Conclusions: Face-to-face bespoke smoking cessation interventions for adults with severe mental ill health appear to be effective when compared with treatment as usual, but evidence is equivocal when compared with other active interventions. There is limited evidence comparing bespoke digital interventions with generic interventions, and we found no studies comparing them with usual treatment., (© 2021 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Background and Aims: Admission to a smoke-free setting presents a unique opportunity to encourage smokers to quit. However, risk of relapse post-discharge is high, and little is known about effective strategies to support smoking cessation following discharge. We aimed to identify interventions that maintain abstinence following a smoke-free stay and determine their effectiveness, as well as the probable effectiveness of behaviour change techniques (BCTs) used in these interventions., Methods: Systematic review and meta-analyses of studies of adult smokers aged ≥ 18 years who were temporarily or fully abstinent from smoking to comply with institutional smoke-free policies. Institutions included prison, inpatient mental health, substance misuse or acute hospital settings. A Mantel-Haenszel random-effects meta-analysis of randomized controlled trials (RCTs) was conducted using biochemically verified abstinence (7-day point prevalence or continuous abstinence). BCTs were defined as 'promising' in terms of probable effectiveness (if BCT was present in two or more long-term effective interventions) and feasibility (if BCT was also delivered in ≥ 25% of all interventions)., Results: Thirty-seven studies (intervention n = 9041, control n = 6195) were included: 23 RCTs (intervention n = 6593, control n = 5801); three non-randomized trials (intervention n = 845, control n = 394) and 11 cohort studies (n = 1603). Meta-analysis of biochemically verified abstinence at longest follow-up (4 weeks-18 months) found an overall effect in favour of intervention [risk ratio (RR) = 1.27, 95% confidence interval (CI) = 1.08-1.49, I 2  = 42%]. Nine BCTs (including 'pharmacological support', 'goal-setting (behaviour)' and 'social support') were characterized as 'promising' in terms of probable effectiveness and feasibility., Conclusions: A systematic review and meta-analyses indicate that behavioural and pharmacological support is effective in maintaining smoking abstinence following a stay in a smoke-free institution. Several behaviour change techniques may help to maintain smoking abstinence up to 18 months post-discharge., (© 2021 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Objectives: People with mental disorders are more likely to smoke than the general population. The objective of this study is to develop a decision analytical model that estimates long-term cost-effectiveness of smoking cessation interventions in this population., Methods: A series of Markov models were constructed to estimate average lifetime smoking-attributable inpatient cost and expected quality-adjusted life-years. The model parameters were estimated using a variety of data sources. The model incorporated uncertainty through probabilistic sensitivity analysis using Monte Carlo simulations. It also generated tables presenting incremental cost-effectiveness ratios of the proposed interventions with varying incremental costs and incremental quit rates. We used data from 2 published trials to demonstrate the model's ability to make projections beyond the observational time frame., Results: The average smoker's smoking-attributable inpatient cost was 3 times higher and health utility was 5% lower than ex-smokers. The intervention in the trial with a statistically insignificant difference in quit rate (19% vs 25%; P=.2) showed a 45% to 49% chance of being cost-effective compared with the control at willingness-to-pay thresholds of £20 000 to £30 000/quality-adjusted life-years. The second trial had a significant outcome (quit rate 35.9% vs 15.6%; P<.001), and the corresponding probability of the intervention being cost-effective was 65%., Conclusions: This model provides a consistent platform for clinical trials to estimate the potential lifetime cost-effectiveness of smoking cessation interventions for people with mental disorders and could help commissioners direct resources to the most cost-effective programs. However, direct comparisons of results between trials must be interpreted with caution owing to their different designs and settings., (Copyright © 2021 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Smoking contributes to health inequalities for people with severe mental illness (SMI). Although smoking cessation interventions are effective in the short term, there are few long-term trial-based estimates of abstinence. The SCIMITAR trials programme includes the largest trial to date of a smoking cessation intervention for people with SMI, but this was underpowered to detect anticipated long-term quit rates. By pooling pilot and full-trial data we found that quit rates were maintained at 12 months (OR = 1.67, 95% CI 1.02-2.73, P = 0.04). Policymakers can now be confident that bespoke smoking cessation interventions produce successful short- and long-term quitting.

Aims: To evaluate the cost-effectiveness of a specialist smoking cessation package for people with severe mental illness DESIGN: Incremental cost-effectiveness analysis was undertaken from the UK National Health Service and Personal Social Services perspective over a 12-month time horizon. Total costs, including smoking cessation, health-care and social services costs and quality-adjusted life years (QALYs), derived from the five-level EuroQol 5-dimension (EQ-5D-5 L), collected from a randomized controlled trial, were used as outcome measures. The bootstrap technique was employed to assess the uncertainty., Setting: Sixteen primary care and 21 secondary care mental health sites in England., Participants: Adult smokers with bipolar affective disorder, schizoaffective disorder or schizophrenia and related illnesses (n = 526)., Intervention and Comparator: A bespoke smoking cessation (BSC) package for people with severe mental illness offered up to 12 individual sessions with a mental health smoking cessation practitioner versus usual care (UC). Of the participants who were randomized, 261 were in UC group and 265 were in BSC group., Measurements: BSC intervention cost was estimated from the treatment log. Costs of UC, health-care and social services and EQ-5D-5 L were collected at baseline, 6- and 12-month follow-ups. Incremental costs and incremental QLAYs were estimated using regression adjusting for respective baseline values and other baseline covariates., Findings: The mean total cost in the BSC group was £270 [95% confidence interval (CI) = -£1690 to £1424] lower than in the UC group, while the mean QALYs were 0.013 (95% CI = -0.008 to 0.045) higher, leading to BSC dominating UC (76% probability of cost-effective at £20 000/QALY)., Conclusions: A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services., (© 2020 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Introduction: Smoking is more prevalent among people with severe mental illness (SMI) than the general population. E-cigarettes could provide an effective means of helping people to quit smoking. The aim of this paper is to explore the use of e-cigarettes and factors related to their use in people smokers with SMI., Methods: This is a cross sectional study including adult smokers with a documented diagnosis of SMI (ICD-10) recruited to the SCIMITAR + trial (2015-2016) from primary and secondary care. At baseline, participants were asked for demographic information and about their use of e-cigarettes. Data was were analysed to explore factors associated with e-cigarette use. After testing bivariate associations, logistic regressions were conducted., Results: Among 526 participants, 58.7% were male, mean age 46 years (SD 12.1), the majority (70.3%) had tried an e-cigarette. Among those who had ever tried an e-cigarette, over half (54.6%) reported the reason was to quit smoking, while 13.9% reported that the reason was to reduce smoking. Having an educational qualification of GCSE or higher (odds ratio 2.17, 95% CI 1.22 to 3.86, p = 0.008) and having made a quit attempt in the past six months (OR 1.66, 95% CI 1.04 to 2.63, p = 0.032) was associated with ever having tried an e-cigarette., Conclusions: Ever use of an e-cigarette was associated with education levels and recent quit attempts. Future trials could explore the effectiveness of e-cigarettes as a cessation aid in this participant group., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: There is a high prevalence of smoking among people with severe mental ill health (SMI). Helping people with SMI to quit smoking could improve their health and longevity, and reduce health inequalities. However, those with SMI are less likely to access and engage with routine smoking cessation services than the general population., Objectives: To compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual stop smoking services for people with SMI., Design: A pragmatic, two-arm, individually randomised controlled trial., Setting: Primary care and secondary care mental health services in England., Participants: Smokers aged ≥ 18 years with SMI who would like to cut down on or quit smoking., Interventions: A BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual care., Main Outcome Measures: The primary outcome was self-reported, CO-verified smoking cessation at 12 months. Smoking-related secondary outcomes were self-reported smoking cessation, the number of cigarettes smoked per day, the Fagerström Test for Nicotine Dependence and the Motivation to Quit questionnaire. Other secondary outcomes were Patient Health Questionnaire-9 items, Generalised Anxiety Disorder Assessment-7 items and 12-Item Short-Form Health Survey, to assess mental health and body mass index measured at 6 and 12 months post randomisation., Results: The trial randomised 526 people (265 to the intervention group, 261 to the usual-care group) aged 19 to 72 years (mean 46 years). About 60% of participants were male. Participants smoked between 3 and 100 cigarettes per day (mean 25 cigarettes per day) at baseline. The intervention group had a higher rate of exhaled CO-verified smoking cessation at 6 and 12 months than the usual-care group [adjusted odds ratio (OR) 12 months: 1.6, 95% confidence interval (CI) 0.9 to 2.8; adjusted OR 6 months: 2.4, 95% CI 1.2 to 4.7]. This was not statistically significant at 12 months ( p  = 0.12) but was statistically significant at 6 months ( p  = 0.01). In total, 111 serious adverse events were reported (69 in the BSC group and 42 in the usual-care group); the majority were unplanned hospitalisations due to a deterioration in mental health ( n  = 98). The intervention is likely (57%) to be less costly but more effective than usual care; however, this result was not necessarily associated with participants' smoking status., Limitations: Follow-up was not blind to treatment allocation. However, the primary outcome included a biochemically verified end point, less susceptible to observer biases. Some participants experienced difficulties in accessing nicotine replacement therapy because of changes in service provision. Efforts were made to help participants access nicotine replacement therapy, but this may have affected participants' quit attempt., Conclusions: People with SMI who received the intervention were more likely to have stopped smoking at 6 months. Although more people who received the intervention had stopped smoking at 12 months, this was not statistically significant., Future Work: Further research is needed to establish how quitting can be sustained among people with SMI., Trial Registration: Current Controlled Trials ISRCTN72955454., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 50. See the NIHR Journals Library website for further project information., Competing Interests: Catherine Hewitt is a member of the Health Technology Assessment Commissioning Board. Suzy Ker reports personal fees from the NHS outside the submitted work.

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=343 [65%]), bipolar disorder (n=115 [22%]), and schizoaffective disorder (n=66 [13%]). 234 (88%) of intervention participants engaged with the treatment programme and attended 6·4 (SD 3·5) quit smoking sessions, with an average duration of 39 min (SD 17; median 35 min, range 5-120). Verified quit data at 12 months were available for 219 (84%) of 261 usual care and 223 (84%) of 265 intervention participants. The proportion of participants who had quit at 12 months was higher in the intervention group than in the usual care group, but non-significantly (34 [15%] of 223 [13% of those assigned to group] vs 22 [10%] of 219 [8% of those assigned to group], risk difference 5·2%, 95% CI -1·0 to 11·4; odds ratio [OR] 1·6, 95% CI 0·9 to 2·9; p=0·10). The proportion of participants who quit at 6 months was significantly higher in the intervention group than in the usual care group (32 [14%] of 226 vs 14 [6%] of 217; risk difference 7·7%, 95% CI 2·1 to 13·3; OR 2·4, 95% CI 1·2 to 4·6; p=0·010). The incidence rate ratio for number of cigarettes smoked per day at 6 months was 0·90 (95% CI 0·80 to 1·01; p=0·079), and at 12 months was 1·00 (0·89 to 1·13; p=0·95). At both 6 months and 12 months, the intervention group was non-significantly favoured in the FTND (adjusted mean difference 6 months -0·18, 95% CI -0·53 to 0·17, p=0·32; and 12 months -0·01, -0·39 to 0·38, p=0·97) and MTQ questionnaire (adjusted mean difference 0·58, -0·01 to 1·17, p=0·056; and 12 months 0·64, 0·04 to 1·24, p=0·038). The PHQ-9 showed no difference between the groups (adjusted mean difference at 6 months 0·20, 95% CI -0·85 to 1·24 vs 12 months -0·12, -1·18 to 0·94). For the SF-12 survey, we saw evidence of improvement in physical health in the intervention group at 6 months (adjusted mean difference 1·75, 95% CI 0·21 to 3·28), but this difference was not evident at 12 months (0·59, -1·07 to 2·26); and we saw no difference in mental health between the groups at 6 or 12 months (adjusted mean difference at 6 months -0·73, 95% CI -2·82 to 1·36, and 12 months -0·41, -2·35 to 1·53). The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86). No difference in BMI was seen between the groups (adjusted mean difference 6 months 0·16, 95% CI -0·54 to 0·85; 12 months 0·25, -0·62 to 1·13)., Interpretation: This bespoke intervention is a candidate model of smoking cessation for clinicians and policy makers to address high prevalence of smoking. The incidence of quitting at 6 months shows that smoking cessation can be achieved, but the waning of this effect by 12 months means more effort is needed for sustained quitting., Funding: National Institute for Health Research Health Technology Assessment Programme., (Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations., Methods: SCIMITAR+ is a multi-centre pragmatic two-arm parallel-group RCT, which aimed to recruit 400 participants with severe mental ill health who smoke and would like to cut down or quit. The study recruited primarily in secondary care through community mental health teams and psychiatrists with a smaller number of participants recruited through primary care. Recruitment opened in October 2015 and closed in December 2016, by which point 526 participants had been recruited. We gathered information from recruiting sites on strategies which led to the successful recruitment in SCIMITAR+ and in this article present our approach to trial management along with the strategies employed by the recruiting sites., Results: Alongside having a dedicated trial manager and trial management team, we identified three main themes that led to successful recruitment. These were: clinicians with a positive attitude to research; researchers and clinicians working together; and the use of NHS targets. The overriding theme was the importance of relationships between both the researchers and the recruiting clinicians and the recruiting clinicians and the participants., Conclusions: This study makes a significant contribution to the limited evidence base of real-world cases of successful recruitment to RCTs and offers practical guidance to those planning and conducting trials. Building positive relationships between clinicians, researchers and participants is crucial to successful recruitment.

Aims: We compared predicted life-time health-care costs for current, never and ex-smokers in Germany under the current set of tobacco control polices. We compared these economic consequences of the current situation with an alternative in which Germany were to implement more comprehensive tobacco control policies consistent with the World Health Organization (WHO) Framework Convention for Tobacco Control (FCTC) guidelines., Design: German EstSmoke, an adapted version of the UK EstSmoke simulation model, applies the Markov modelling approach. Transition probabilities for (re-)currence of smoking-related diseases were calculated from large German disease-specific registries and the German Health Update (GEDA 2010). Estimations of both health-care costs and effect sizes of smoking cessation policies were taken from recent German studies and discounted at 3.5%/year., Setting: Germany., Participants: German population of prevalent current, never and ex-smokers in 2009., Measurement: Life-time cost and outcomes in current, never and ex-smokers., Findings: If tobacco control policies are not strengthened, the German smoking population will incur €41.56 billion life-time excess costs compared with never smokers. Implementing tobacco control policies consistent with WHO FCTC guidelines would reduce the difference of life-time costs between current smokers and ex-smokers by at least €1.7 billion., Conclusions: Modelling suggests that the life-time healthcare costs of people in Germany who smoke are substantially greater than those of people who have never smoked. However, more comprehensive tobacco control policies could reduce health-care expenditures for current smokers by at least 4%., (© 2017 Society for the Study of Addiction.)

Background: People with severe mental ill health are more likely to smoke than those in the general population. It is therefore important that effective smoking cessation strategies are used to help people with severe mental ill health to stop smoking. This study aims to assess the effectiveness and cost -effectiveness of smoking cessation and reduction strategies in adults with severe mental ill health in both inpatient and outpatient settings., Methods: This is an update of a previous systematic review. Electronic databases were searched during September 2016 for randomised controlled trials comparing smoking cessation interventions to each other, usual care, or placebo. Data was extracted on biochemically-verified, self-reported smoking cessation (primary outcome), as well as on smoking reduction, body weight, psychiatric symptom, and adverse events (secondary outcomes)., Results: We included 26 trials of pharmacological and/or behavioural interventions. Eight trials comparing bupropion to placebo were pooled showing that bupropion improved quit rates significantly in the medium and long term but not the short term (short term RR = 6.42 95% CI 0.82-50.07; medium term RR = 2.93 95% CI 1.61-5.34; long term RR = 3.04 95% CI 1.10-8.42). Five trials comparing varenicline to placebo showed that that the addition of varenicline improved quit rates significantly in the medium term (RR = 4.13 95% CI 1.36-12.53). The results from five trials of specialised smoking cessation programmes were pooled and showed no evidence of benefit in the medium (RR = 1.32 95% CI 0.85-2.06) or long term (RR = 1.33 95% CI 0.85-2.08). There was insufficient data to allowing pooling for all time points for varenicline and trials of specialist smoking cessation programmes. Trials suggest few adverse events although safety data were not always reported. Only one pilot study reported cost effectiveness data., Conclusions: Bupropion and varenicline, which have been shown to be effective in the general population, also work for people with severe mental ill health and their use in patients with stable psychiatric conditions. Despite good evidence for the effectiveness of smoking cessation interventions for people with severe mental ill health, the percentage of people with severe mental ill health who smoke remains higher than that for the general population.

Background: Smoking is highly prevalent among people who have experience of severe mental ill health, contributing to their poor physical health. Despite the 'culture' of smoking in mental health services, people with severe mental ill health often express a desire to quit smoking; however, the services currently available to aid quitting are those which are widely available to the general population and may not be suitable or effective for people with severe mental ill health. The aim of this study is to explore the effectiveness and cost-effectiveness of a bespoke smoking-cessation intervention specifically targeted at people with severe mental ill health., Methods/design: SCIMITAR+ is a multicentre, pragmatic, two-arm, parallel-group, individually randomised controlled trial. We aim to recruit 400 participants aged 18 years and above with a documented diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder who smoke. Potentially eligible participants identified in primary or secondary care will be screened, and baseline data collected. Eligible, consenting participants will be randomly allocated to one of two groups. In the intervention arm, the participant will be assigned a mental health professional trained to deliver smoking-cessation interventions who will work with the participant and participant's GP or mental health specialist to provide an individually tailored smoking-cessation service. The comparator arm will be usual care - following current NICE guidelines for smoking cessation, in line with general guidance that is offered to all smokers, with no specific adaptation or enhancement in relation to severe mental ill health. The primary outcome will be self-reported smoking cessation at 12 months verified by expired carbon monoxide (CO) measurement. Secondary outcome measures include Body Mass Index at 12 months, the Fagerström Test for Nicotine Dependence, Motivation to Quit questionnaire, SF-12, PHQ-9, GAD-7, EQ-5D-5 L, and health service utilisation at 6 and 12 months. The economic evaluation at 12 months will be conducted in the form of an incremental cost-effectiveness analysis., Discussion: SCIMITAR+ trial is the largest trial to our knowledge to investigate the effectiveness of a bespoke smoking-cessation service for people with severe mental ill health., Trial Registration: International Standard Randomised Controlled Trials Number, ISRCTN72955454 . Registered on 16 January 2015.

Aims: To determine the effectiveness and safety of varenicline in treating tobacco dependence in patients with severe mental illness., Design: A systematic review and meta-analysis of randomised controlled trials that compared varenicline with a placebo or an alternative intervention for smoking cessation or reduction., Setting: Both in- and out-patient settings in any country., Participants: Adult patients aged 18 years and over with any type of severe mental illness. The systematic review included eight studies comprising 398 participants., Measures: Primary outcome measures were (1) smoking cessation, (2) smoking reduction measured by changes in the number of cigarettes smoked per day and (3) number of psychiatric adverse events, which were collected at the end of treatment., Findings: The random-effect pooled estimates from the five studies that reported smoking-related outcomes found that varenicline is statistically superior to placebo in smoking cessation [risk ratios 4.33; 95% confidence interval (CI) = 1.96-9.56], and smoking reduction was higher in varenicline groups (mean reduced daily cigarettes was 6.39; 95% CI = 2.22-10.56). There is no significant difference regarding neuropsychiatric and other adverse events., Conclusions: Varenicline appears to be significantly more effective than placebo in assisting with smoking cessation and reduction in people with severe mental illness. There appears to be no clear evidence that varenicline was associated with an increased risk of neuropsychiatric or other adverse events compared with placebo., (© 2016 Society for the Study of Addiction.)

Background: Smoking is one of the major modifiable risk factors contributing to early mortality for people with serious mental illness. However, only a minority of service users access smoking cessation interventions and there are concerns about the appropriateness of generic stop-smoking services for this group. The SCIMITAR (Smoking Cessation Intervention for Severe Mental Ill-Health Trial) feasibility study explored the effectiveness of a bespoke smoking cessation intervention delivered by mental health workers. This paper reports on the nested qualitative study within the trial., Methods: Qualitative semi-structured interviews were conducted with 13 service users receiving the intervention and 3 of the MHSCPs (mental health smoking cessation practitioners) delivering the intervention. Topic guides explored the perceived acceptability of the intervention particularly in contrast to generic stop-smoking services, and perceptions of the implementation of the intervention in practice. Transcripts were analysed using the Constant Comparative Method., Results: Generic services were reported to be inappropriate for this group, due to concerns over stigma and a lack of support from health professionals. The bespoke intervention was perceived positively, with both practitioners and service users emphasising the benefits of flexibility and personalisation in delivery. The mental health background of the practitioners was considered valuable not only due to their increased understanding of the service users' illness but also due to the more collaborative relationship style they employed. Challenges involved delays in liaising with general practitioners and patient struggles with organisation and motivation, however the MHSCP was considered to be well placed to address these problems., Conclusion: The bespoke smoking cessation intervention was acceptable to service users and the both service users and practitioners reported the value of a protected mental health worker role for delivering smoking cessation to this group. The results have wider implications for understanding how to achieve integrated and personalised care for this high-risk population and further underscore the need for sensitised smoking cessation support for people with serious mental illness., Trial Registration: Current Controlled Trials ISRCTN79497236 . Registered 3(rd) July 2009.

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., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: There is a high prevalence of smoking among 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, increase 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 SMI 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 SMI., 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, randomisation and follow-up. We also sought preliminary estimates of effect size in order to design a fully powered trial of clinical effectiveness and cost-effectiveness. The pilot should inform a fully powered trial to compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual general practitioner (GP) care for people with SMI., Design: A pilot pragmatic two-arm individually randomised controlled trial (RCT). 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 years with a severe mental illness who would like to cut down or quit smoking., Interventions: A BSC 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-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 (MTQ). Other secondary outcomes were Patient Health Questionnaire-9 items and Short Form Questionnaire-12 items to assess whether there were improvements or deterioration in mental health and quality of life. We also measured body mass index to assess whether or not smoking cessation was associated with weight gain. These were measured at 1, 6 and 12 months post randomisation., Results: The trial recruited 97 people aged 19-73 years who smoked between 5 and 60 cigarettes per day (mean 25 cigarettes). Participants were recruited from four mental health trusts and 45 GP surgeries. Forty-six people were randomised to the BSC intervention and 51 people were randomised to usual GP care. The odds of quitting at 12 months was higher in the BSC intervention (36% vs. 23%) but did not reach statistical significance (odds ratio 2.9; 95% confidence interval 0.8% to 10.5%). At 3 and 6 months there was no evidence of difference in self-reported smoking cessation. There was a non-significant reduction in the number of cigarettes smoked and nicotine dependence. MTQ and number of quit attempts all increased in the BSC group compared with usual care. There was no difference in terms of quality of life at any time point, but there was evidence of an 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 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 the National Institute for Health Research (NIHR) and the SCIMITAR pilot trial forms a template for a fully powered RCT to examine clinical effectiveness and cost-effectiveness., Trial Registration: Current Controlled Trials ISRCTN79497236., Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment, Vol. 19, No. 25. See the NIHR Journals Library website for further project information.

Aims: The physical health of people with severe mental illness (SMI) is poor. Smoking-related illnesses are a major contributor to excess mortality and morbidity. An up-to-date review of the evidence for smoking cessation interventions in SMI is needed to inform clinical guidelines., Methods: We searched bibliographic databases for relevant studies and independently extracted data. Included studies were randomized controlled trials (RCTs) of smoking cessation or reduction conducted in adult smokers with SMI. Interventions were compared to usual care or placebo. The primary outcome was smoking cessation and secondary outcomes were smoking reduction, change in weight, change in psychiatric symptoms and adverse events., Results: We included eight RCTs of pharmacological and/or psychological interventions. Most cessation interventions showed moderate positive results, some reaching statistical significance. One study compared behavioural support and nicotine replacement therapy (NRT) to usual care and showed a risk ratio (RR) of 2.74 (95% CI 1.10-6.81) for short-term smoking cessation, which was not significant at longer follow-up. We pooled five trials that effectively compared bupropion to placebo giving an RR of 2.77 (95% CI 1.48-5.16), which was comparable to Hughes et al.'s 2009 figures for general population data; RR = 1.69 (95% CI 1.53-1.85). Smoking reduction data were too heterogeneous for meta-analysis, but results were generally positive. Trials suggest few adverse events. All trials recorded psychiatric symptoms and the most significant changes favoured the intervention groups over the control groups., Conclusions: Treating tobacco dependence is effective in patients with SMI. Treatments that work in the general population work for those with severe mental illness and appear approximately equally effective. Treating tobacco dependence in patients with stable psychiatric conditions does not worsen mental state.

Introduction Evidence suggests that smokers can successfully quit, remain abstinent or reduce smoking during a smoke-free mental health inpatient stay, provided behavioral/pharmacological support are offered. However, few evidence-based strategies to prevent the return to prehospital smoking behaviors post-discharge exist. Aims and Methods We report the development of an intervention designed to support smoking-related behavior change following discharge from a smoke-free mental health stay. We followed the Behavior Change Wheel (BCW) intervention development process. The target behavior was supporting patients to change their smoking behaviors following discharge from a smoke-free mental health stay. Using systematic reviews, we identified the barriers and enablers, classified according to the Theoretical Domains Framework (TDF). Potential intervention functions to address key influences were identified by consulting the BCW and Behavior Change Technique (BCT) taxonomy. Another systematic review identified effectiveness of BCTs in this context. Stakeholder consultations were conducted to prioritize and refine intervention content. Results Barriers and enablers to supporting smoking cessation were identified within the domains of environmental context and resources (lack of staff time); knowledge (ill-informed interactions about smoking); social influences, and intentions (lack of intention to deliver support). Potential strategies to address these influences included goal setting, problem-solving, feedback, social support, and information on health consequences. A strategy for operationalizing these techniques into intervention components was agreed upon: Pre-discharge evaluation sessions, a personalized resource folder, tailored behavioral and text message support post-discharge, and a peer interaction group, delivered by a trained mental health worker. Conclusions The intervention includes targeted resources to support smoking-related behavior change in patients following discharge from a smoke-free mental health setting. Implications Using the BCW and TDF supported a theoretically and empirically informed process to define and develop a tailored intervention that acknowledges barriers and enablers to supporting smoking cessation in mental health settings. The result is a novel complex theory- and evidence-based intervention that will be formally tested in a randomized controlled feasibility study. [ABSTRACT FROM AUTHOR]

Introduction: People with severe mental illness (SMI) are more likely to have obesity and engage in health risk behaviours than the general population. The aims of this study are (1) evaluate the effectiveness of interventions that focus on body weight, smoking cessation, improving sleeping patterns, and alcohol and illicit substance abuse; (2) Compare the number of interventions addressing body weight and health risk behaviours in low- and middle-income countries (LMICs) v. those reported in published systematic reviews focusing on high-income countries (HICs). Methods: Intervention studies published up to December 2020 were identified through a structured search in the following database; OVID MEDLINE (1946–December 2020), EMBASE (1974–December 2020), CINAHL (1975–2020), APA PsychoINFO (1806–2020). Two authors independently selected studies, extracted study characteristics and data and assessed the risk of bias. and risk of bias was assessed using the Cochrane risk of bias tool V2. We conducted a narrative synthesis and, in the studies evaluating the effectiveness of interventions to address body weight, we conducted random-effects meta-analysis of mean differences in weight gain. We did a systematic search of systematic reviews looking at cardiometabolic and health risk behaviours in people with SMI. We compared the number of available studies of LMICs with those of HICs. Results: We assessed 15 657 records, of which 9 met the study inclusion criteria. Six focused on healthy weight management, one on sleeping patterns and two tested a physical activity intervention to improve quality of life. Interventions to reduce weight in people with SMI are effective, with a pooled mean difference of −4.2 kg (95% CI −6.25 to −2.18, 9 studies, 459 participants, I 2 = 37.8%). The quality and sample size of the studies was not optimal, most were small studies, with inadequate power to evaluate the primary outcome. Only two were assessed as high quality (i.e. scored 'low' in the overall risk of bias assessment). We found 5 reviews assessing the effectiveness of interventions to reduce weight, perform physical activity and address smoking in people with SMI. From the five systematic reviews, we identified 84 unique studies, of which only 6 were performed in LMICs. Conclusion: Pharmacological and activity-based interventions are effective to maintain and reduce body weight in people with SMI. There was a very limited number of interventions addressing sleep and physical activity and no interventions addressing smoking, alcohol or harmful drug use. There is a need to test the feasibility and cost-effectiveness of context-appropriate interventions to address health risk behaviours that might help reduce the mortality gap in people with SMI in LMICs. [ABSTRACT FROM AUTHOR]

Background: People with severe mental ill health (SMI) experience a mortality gap of 15–20 years. COVID-19 has amplified population health inequalities, and there is concern that people with SMI will be disproportionately affected. Understanding how health risk behaviours have changed during the pandemic is important when developing strategies to mitigate future increases in health inequalities. Methods: We sampled from an existing cohort of people with SMI. Researchers contacted participants by phone or post to invite them to take part in a survey about how the pandemic had affected them. We asked people about their health risk behaviours and how these had changed during the pandemic. We created an index of changed behaviours, comprising dietary factors, smoking, lack of exercise, and drinking patterns. By creating data linkages, we compared their responses during pandemic restrictions to responses they gave prior to the pandemic. Outcomes: 367 people provided health risk data. The mean age of the participants was 50.5 (range = 20 to 86, SD ± 15.69) with 51.0% male and 77.4% white British. 47.5% of participants reported taking less physical activity during the pandemic and of those who smoke 54.5% reported smoking more heavily. Self-reported deterioration in physical health was significantly associated with an increase in health risk behaviours (adjusted OR for physical health 1.59, 95%CI 1.22–2.07; adjusted OR for Age 0.99, 95%CI 0.98–1.00). Interpretation: COVID-19 is likely to amplify health inequalities for people with SMI. Health services should target health risk behaviours for people with SMI to mitigate the immediate and long lasting impacts of the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

SUMMARY: Mental health clinicians are expected to offer support and advice to patients to promote smoking cessation. Alongside this is the relatively new and increasingly popular phenomenon of electronic cigarette use. The absence of any long-term evidence regarding safety is recognised and clinicians' awareness of e-cigarettes may be limited to personal experience or media publications, leading to uncertainty in their confidence discussing e-cigarettes with patients, both in general and as an aid to quitting smoking. This article provides a historical and contemporary overview of e-cigarettes and vaping. The reader will gain an understanding of e-cigarette usage, risks and benefits, the current position on use of e-cigarettes in mental health settings, and tips on how to take an e-cigarette/vaping history and how to offer advice about use. This is achieved in the context of recent publications and national recommendations. Although the focus is primarily on the mental health patient, the article is of benefit to all health and social care professionals to help them develop an understanding of e-cigarettes as a tobacco-smoking cessation or harm-reduction aid. LEARNING OBJECTIVES: After reading this article you will be able to: • provide a balanced overview of e-cigarette use • understand the risk reduction approach in the use of e-cigarettes versus tobacco smoking in people with mental illness • demonstrate the principles of taking a vaping history. DECLARATION OF INTEREST: S.G. was chief investigator for the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR) (HTA 11/136/52) and is supported by the National Institute for Health Research (NIHR) Yorkshire and Humber Collaboration for Leadership in Applied Health Research and Care (CLAHRC YH). S.K. received an NIHR grant to part fund her research time for SCIMITAR. This article evolved from the SCIMITAR study. [ABSTRACT FROM AUTHOR]

Aims To determine the effectiveness and safety of varenicline in treating tobacco dependence in patients with severe mental illness. Design A systematic reviewand meta-analysis of randomised controlled trials that compared varenicline with a placebo or an alternative intervention for smoking cessation or reduction. Setting Both in- and out-patient settings in any country. Participants Adult patients aged 18 years and over with any type of severe mental illness. The systematic review included eight studies comprising 398 participants. Measures Primary outcome measures were (1) smoking cessation, (2) smoking reduction measured by changes in the number of cigarettes smoked per day and (3) number of psychiatric adverse events, which were collected at the end of treatment. Findings The random-effect pooled estimates from the five studies that reported smoking-related outcomes found that varenicline is statistically superior to placebo in smoking cessation [risk ratios 4.33; 95% confidence interval (CI)=1.96-9.56], and smoking reduction was higher in varenicline groups (mean reduced daily cigarettes was 6.39; 95% CI=2.22-10.56). There is no significant difference regarding neuropsychiatric and other adverse events. Conclusions Varenicline appears to be significantly more effective than placebo in assisting with smoking cessation and reduction in people with severe mental illness. There appears to be no clear evidence that varenicline was associated with an increased risk of neuropsychiatric or other adverse events compared with placebo. [ABSTRACT FROM AUTHOR]