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

Gilbody, Simon; Peckham, Emily; Man, Mei-See; Mitchell, Natasha; Li, Jinshuo; Becque, Taeko; Hewitt, Catherine; Knowles, Sarah; Bradshaw, Tim; Planner, Claire; Parrott, Steve; Michie, Susan; Shepherd, Charles

doi:10.1016/s2215-0366(15)00091-7

Cited by 74 publications

(94 citation statements)

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“…Specialised group programme + NRT patch*21 mg for 6 weeks then 14 mg for 2 weeks then 7md for 2 weeksALA group consisted of 3 weekly 60 min manualised sessions of group counsellingSpecialised programme consisted of 3 weeks of 1 h motivational enhancement then 7 weeks 1 h of psychoeducation. All manualised7 day point prevalence abstinence at week 10, and 26 verified by expired CO <10 ppm.Continuous abstinence in last 4 weeks of treatmentChange in psychiatric symptoms (AIMS, BDI, PANSS, WEPS)Gilbody 2015 [33]RCT97 adult outpatients with DSM IV schizophrenia, schizoaffective disorder or bipolar disorder who expressed a desire to cut down or quit smoking and smoked ≥10 cigarettes per day. England 60% male, 87% white.1.…”

Section: Resultsmentioning

confidence: 99%

“…Five studies explored the effects of a smoking cessation programme designed for people with SMI (638 participants): two studies compared the smoking cessation programme to usual care [18, 33], one explored a specialist programme plus NRT versus a standard smoking programme plus NRT [12], one study compared a specialist programme with medication management [23], and one study compared motivational interviewing with personalised feedback with interactive education with no personalisation [36]. …”

Section: Resultsmentioning

confidence: 99%

“…Change in BMI was not routinely measured in the included studies and only two studies listed BMI as one of their outcomes [31, 33]. Of these only one study reported change in BMI therefore no meta-analysis was conducted.…”

Section: Resultsmentioning

confidence: 99%

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Smoking cessation in severe mental ill health: what works? an updated systematic review and meta-analysis

et al. 2017

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BackgroundPeople 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.MethodsThis 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).ResultsWe 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.ConclusionsBupropion 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-017-1419-7) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Smoking cessation in severe mental ill health: what works? an updated systematic review and meta-analysis

et al. 2017

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“…- Example 1 (using the words pilot, randomised, and trial) − “Bespoke smoking cessation for people with severe mental ill health (SCIMITAR): a pilot randomised controlled trial” [31] …”

Section: Extension Of Consort 2010 To Pilot Trialsmentioning

confidence: 99%

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge

Chan

Campbell

et al. 2016

Pilot Feasibility Stud

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The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply.The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist.The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number.This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials.Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users.

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“…Bennett et al (2013) reviewed 11 studies that investigated psychosocial/behavioural approaches in people with schizophrenia and concluded there were reasonable short-term abstinence rates but data were too variable to determine clear long-term effects. A recently reported UK pilot RCT of a bespoke smoking cessation programme for people with psychosis (SCIMITAR), compared to usual care, suggested that the bespoke programme resulted in greater effectiveness (Gilbody et al, 2015). This is being followed up by a full trial.…”

Section: Interventions For Tobacco Smokingmentioning

confidence: 99%

BAP guidelines on the management of weight gain, metabolic disturbances and cardiovascular risk associated with psychosis and antipsychotic drug treatment

et al. 2016

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Excess deaths from cardiovascular disease are a major contributor to the significant reduction in life expectancy experienced by people with schizophrenia. Important risk factors in this are smoking, alcohol misuse, excessive weight gain and diabetes. Weight gain also reinforces service users' negative views of themselves and is a factor in poor adherence with treatment. Monitoring of relevant physical health risk factors is frequently inadequate, as is provision of interventions to modify these. These guidelines review issues surrounding monitoring of physical health risk factors and make recommendations about an appropriate approach. Overweight and obesity, partly driven by antipsychotic drug treatment, are important factors contributing to the development of diabetes and cardiovascular disease in people with schizophrenia. There have been clinical trials of many interventions for people experiencing weight gain when taking antipsychotic medications but there is a lack of clear consensus regarding which may be appropriate in usual clinical practice. These guidelines review these trials and make recommendations regarding appropriate interventions. Interventions for smoking and alcohol misuse are reviewed, but more briefly as these are similar to those recommended for the general population. The management of impaired fasting glycaemia and impaired glucose tolerance ('pre-diabetes'), diabetes and other cardiovascular risks, such as dyslipidaemia, are also reviewed with respect to other currently available guidelines.These guidelines were compiled following a consensus meeting of experts involved in various aspects of these problems. They reviewed key areas of evidence and their clinical implications. Wider issues relating to primary care/secondary care interfaces are discussed but cannot be resolved within guidelines such as these.

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

Abstract: National Institute of Health Research Health Technology Assessment Programme.

Cited by 74 publications

References 24 publications

Smoking cessation in severe mental ill health: what works? an updated systematic review and meta-analysis

Smoking cessation in severe mental ill health: what works? an updated systematic review and meta-analysis

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

BAP guidelines on the management of weight gain, metabolic disturbances and cardiovascular risk associated with psychosis and antipsychotic drug treatment

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