title: Bespoke smoking cessation for people with severe mental ill health (SCIMITAR): a pilot randomised controlled trial.
abstract: 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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  National Institute of Health Research Health Technology Assessment Programme.
authors.affiliation: Department of Health Sciences, University of York, York, UK. Electronic address: simon.gilbody@york.ac.uk.
authors.forename: Simon
authors.initials: S
authors.lastname: Gilbody
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Emily
authors.initials: E
authors.lastname: Peckham
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Mei-See
authors.initials: MS
authors.lastname: Man
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Natasha
authors.initials: N
authors.lastname: Mitchell
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Jinshuo
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Taeko
authors.initials: T
authors.lastname: Becque
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hewitt
authors.affiliation: Centre for Primary Care, University of Manchester, Manchester, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Knowles
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Bradshaw
authors.affiliation: Centre for Primary Care, University of Manchester, Manchester, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Planner
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Steve
authors.initials: S
authors.lastname: Parrott
authors.affiliation: Department of Clinical, Educational and Health Psychology, University College London, London, UK.
authors.forename: Susan
authors.initials: S
authors.lastname: Michie
authors.affiliation: Faculty of Health & Social Care, University of Hull, Hull, UK.
authors.forename: Charles
authors.initials: C
authors.lastname: Shepherd
mesh_terms: D000328:Adult; D001714:Bipolar Disorder / Q000523:psychology*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009313:National Health Programs; D010865:Pilot Projects; D012565:Schizophrenic Psychology; D012907:Smoking / Q000523:psychology*; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D006113:United Kingdom