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A bespoke smoking cessation service compared with treatment as usual for people with severe mental ill health: the SCIMITAR+ RCT

Peckham, Emily; Arundel, Catherine; Bailey, Della; Crosland, Suzanne; Fairhurst, Caroline; Heron, Paul; Hewitt, Catherine; Li, Jinshuo; Parrott, Steve; Bradshaw, Tim; Horspool, Michelle; Hughes, Elizabeth; Hughes, Tom; Ker, Suzy; Leahy, Moira; McCloud, Tayla; Osborn, David; Reilly, Joseph; Steare, Thomas; Ballantyne, Emma; Bidwell, Polly; Bonner, Susan; Brennan, Diane; Callen, Tracy; Carey, Alex; Colbeck, Charlotte; Coton, Debbie; Donaldson, Emma; Evans, Kimberley; Herlihy, Hannah; Khan, Wajid; Nyathi, Lizwi; Nyamadzawo, Elizabeth; Oldknow, Helen; Phiri, Peter; Rathod, Shanaya; Rea, Jamie; Romain-Hooper, Crystal-Bella; Smith, Kaye; Stribling, Alison; Vickers, Carinna; Gilbody, Simon

Authors

Emily Peckham

Catherine Arundel

Della Bailey

Suzanne Crosland

Caroline Fairhurst

Paul Heron

Catherine Hewitt

Jinshuo Li

Steve Parrott

Tim Bradshaw

Michelle Horspool

Elizabeth Hughes

Tom Hughes

Suzy Ker

Moira Leahy

Tayla McCloud

David Osborn

Joseph Reilly

Thomas Steare

Emma Ballantyne

Polly Bidwell

Susan Bonner

Diane Brennan

Tracy Callen

Alex Carey

Charlotte Colbeck

Debbie Coton

Emma Donaldson

Kimberley Evans

Hannah Herlihy

Wajid Khan

Lizwi Nyathi

Elizabeth Nyamadzawo

Helen Oldknow

Peter Phiri

Shanaya Rathod

Jamie Rea

Crystal-Bella Romain-Hooper

Kaye Smith

Alison Stribling

Carinna Vickers

Simon Gilbody



Abstract

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.

Journal Article Type Article
Acceptance Date Sep 1, 2019
Publication Date 2019-09
Deposit Date Feb 1, 2022
Publicly Available Date Feb 2, 2022
Journal Health Technology Assessment
Print ISSN 1366-5278
Electronic ISSN 2046-4924
Publisher NIHR Journals Library
Peer Reviewed Peer Reviewed
Volume 23
Issue 50
Pages 1-116
DOI https://doi.org/10.3310/hta23500
Keywords Health Policy
Public URL http://researchrepository.napier.ac.uk/Output/2839823

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