Smoking cessation for people with severe mental illness (SCIMITAR): a pragmatic randomised controlled trial
Open accessAbstract
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
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Smoking is a leading cause of the 15 to 30 year premature mortality associated with severe mental illness.
“as smoking is a leading cause of the 15 to 30 year premature mortality associated with severe mental illness 100 .”
From A meta-review of "lifestyle psychiatry": the role of exercise, smoking, diet and sleep in the prevention and treatment of mental disorders (2020) · cites this paper as [100]
The Introduction says people with severe mental illness die on average 20–25 years earlier and identifies smoking as the most important modifiable risk factor for that inequality. It does not support the wider 15–30-year range stated in the claim. (LLM, conf=0.85)
Experimental — accuracy not yet measuredSmoking cessation treatments, such as nicotine replacement therapy, varenicline and bupropion, are well-established, safe and effective interventions.
“Smoking cessation treatments, such as nicotine replacement therapy, varenicline and bupropion are well-established, safe and effective interventions (Gilbody et al., 2019; Peckham et al., 2017).”
From The impact of cigarette smoking on life expectancy in schizophrenia, schizoaffective disorder and bipolar affective disorder: An electronic case register cohort study (2021) · cites this paper as Gilbody et al., 2019
User engagement may be lower in actual clinical care than in trial settings.
“User engagement may be lower in actual clinical care that in trial settings.334,335”
From The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness (2019) · cites this paper as [334]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
A Brief Measure for Assessing Generalized Anxiety Disorder: The GAD-7
Spitzer, R. L., Kroenke, K., Williams, J. B. W., & Löwe, B. (2006) · Archives of Internal Medicine · doi:10.1001/archinte.166.10.1092 · Cited by 31,765 · see citing works
EuroQol: a new facility for the measurement of health-related quality of life
(1990) · Health Policy · doi:10.1016/0168-8510(90)90421-9 · Cited by 15,736 · see citing works
The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire
HEATHERTON, T. F., KOZLOWSKI, L. T., FRECKER, R. C., & FAGERSTROM, K. (1991) · British Journal of Addiction · doi:10.1111/j.1360-0443.1991.tb01879.x · Cited by 10,738 · see citing works
Multiple imputation using chained equations: Issues and guidance for practice
White, I. R., Royston, P., & Wood, A. M. (2011) · Statistics in Medicine · doi:10.1002/sim.4067 · Cited by 9,792 · see citing works
Outcome criteria in smoking cessation trials: proposal for a common standard
West, R., Hajek, P., Stead, L., & Stapleton, J. (2005) · Addiction · doi:10.1111/j.1360-0443.2004.00995.x · Cited by 1,285 · see citing works
Anthenelli, R. M., Benowitz, N. L., West, R., St Aubin, L., McRae, T., Lawrence, D., Ascher, J., Russ, C., Krishen, A., & Evins, A. E. (2016) · The Lancet · doi:10.1016/s0140-6736(16)30272-0 · Cited by 1,177 · see citing works
Change in mental health after smoking cessation: systematic review and meta-analysis
Taylor, G., McNeill, A., Girling, A., Farley, A., Lindson-Hawley, N., & Aveyard, P. (2014) · BMJ · doi:10.1136/bmj.g1151 · Cited by 1,039 · see citing works
Combined pharmacotherapy and behavioural interventions for smoking cessation
Stead, L. F., Koilpillai, P., Fanshawe, T. R., & Lancaster, T. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008286.pub3 · Cited by 829 · see citing works
Understanding controlled trials: What are pragmatic trials?
Roland, M. O., & Torgerson, D. J. (1998) · BMJ · doi:10.1136/bmj.316.7127.285 · Cited by 704 · see citing works
Twenty-five year mortality of a community cohort with schizophrenia
Brown, S., Kim, M., Mitchell, C., & Inskip, H. (2010) · British Journal of Psychiatry · doi:10.1192/bjp.bp.109.067512 · Cited by 601 · see citing works
Cook, B. L., Wayne, G. F., Kafali, E. N., Liu, Z., Shu, C., & Flores, M. (2014) · JAMA · doi:10.1001/jama.2013.284985 · Cited by 519 · see citing works
McNeill, A. D., Brose, L. S., Calder, R. I., Bauld, L., & Robson, D. (2018) · Cited by 350 · see citing works
Smoking cessation in severe mental illness: what works?
Banham, L., & Gilbody, S. (2010) · Addiction · doi:10.1111/j.1360-0443.2010.02946.x · Cited by 243 · see citing works
Self-citationGilbody, S. M., Richards, D. A., & Barkham, M. (2007) · Europe PMC (PubMed Central) · Cited by 206 · see citing works
Self-citationGunnell, D., Irvine, D., Wise, L., Davies, C., & Martin, R. M. (2009) · BMJ · doi:10.1136/bmj.b3805 · Cited by 200 · see citing works
Weiser, M., Reichenberg, A., Grotto, I., Yasvitzky, R., Rabinowitz, J., Lubin, G., Nahon, D., Knobler, H. Y., & Davidson, M. (2004) · American Journal of Psychiatry · doi:10.1176/appi.ajp.161.7.1219 · Cited by 171 · see citing works
Peckham, E., Brabyn, S., Cook, L., Tew, G., & Gilbody, S. (2017) · BMC Psychiatry · doi:10.1186/s12888-017-1419-7 · Cited by 169 · see citing works
Self-citationProchaska, J. J., Hall, S. E., Delucchi, K., & Hall, S. M. (2014) · American Journal of Public Health · doi:10.2105/ajph.2013.301403 · Cited by 149 · see citing works
Williams, J. M., Ziedonis, D. M., Abanyie, F. A., Steinberg, M. L., Foulds, J., & Benowitz, N. L. (2005) · Schizophrenia Research · doi:10.1016/j.schres.2005.04.016 · Cited by 148 · see citing works
Diverging trends in smoking behaviors according to mental health status
Szatkowski, L., & McNeill, A. (2015) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntu173 · Cited by 137 · see citing works
Wang, D., Connock, M., Barton, P., Fry-Smith, A., Aveyard, P., & Moore, D. (2008) · Health Technology Assessment · doi:10.3310/hta12020 · Cited by 137 · see citing works
British National Formulary (BNF)
Thompson, D. (2005) · Cited by 112 · see citing works
Readiness to Stop Smoking in Schizophrenia
Addington, J., el‐Guebaly, N., Addington, D. E., & Hodgins, D. C. (1997) · The Canadian Journal of Psychiatry · doi:10.1177/070674379704200107 · Cited by 112 · see citing works
Performance of English stop smoking services in first 10 years: analysis of service monitoring data
West, R., May, S., West, M., Croghan, E., & McEwen, A. (2013) · BMJ · doi:10.1136/bmj.f4921 · Cited by 103 · see citing works
Evidence about electronic cigarettes: a foundation built on rock or sand?
McKee, M., & Capewell, S. (2015) · BMJ · doi:10.1136/bmj.h4863 · Cited by 95 · see citing works
Measuring readiness and motivation to quit smoking among women in public health clinics
Crittenden, K. S., Manfredi, C., Lacey, L., Warnecke, R. B., & Parsons, J. (1994) · Addictive Behaviors · doi:10.1016/0306-4603(94)90005-1 · Cited by 91 · see citing works
Gilbody, S. M., Peckham, E. J., Man, M., Mitchell, N., Li, J., Becque, T., Hewitt, C. E., Knowles, S. E., Bradshaw, T., Planner, C., et al. (2015) · The Lancet Psychiatry · doi:10.1016/s2215-0366(15)00091-7 · Cited by 79 · see citing works
Self-citationTsoi, D. T.-Y., Porwal, M., & Webster, A. C. (2010) · The British Journal of Psychiatry · doi:10.1192/bjp.bp.109.066019 · Cited by 78 · see citing works
Burki, T. K. (2016) · The Lancet Respiratory Medicine · doi:10.1016/s2213-2600(16)30109-6 · Cited by 70 · see citing works
Manual of Smoking Cessation: A Guide for Counsellors and Practitioners
Peric, T. (2007) · International Journal of Mental Health and Addiction · doi:10.1007/s11469-007-9141-1 · Cited by 60 · see citing works
Stockings, E., Bowman, J., Baker, A., Terry, M., Clancy, R., Wye, P. M., Knight, J., Moore, L., Adams, M., Colyvas, K., et al. (2014) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntu097 · Cited by 57 · see citing works
The delivery of smoking cessation interventions to primary care patients with mental health problems
Szatkowski, L. C., & McNeill, A. D. (2013) · Addiction · doi:10.1111/add.12163 · Cited by 56 · see citing works
Parker, C. H., McNeill, A. D., & Ratschen, E. (2012) · Addiction · doi:10.1111/j.1360-0443.2012.04082.x · Cited by 40 · see citing works
Wu, Q., Gilbody, S. M., Peckham, E. J., Brabyn, S., & Parrott, S. (2016) · Addiction · doi:10.1111/add.13415 · Cited by 39 · see citing works
Self-citationPeckham, E. J., Man, M., Mitchell, N., Li, J., Becque, T., Knowles, S. E., Bradshaw, T., Planner, C., Parrott, S., Michie, S., et al. (2015) · Health Technology Assessment · doi:10.3310/hta19250 · Cited by 31 · see citing works
Self-citationEvaluation of a community-based smoking cessation programme for people with severe mental illness
Ashton, M., Rigby, A., & Galletly, C. (2015) · Tobacco Control · doi:10.1136/tobaccocontrol-2013-051179 · Cited by 25 · see citing works
McNally, L. M., & Ratschen, E. (2010) · BMC Health Services Research · doi:10.1186/1472-6963-10-179 · Cited by 25 · see citing works
Peckham, E. J., Arundel, C., Bailey, D., Brownings, S., Fairhurst, C. M., Heron, P., Li, J., Parrott, S., & Gilbody, S. M. (2017) · Trials · doi:10.1186/s13063-017-1789-7 · Cited by 17 · see citing works
Self-citationHelping people with serious mental illness to cut down or stop smoking
Bradshaw, T., Davies, E., Stronach, M., et al. (2014) · Mental Health Practice · doi:10.7748/mhp2014.03.17.6.14.e890 · Cited by 10 · see citing works
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Firth, J., Solmi, M., Wootton, R. E., Vancampfort, D., Schuch, F. B., Hoare, E., Gilbody, S., Torous, J., Teasdale, S. B., Jackson, S. E., et al. (2020) · World Psychiatry · doi:10.1002/wps.20773 · Cited by 1,148 · see citing works
Self-citationCardiovascular disease in patients with severe mental illness
Nielsen, R. E., Banner, J., & Jensen, S. E. (2021) · Nature Reviews Cardiology · doi:10.1038/s41569-020-00463-7 · Cited by 389 · see citing works
Chesney, E., Robson, D., Patel, R., Shetty, H., Richardson, S., Chang, C.-K., McGuire, P., & McNeill, A. (2021) · Schizophrenia Research · doi:10.1016/j.schres.2021.09.006 · Cited by 45 · see citing works
Spanakis, P., Peckham, E., Young, B., Heron, P., Bailey, D., & Gilbody, S. (2022) · Addiction · doi:10.1111/add.15724 · Cited by 30 · see citing works
Daumit, G. L., Evins, A. E., Cather, C., Dalcin, A. T., Dickerson, F. B., Miller, E. R., Appel, L. J., Jerome, G. J., McCann, U., Ford, D. E., et al. (2023) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2023.1691 · Cited by 13 · see citing works
Anthenelli, R. M., McKenna, B. S., Giannini, J., Attaluri, S. V., Rubin, M., O’Crowley, E., Miller, S., & Heffner, J. L. (2023) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2023.111012 · Cited by 2 · see citing works
- Authors
- Gilbody, S., Peckham, E., Bailey, D., Arundel, C., Heron, P., Crosland, S., Fairhurst, C., Hewitt, C., Li, J., Parrott, S., Bradshaw, T., Horspool, M., Hughes, E., Hughes, T., Ker, S., Leahy, M., McCloud, T., Osborn, D., Reilly, J., Steare, T., Ballantyne, E., Bidwell, P., Bonner, S., Brennan, D., Callen, T., Carey, A., Colbeck, C., Coton, D., Donaldson, E., Evans, K., Herlihy, H., Khan, W., Nyathi, L., Nyamadzawo, E., Oldknow, H., Phiri, P., Rathod, S., Rea, J., Romain-Hooper, C.-B., Smith, K., Stribling, A., & Vickers, C.
- Affiliations
- University of York (GB)
- University of Manchester (GB)
- Sheffield Health and Social Care NHS Foundation Trust (GB)
- University of Leeds (GB)
- Leeds and York Partnership NHS Foundation Trust (GB)
- Tees, Esk and Wear Valleys NHS Foundation Trust (GB)
- University College London (GB)
- Lancashire Care NHS Foundation Trust (GB)
- Lincolnshire Partnership NHS Foundation Trust (GB)
- Solent NHS Trust (GB)
- Sussex Partnership NHS Foundation Trust (GB)
- Berkshire Healthcare NHS Foundation Trust (GB)
- Bradford District Care NHS Foundation Trust (GB)
- Kent and Medway NHS and Social Care Partnership Trust (GB)
- Southern Health NHS Foundation Trust (GB)
- Cumbria Northumberland Tyne and Wear NHS Foundation Trust (GB)
- Cambridgeshire and Peterborough NHS Foundation Trust (GB)
- Somerset Partnership NHS Foundation Trust (GB)
- Corresponding author
- Gilbody, Simon
- ORCID
- Gilbody, Simon
- Peckham, Emily
- Bailey, Della
- Arundel, Catherine
- Crosland, Suzanne
- Fairhurst, Caroline
- Hewitt, Catherine
- Li, Jinshuo
- Parrott, Steve
- Bradshaw, Tim
- Horspool, Michelle
- Hughes, Elizabeth
- Hughes, Tom
- Ker, Suzy
- Leahy, Moira
- McCloud, Tayla
- Osborn, David
- Steare, Thomas
- Ballantyne, Emma
- Callen, Tracy
- Colbeck, Charlotte
- Coton, Debbie
- Donaldson, Emma
- Herlihy, Hannah
- Khan, Wajid
- Nyathi, Lizwi
- Nyamadzawo, Elizabeth
- Oldknow, Helen
- Phiri, Peter
- Rathod, Shanaya
- Rea, Jamie
- Romain-Hooper, Crystal-Bella
- Stribling, Alison
- Vickers, Carinna
- Venue
- The Lancet Psychiatry
- Publisher
- Elsevier BV
- Published
- 2019-05
- Volume
- 6
- Issue
- 5
- Pages
- 379-390
- ISSN
- 2215-0366 (ISSN-L)
- PMC
- PMC6546931
- OpenAlex
- W2936984225
- Cited by
- 207
- References
- 39
- Citations by year
- 2026: 15 · 2025: 24 · 2024: 26 · 2023: 35 · 2022: 31 · 2021: 30 · 2020: 33 · 2019: 13
- FWCI
- 18.35
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Lancet Psychiatry (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion, other-oa)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- National Institute for Health Research
- Health Technology Assessment Programme (11/136/52)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
- Keywords
- smoking cessation, severe mental illness, schizophrenia, bipolar disorder, nicotine dependence, behavioral support, pharmacotherapy, nicotine replacement therapy, varenicline, bupropion, health disparities, primary care, mental health services, carbon monoxide measurement, motivation to quit, anxiety, body mass index, scimitar, usual care comparison, home visits
- MeSH terms
- Adult, Bipolar Disorder, Female, United Kingdom, Humans, Male, Middle Aged, Schizophrenia, Smoking, Smoking Cessation, Treatment Outcome, Self Report
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
