{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T13:35:47Z","timestamp":1785764147294,"version":"3.56.0"},"reference-count":40,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2025,6,19]],"date-time":"2025-06-19T00:00:00Z","timestamp":1750291200000},"content-version":"unspecified","delay-in-days":18,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100024749","name":"National Institute for Health Research Applied Research Collaboration East of England","doi-asserted-by":"publisher","award":["NIHR200607"],"award-info":[{"award-number":["NIHR200607"]}],"id":[{"id":"10.13039\/501100024749","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,6,2]]},"published-print":{"date-parts":[[2025,6]]},"abstract":"\n Introduction<\/jats:title>\n Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smoke-free mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (\u226518 years) admitted to an acute adult mental health inpatient setting who smoke tobacco on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3\u2009months and a second timepoint between 4 and 6 months post-randomisation. With 64 participants (32 in each group), the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% CI of \u00b13%\u2009and \u00b110%, respectively. The analysis will be descriptive and follow a prespecified plan.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n \n Ethics approval was obtained from the North West\u2014Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and patient and public involvement networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website:\n https:\/\/sceptreresearch.com\/<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n ISRCTN77855199<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-094441","type":"journal-article","created":{"date-parts":[[2025,6,19]],"date-time":"2025-06-19T06:58:06Z","timestamp":1750316286000},"page":"e094441","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Promoting smoking cessation and preventing relapse to tobacco use following a smoke-free mental health inpatient stay (SCEPTRE feasibility study): a multicentre randomised controlled feasibility study protocol"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"isrctn77855199","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5535-2458","authenticated-orcid":false,"given":"Petal","family":"Petersen Williams","sequence":"first","affiliation":[{"name":"Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK"},{"name":"Mental Health, Alcohol, Substance Use and Tobacco Research Unit, South African Medical Research Council, Tygerberg, Cape Town, South Africa"},{"name":"Institute for Life Course Health Research, Department of Global Health, University of Stellenbosch, Stellenbosch, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Huddlestone","sequence":"additional","affiliation":[{"name":"Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Shoesmith","sequence":"additional","affiliation":[{"name":"Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7763-2776","authenticated-orcid":false,"given":"Samantha","family":"Brady","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9311-2092","authenticated-orcid":false,"given":"Alex","family":"Mitchell","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria","family":"Exley","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fraser","family":"Wiggins","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lesley","family":"Sinclair","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jodi","family":"Pervin","sequence":"additional","affiliation":[{"name":"Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Horspool","sequence":"additional","affiliation":[{"name":"Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moira","family":"Leahy","sequence":"additional","affiliation":[{"name":"Sheffield Health and Social Care NHS Foundation Trust, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"Paul","sequence":"additional","affiliation":[{"name":"Leeds and York Partnership NHS Foundation Trust, Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lesley","family":"Colley","sequence":"additional","affiliation":[{"name":"Tees, Esk and Wear Valleys NHS Foundation Trust, Darlington, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lion","family":"Shahab","sequence":"additional","affiliation":[{"name":"Department of Behavioural Science and Health, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0694-3854","authenticated-orcid":false,"given":"Judith","family":"Watson","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Hewitt","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Hough","sequence":"additional","affiliation":[{"name":"Independent PPI Co-applicant, Cheshire, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Britton","sequence":"additional","affiliation":[{"name":"Division of Epidemiology, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim","family":"Coleman","sequence":"additional","affiliation":[{"name":"Centre for Academic Primary Care, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Gilbody","sequence":"additional","affiliation":[{"name":"Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK"},{"name":"Hull York Medical School, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steve","family":"Parrott","sequence":"additional","affiliation":[{"name":"Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3185-205X","authenticated-orcid":false,"given":"Paul","family":"Galdas","sequence":"additional","affiliation":[{"name":"Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregor","family":"Russell","sequence":"additional","affiliation":[{"name":"Research and Development, Bradford District Care NHS Foundation Trust, Bradford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter A","family":"Coventry","sequence":"additional","affiliation":[{"name":"Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK"},{"name":"York Environmental Sustainability Institute, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Ratschen","sequence":"additional","affiliation":[{"name":"Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,6,19]]},"reference":[{"key":"2025121523521025000_15.6.e094441.1","unstructured":"NHS Digital . Statistics on smoking, England 2020. 2020. Available: https:\/\/digital.nhs.uk\/data-and-information\/publications\/statistical\/statistics-on-smoking\/statistics-on-smoking-england-2020\/part-1-smoking-related-ill-health-and-mortality [Accessed 08 Aug 2023]."},{"key":"2025121523521025000_15.6.e094441.2","unstructured":"NHS Digital . Statistics on smoking, England - 2016. 2016."},{"key":"2025121523521025000_15.6.e094441.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.addbeh.2018.10.011"},{"key":"2025121523521025000_15.6.e094441.4","unstructured":"Royal College of Psychiatrists, Royal College of Psychiatrists . Smoking and mental health. London, 2013."},{"key":"2025121523521025000_15.6.e094441.5","doi-asserted-by":"publisher","DOI":"10.1080\/0954026021000046047"},{"key":"2025121523521025000_15.6.e094441.6","unstructured":"Harker HH , Cheeseman H . The stolen years: the mental health and smoking action report 2016. London, 2016."},{"key":"2025121523521025000_15.6.e094441.7","doi-asserted-by":"crossref","DOI":"10.1186\/s12888-017-1419-7","article-title":"Smoking cessation in severe mental ill health: what works? An updated systematic review and meta-analysis","volume":"17","author":"Peckham","year":"2017","journal-title":"BMC Psychiatry"},{"key":"2025121523521025000_15.6.e094441.8","doi-asserted-by":"crossref","DOI":"10.1186\/s12889-020-09308-x","article-title":"Mental health, smoking, harm reduction and quit attempts - a population survey in England","volume":"20","author":"Brose","year":"2020","journal-title":"BMC Public Health"},{"key":"2025121523521025000_15.6.e094441.9","doi-asserted-by":"crossref","DOI":"10.1186\/1472-6963-10-179","article-title":"The delivery of stop smoking support to people with mental health conditions: a survey of NHS stop smoking services","volume":"10","author":"McNally","year":"2010","journal-title":"BMC Health Serv Res"},{"key":"2025121523521025000_15.6.e094441.10","doi-asserted-by":"crossref","DOI":"10.1186\/1472-6963-11-190","article-title":"The prevalence of mental health problems among users of NHS stop smoking services: effects of implementing a routine screening procedure","volume":"11","author":"McNally","year":"2011","journal-title":"BMC Health Serv Res"},{"key":"2025121523521025000_15.6.e094441.11","doi-asserted-by":"crossref","DOI":"10.1186\/s12888-016-0901-y","article-title":"Making the journey with me: a qualitative study of experiences of a bespoke mental health smoking cessation intervention for service users with serious mental illness","volume":"16","author":"Knowles","year":"2016","journal-title":"BMC Psychiatry"},{"key":"2025121523521025000_15.6.e094441.12","doi-asserted-by":"publisher","DOI":"10.3310\/hta19880"},{"key":"2025121523521025000_15.6.e094441.13","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1111\/j.1360-0443.2012.04082.x","article-title":"Tailored tobacco dependence support for mental health patients: a model for inpatient and community services","volume":"107 Suppl 2","author":"Parker","year":"2012","journal-title":"Addiction"},{"key":"2025121523521025000_15.6.e094441.14","unstructured":"NICE . Tobacco: preventing uptake, promoting quitting and treating dependence [NG209]. 2021. Available: https:\/\/www.nice.org.uk\/guidance\/ng209"},{"key":"2025121523521025000_15.6.e094441.15","doi-asserted-by":"crossref","first-page":"669","DOI":"10.1017\/S0033291717002021","article-title":"Maintaining abstinence from smoking after a period of enforced abstinence - systematic review, meta-analysis and analysis of behaviour change techniques with a focus on mental health","volume":"48","author":"Brose","year":"2018","journal-title":"Psychol Med"},{"key":"2025121523521025000_15.6.e094441.16","doi-asserted-by":"crossref","first-page":"2978","DOI":"10.1111\/add.15452","article-title":"Supporting smoking cessation and preventing relapse following a stay in a smoke-free setting: a meta-analysis and investigation of effective behaviour change techniques","volume":"116","author":"Shoesmith","year":"2021","journal-title":"Addiction"},{"key":"2025121523521025000_15.6.e094441.17","doi-asserted-by":"publisher","DOI":"10.1080\/10550490500419011"},{"key":"2025121523521025000_15.6.e094441.18","doi-asserted-by":"crossref","DOI":"10.1016\/j.pmedr.2019.100891","article-title":"Rapid relapse to smoking following hospital discharge","volume":"15","author":"Mussulman","year":"2019","journal-title":"Prev Med Rep"},{"key":"2025121523521025000_15.6.e094441.19","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"},{"key":"2025121523521025000_15.6.e094441.20","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1016\/j.math.2016.03.004","article-title":"Using the template for intervention description and replication (TIDieR) as a tool for improving the design and reporting of manual therapy interventions","volume":"24","author":"Alvarez","year":"2016","journal-title":"Man Ther"},{"key":"2025121523521025000_15.6.e094441.21","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.i5239","article-title":"CONSORT 2010 statement: extension to randomised pilot and feasibility trials","volume":"355","author":"Eldridge","year":"2016","journal-title":"BMJ"},{"key":"2025121523521025000_15.6.e094441.22","first-page":"1010","volume-title":"The behaviour change wheel: a guide to designing interventions","volume":"Vol 1003","author":"Michie","year":"2014"},{"key":"2025121523521025000_15.6.e094441.23","doi-asserted-by":"publisher","DOI":"10.1186\/1748-5908-7-37"},{"key":"2025121523521025000_15.6.e094441.24","doi-asserted-by":"publisher","DOI":"10.1007\/s12160-013-9486-6"},{"key":"2025121523521025000_15.6.e094441.25","doi-asserted-by":"crossref","first-page":"729","DOI":"10.1093\/ntr\/ntac242","article-title":"Promoting and Maintaining Changes in Smoking Behavior for Patients Following Discharge from a Smoke-free Mental Health Inpatient Stay: Development of a Complex Intervention Using the Behavior Change Wheel","volume":"25","author":"Shoesmith","year":"2023","journal-title":"Nicotine Tob Res"},{"key":"2025121523521025000_15.6.e094441.26","doi-asserted-by":"crossref","first-page":"945","DOI":"10.1093\/ntr\/ntac004","article-title":"A Systematic Review of Mental Health Professionals, Patients, and Carers\u2019 Perceived Barriers and Enablers to Supporting Smoking Cessation in Mental Health Settings","volume":"24","author":"Huddlestone","year":"2022","journal-title":"Nicotine Tob Res"},{"key":"2025121523521025000_15.6.e094441.27","unstructured":"Royal College of Psychiatrists, Royal College of Psychiatrists . Smoking and mental health. 2013. Available: https:\/\/www.rcplondon.ac.uk\/projects\/outputs\/smoking-andmental-health [Accessed 23 Nov 2022]."},{"key":"2025121523521025000_15.6.e094441.28","unstructured":"Royal College of Psychiatrists . The prescribing of varencline and vaping (eletronic cigarettes) to patients with severe mental illness. Position Statement (PS05\/18). 2018."},{"key":"2025121523521025000_15.6.e094441.29","doi-asserted-by":"publisher","DOI":"10.1093\/ntr\/ntq038"},{"key":"2025121523521025000_15.6.e094441.30","doi-asserted-by":"publisher","DOI":"10.1111\/j.1360-0443.2010.03226.x"},{"key":"2025121523521025000_15.6.e094441.31","unstructured":"NCSCT . Motivation to stop smoking. n.d. Available: https:\/\/www.ncsct.co.uk\/usr\/pub\/Motivation%20to%20stop%20smoking.pdf"},{"key":"2025121523521025000_15.6.e094441.32","doi-asserted-by":"publisher","DOI":"10.1046\/j.1525-1497.2001.016009606.x"},{"key":"2025121523521025000_15.6.e094441.33","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.166.10.1092"},{"key":"2025121523521025000_15.6.e094441.34","doi-asserted-by":"publisher","DOI":"10.3109\/09638237.2013.779366"},{"key":"2025121523521025000_15.6.e094441.35","doi-asserted-by":"publisher","DOI":"10.1093\/ntr\/ntz132"},{"key":"2025121523521025000_15.6.e094441.36","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1177\/0004867417692424","article-title":"Efficacy of a universal smoking cessation intervention initiated in inpatient psychiatry and continued post-discharge: A randomised controlled trial","volume":"51","author":"Metse","year":"2017","journal-title":"Aust N Z J Psychiatry"},{"key":"2025121523521025000_15.6.e094441.37","doi-asserted-by":"publisher","DOI":"10.1002\/nur.20247"},{"key":"2025121523521025000_15.6.e094441.38","doi-asserted-by":"crossref","DOI":"10.1186\/s40814-019-0423-8","article-title":"A guide to the reporting of protocols of pilot and feasibility trials","volume":"5","author":"Thabane","year":"2019","journal-title":"Pilot Feasibility Stud"},{"key":"2025121523521025000_15.6.e094441.39","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780131703"},{"key":"2025121523521025000_15.6.e094441.40","doi-asserted-by":"crossref","unstructured":"Braun V , Clarke V . Thematic analysis. American Psychological Association, 2012.","DOI":"10.1037\/13620-004"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2024-094441","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T07:52:19Z","timestamp":1765871539000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2024-094441"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6]]},"references-count":40,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2025,6,19]]},"published-print":{"date-parts":[[2025,6]]}},"alternative-id":["10.1136\/bmjopen-2024-094441"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2024-094441","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6]]}}}