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

Introduction 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 smo...

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Main Authors: Simon Gilbody, Catherine Hewitt, John Britton, Lion Shahab, Tim Coleman, Elena Ratschen, Judith Watson, Alex Mitchell, Gregor Russell, Steve Parrott, Lesley Sinclair, Peter A Coventry, Paul Galdas, Michelle Horspool, Samantha Brady, Emily Shoesmith, Petal Petersen Williams, Lisa Huddlestone, Victoria Exley, Fraser Wiggins, Jodi Pervin, Moira Leahy, Claire Paul, Lesley Colley, Simon Hough
Format: Article
Language:English
Published: BMJ Publishing Group 2025-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/6/e094441.full
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author Simon Gilbody
Catherine Hewitt
John Britton
Lion Shahab
Tim Coleman
Elena Ratschen
Judith Watson
Alex Mitchell
Gregor Russell
Steve Parrott
Lesley Sinclair
Peter A Coventry
Paul Galdas
Michelle Horspool
Samantha Brady
Emily Shoesmith
Petal Petersen Williams
Lisa Huddlestone
Victoria Exley
Fraser Wiggins
Jodi Pervin
Moira Leahy
Claire Paul
Lesley Colley
Simon Hough
author_facet Simon Gilbody
Catherine Hewitt
John Britton
Lion Shahab
Tim Coleman
Elena Ratschen
Judith Watson
Alex Mitchell
Gregor Russell
Steve Parrott
Lesley Sinclair
Peter A Coventry
Paul Galdas
Michelle Horspool
Samantha Brady
Emily Shoesmith
Petal Petersen Williams
Lisa Huddlestone
Victoria Exley
Fraser Wiggins
Jodi Pervin
Moira Leahy
Claire Paul
Lesley Colley
Simon Hough
author_sort Simon Gilbody
collection DOAJ
description Introduction 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.Methods and analysis This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 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 months 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 ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.Ethics and dissemination Ethics approval was obtained from the North West—Greater 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: https://sceptreresearch.com/.Trial registration number ISRCTN77855199.
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spelling doaj-art-e5b763f2d9234f6392004da92ba9ec272025-08-20T03:30:35ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2024-094441Promoting 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 protocolSimon Gilbody0Catherine Hewitt1John Britton2Lion Shahab3Tim Coleman4Elena Ratschen5Judith Watson6Alex Mitchell7Gregor Russell8Steve Parrott9Lesley Sinclair10Peter A Coventry11Paul Galdas12Michelle Horspool13Samantha Brady14Emily Shoesmith15Petal Petersen Williams16Lisa Huddlestone17Victoria Exley18Fraser Wiggins19Jodi Pervin20Moira Leahy21Claire Paul22Lesley Colley23Simon Hough24Hull York Medical School, University of York, York, UKYork Trials Unit, Department of Health Sciences, University of York, York, UKDivision of Epidemiology, University of Nottingham, Nottingham, UKDepartment of Behavioural Science and Health, University College London, London, UKCentre for Academic Primary Care, University of Nottingham, Nottingham, UKMental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UKYork Trials Unit, Department of Health Sciences, University of York, York, UKYork Trials Unit, Department of Health Sciences, University of York, York, UKResearch and Development, Bradford District Care NHS Foundation Trust, Bradford, UKMental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UKYork Trials Unit, Department of Health Sciences, University of York, York, UKMental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UKMental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UKSheffield Health and Social Care NHS Foundation Trust, Sheffield, UKYork Trials Unit, Department of Health Sciences, University of York, York, UKMental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UKMental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UKMental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UKYork Trials Unit, Department of Health Sciences, University of York, York, UKYork Trials Unit, Department of Health Sciences, University of York, York, UKMental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UKSheffield Health and Social Care NHS Foundation Trust, Sheffield, UKLeeds and York Partnership NHS Foundation Trust, Leeds, UKTees, Esk and Wear Valleys NHS Foundation Trust, Darlington, UKIndependent PPI Co-applicant, Cheshire, UKIntroduction 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.Methods and analysis This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 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 months 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 ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.Ethics and dissemination Ethics approval was obtained from the North West—Greater 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: https://sceptreresearch.com/.Trial registration number ISRCTN77855199.https://bmjopen.bmj.com/content/15/6/e094441.full
spellingShingle Simon Gilbody
Catherine Hewitt
John Britton
Lion Shahab
Tim Coleman
Elena Ratschen
Judith Watson
Alex Mitchell
Gregor Russell
Steve Parrott
Lesley Sinclair
Peter A Coventry
Paul Galdas
Michelle Horspool
Samantha Brady
Emily Shoesmith
Petal Petersen Williams
Lisa Huddlestone
Victoria Exley
Fraser Wiggins
Jodi Pervin
Moira Leahy
Claire Paul
Lesley Colley
Simon Hough
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
BMJ Open
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://bmjopen.bmj.com/content/15/6/e094441.full
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