IntEgrating smoking cessation treAtment into usual online psychological care for people with common mEntal illness: Protocol for an online randomised feasibility and pilot study (ESCAPE digital)

Anna K M Blackwell; Shadi Daryan; Deborah Roy; Daniel Duffy; Garrett Hisler; Katherine Sawyer; Ben Ainsworth; Derek Richards; Douglas Hiscock; Sophia Papadakis; Jamie Brown; Marcus R Munafò; Pamela Jacobsen; Paul Aveyard; Gemma Taylor

doi:10.1016/j.cct.2024.107541

IntEgrating smoking cessation treAtment into usual online psychological care for people with common mEntal illness: Protocol for an online randomised feasibility and pilot study (ESCAPE digital)

Contemp Clin Trials. 2024 Apr 21:141:107541. doi: 10.1016/j.cct.2024.107541. Online ahead of print.

Authors

Anna K M Blackwell¹, Shadi Daryan², Deborah Roy³, Daniel Duffy⁴, Garrett Hisler⁵, Katherine Sawyer⁶, Ben Ainsworth⁷, Derek Richards⁸, Douglas Hiscock⁹, Sophia Papadakis¹⁰, Jamie Brown¹¹, Marcus R Munafò¹², Pamela Jacobsen¹³, Paul Aveyard¹⁴, Gemma Taylor¹⁵

Affiliations

¹ Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath BA2 7AY, UK. Electronic address: akmb22@bath.ac.uk.
² Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath BA2 7AY, UK. Electronic address: sd498@bath.ac.uk.
³ Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath BA2 7AY, UK. Electronic address: dr321@bath.ac.uk.
⁴ Amwell, 1 Stephen St Upper, Dublin 8 D08 DR9P, Ireland. Electronic address: daniel.duffy@amwell.com.
⁵ Amwell, 1 Stephen St Upper, Dublin 8 D08 DR9P, Ireland. Electronic address: garrett.hisler@amwell.com.
⁶ Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath BA2 7AY, UK. Electronic address: ksls20@bath.ac.uk.
⁷ School of Psychology, University of Southampton, B44, West Highfield Campus, University Road, SO17 1BJ, UK. Electronic address: ben.ainsworth@southampton.ac.uk.
⁸ Amwell, 1 Stephen St Upper, Dublin 8 D08 DR9P, Ireland; School of Psychology, University of Dublin, Trinity College, Dublin D02 PN40, Ireland. Electronic address: d.richards@tcd.ie.
⁹ Amwell, 1 Stephen St Upper, Dublin 8 D08 DR9P, Ireland. Electronic address: hiscock@amwell.com.
¹⁰ National Centre for Smoking Cessation and Training, Dorchester, Dorset DT1 1RD, UK. Electronic address: sophia@ncsct.co.uk.
¹¹ Department of Behavioural Science and Health, University College London, London WC1E 6BT, UK. Electronic address: jamie.brown@ucl.ac.uk.
¹² MRC Integrative Epidemiology Unit, School of Psychological Science, University of Bristol, 12a Priory Road, Bristol BS8 1TU, UK. Electronic address: marcus.munafo@bristol.ac.uk.
¹³ Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath BA2 7AY, UK. Electronic address: pcj25@bath.ac.uk.
¹⁴ Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK. Electronic address: paul.aveyard@phc.ox.ac.uk.
¹⁵ Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath BA2 7AY, UK. Electronic address: gmjm20@bath.ac.uk.

PMID: 38643854
DOI: 10.1016/j.cct.2024.107541

Abstract

Background: In the UK, smoking prevalence in people with depression (34%) and anxiety (29%) is more than double that of the general population (13%). People who stop smoking improve their mental health with comparable effect sizes found for antidepressants. In England, online psychological therapy is a standard treatment for depression and anxiety. Online therapy is an acceptable setting for smoking cessation support; however, integrated smoking and mental health support is not available. This novel study aims to assess the acceptability and feasibility of an online smoking cessation intervention, and trial procedures, offered alongside online mental health treatment as it offers increased reach to people with common mental health difficulties who smoke.

Methods: A two-armed; Intervention (Integrated SilverCloud smoking cessation support) and control group (SilverCloud usual care), pragmatic, randomised controlled feasibility trial. We aim to recruit 500 adult smokers eligible for online mental health treatment. Follow-up will be conducted at 3-months and 6-months. We will assess the acceptability and feasibility of the trial procedures (i.e., recruitment, data completeness, self-reported acceptability and satisfaction) and the intervention (i.e., self-reported quit attempt, engagement with the smoking cessation and mental health programs, smoking cessation medicine and e-cigarette use, self-reported acceptability and satisfaction) and pilot clinical outcomes (i.e., biologically validated smoking abstinence, anxiety, depression, quality of health).

Conclusion: If the Trial is successful, a randomised controlled effectiveness trial will follow to examine whether integrated smoking cessation and mental health treatment increases smoking abstinence and improves depression and anxiety compared to usual care.

Trial registration: ISRCTN10612149 (https://doi.org/10.1186/ISRCTN10612149), 02/02/2023.

Keywords: Anxiety; Depression; Digital intervention; Mental health; Smoking cessation; Tobacco.