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; Debbie Roy; Daniel Duffy; Garrett Hisler; Katherine Sawyer; Ben Ainsworth; Derek Richards; Douglas  Hiscock; Sophia  Papadakis; Jamie Brown; Marcus Munafo; 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)  

Anna K. M. Blackwell, Shadi Daryan, Debbie Roy, Daniel Duffy, Garrett Hisler, Katherine Sawyer, Ben Ainsworth, Derek Richards, Douglas Hiscock, Sophia Papadakis, Jamie Brown, Marcus Munafo, Pamela Jacobsen, Paul Aveyard, Gemma Taylor

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	107541
Number of pages	9
Journal	Contemporary Clinical Trials
Volume	141
Early online date	26 Apr 2024
DOIs	https://doi.org/10.1016/j.cct.2024.107541
Publication status	Published - 30 Jun 2024

Data Availability Statement

At the end of the study, we will archive anonymised research data. Data will be uploaded to the University of Bath's Research Data Archive (https://researchdata.bath.ac.uk/). All data and data access will be restricted due to the sensitive nature of the data being collected (https://researchdata.bath.ac.uk/policies/). Data will be made available to approved bona-fide researchers, after they have signed a data access agreement, the person will be granted access to the University of Bath's Research Data Archive by the Research Data Services (https://data.blogs.ilrt.org/). Participants will consent to this process at the start of the study. Data stored in the Archive will have a Data Object identifier (DOI).

Acknowledgements

The authors would like to thank the people with lived experience of smoking and mental health, and IAPT practitioners who took part in workshops and think aloud interviews to support the development of the SilverCloud smoking cessation program. We would also like to thank the SilverCloud content, research and development teams who created the smoking cessation intervention within the SilverCloud platform and created the automated recruitment procedures within SilverCloud for this trial.

Funding

This trial is funded by Cancer Research UK (PPRCPJT\100023) and sponsored by the University of Bath ([email protected]). The funding body and sponsor has no role the design of the study or collection, analysis, and interpretation of data, or in writing this manuscript. PA is an NIHR senior investigator and is funded by the NIHR Oxford Health Biomedical Research Centre, the NIHR Oxford Biomedical Research Centre, and NIHR Oxford and Thames Valley Applied Research Collaboration.

Funders	Funder number
NIHR Oxford Biomedical Research Centre
National Institute for Health and Care Research Applied Research Collaboration Oxford and Thames Valley
National Institute for Health and Care Research
University of Bath
Cancer Research UK	PPRCPJT\100023
Cancer Research UK

Keywords

Anxiety
Depression
Digital intervention
Mental health
Smoking cessation
Tobacco

ASJC Scopus subject areas

Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.cct.2024.107541Licence: CC BY

Cite this

Blackwell, A. K. M., Daryan, S., Roy, D., Duffy, D., Hisler, G., Sawyer, K., Ainsworth, B., Richards, D., Hiscock, D., Papadakis, S., Brown, J., Munafo, M., Jacobsen, P., Aveyard, P., & Taylor, G. (2024). 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)  . Contemporary Clinical Trials, 141, Article 107541. https://doi.org/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)  . / Blackwell, Anna K. M.; Daryan, Shadi ; Roy, Debbie et al.
In: Contemporary Clinical Trials, Vol. 141, 107541, 30.06.2024.

Research output: Contribution to journal › Article › peer-review

Blackwell, AKM , Daryan, S , Roy, D, Duffy, D, Hisler, G, Sawyer, K, Ainsworth, B, Richards, D, Hiscock, D, Papadakis, S, Brown, J, Munafo, M, Jacobsen, P, Aveyard, P & Taylor, G 2024, '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)  ', Contemporary Clinical Trials, vol. 141, 107541. https://doi.org/10.1016/j.cct.2024.107541

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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.",

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AU - Sawyer, Katherine

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N2 - 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.

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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)

Abstract

Data Availability Statement

Acknowledgements

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Other files and links

Fingerprint

Silvercloud smoking cessation

Cite this

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)

Abstract

Data Availability Statement

Acknowledgements

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Other files and links

Fingerprint

Projects

Silvercloud smoking cessation

Cite this

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)  