Integrating Smoking Cessation Treatment Into Web-Based Usual Psychological Care for People With Common Mental Illness: Feasibility Randomized Controlled Trial (ESCAPE Digital)

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

doi:10.2196/78424

Integrating Smoking Cessation Treatment Into Web-Based Usual Psychological Care for People With Common Mental Illness: Feasibility Randomized Controlled Trial (ESCAPE Digital)

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

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

Abstract

BACKGROUND: Stopping smoking can improve mental health, with effect sizes similar to antidepressant treatment. Internet-based cognitive behavioral therapy (iCBT) provides evidence-based treatment for depression and anxiety, and digital interventions can support smoking cessation. However, combined digital smoking and mental health support is not currently available in UK health services.

OBJECTIVE: This feasibility trial aimed to investigate the acceptability and feasibility of a digital tailored smoking cessation intervention delivered alongside usual iCBT, and test trial procedures.

METHODS: The study design was a 2-armed, parallel groups, pragmatic, feasibility randomized controlled trial. Eligible participants were adult (18 years and older), regular smokers referred to iCBT from National Health Service Talking Therapies services in England. Participants were screened, consented, and randomized via a web-based platform and allocated to intervention (integrated smoking cessation support) or control (usual care) arms. Fully automated processes ensured allocation concealment. It was not possible to blind participants or clinicians to the behavioral intervention. Follow-ups via web-based questionnaires were completed at 3- and 6-months. Prespecified progression criteria, to determine the feasibility of the integrated intervention and trial procedures for a definitive trial, were enrolment of eligible clients (≥20%); recruitment to the target (≥80%); outcome data completeness (≥70%); and self-reported quit attempts in the intervention arm (≥8%).

RESULTS: A total of 309 participants were randomized: 154 to the intervention arm and 155 to the control arm. The proportion of eligible clients enrolled (309/1484, 21%) met the criteria for progression; however, the number randomized was below target (309/500, 62%). In the intervention arm, 18% (27/154) self-reported at least one quit attempt, which exceeded the progression criteria but was comparable to the control arm (32/155, 21%). High loss to follow-up meant data completeness was low (<30% across 6 key pilot clinical outcomes).

CONCLUSIONS: Integrating smoking cessation within digital mental health treatment and using automated procedures to enroll and randomize participants appears feasible. Adjustments to site recruitment could improve participant recruitment; however, a large loss to follow-up undermines the feasibility of progression.

TRIAL REGISTRATION: ISRCTN Registry ISRCTN10612149; https://www.isrctn.com/ISRCTN10612149.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.cct.2024.107541.

Original language	English
Article number	e78424
Journal	JMIR mental health
Volume	12
Early online date	5 Dec 2025
DOIs	https://doi.org/10.2196/78424
Publication status	Published - 5 Dec 2025

Data Availability Statement

The study protocol and statistical analysis plan are available from the ISRCTN Registry. The datasets generated or analyzed during this study (deidentified participant data and data dictionary) are available from the University of Bath’s Research Data Archive [36]. Data access is restricted and will be made available to approved bona fide researchers after they have signed a data access agreement with the Research Data Services. Participants consented to the sharing of anonymized data at the start of the study.

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 had no role in the design of the study or collection, analysis, and interpretation of data, or in writing this manuscript. PA was funded by National Institute for Health and Care Research (NIHR) Oxford and Thames Valley Applied Research Collaboration, NIHR Oxford Health Biomedical Research Centre, and NIHR Oxford Biomedical Research Centre. AB, SD, DR, PJ, BA, PA, KS, and MM declare no competing interests. GT previously received funding from Pfizer, who manufacture smoking cessation products, for research unrelated to this study. GT previously worked at a scientific consultancy providing statistical and research support for pharmaceutical companies to medicines unrelated to this manuscript. JB has received (most recently awarded in 2018) unrestricted research funding via his university to study smoking from Pfizer and J&J, which manufacture smoking cessation medications. JB is an unpaid member of the scientific steering group of the Smoke Free mobile app. DH, DD, and GH are employees and shareholders of Amwell, a company of which SilverCloud Health is a subsidiary. SP has received unrestricted research funding via her university to study smoking from Global Bridges in partnership with Pfizer, who manufacture smoking cessation medications.

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

UN SDGs

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

SDG 3 Good Health and Well-being

Keywords

Humans
Smoking Cessation/methods
Feasibility Studies
Male
Adult
Female
Cognitive Behavioral Therapy/methods
Middle Aged
Mental Disorders/therapy
Internet-Based Intervention
England
Internet

ASJC Scopus subject areas

Psychiatry and Mental health

Access to Document

10.2196/78424Licence: CC BY

Cite this

Taylor, G., Jacobsen, P., Blackwell, A., Daryan, S., Roy, D., Duffy, D., Hisler, G., Sawyer, K., Ainsworth, B., Hiscock, D., Papadakis, S., Brown, J., Munafo, M., & Aveyard, P. (2025). Integrating Smoking Cessation Treatment Into Web-Based Usual Psychological Care for People With Common Mental Illness: Feasibility Randomized Controlled Trial (ESCAPE Digital). JMIR mental health, 12, Article e78424. https://doi.org/10.2196/78424

Taylor, G , Jacobsen, P, Blackwell, A, Daryan, S, Roy, D, Duffy, D, Hisler, G, Sawyer, K, Ainsworth, B, Hiscock, D, Papadakis, S, Brown, J, Munafo, M & Aveyard, P 2025, 'Integrating Smoking Cessation Treatment Into Web-Based Usual Psychological Care for People With Common Mental Illness: Feasibility Randomized Controlled Trial (ESCAPE Digital)', JMIR mental health, vol. 12, e78424. https://doi.org/10.2196/78424

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title = "Integrating Smoking Cessation Treatment Into Web-Based Usual Psychological Care for People With Common Mental Illness: Feasibility Randomized Controlled Trial (ESCAPE Digital)",

abstract = "BACKGROUND: Stopping smoking can improve mental health, with effect sizes similar to antidepressant treatment. Internet-based cognitive behavioral therapy (iCBT) provides evidence-based treatment for depression and anxiety, and digital interventions can support smoking cessation. However, combined digital smoking and mental health support is not currently available in UK health services.OBJECTIVE: This feasibility trial aimed to investigate the acceptability and feasibility of a digital tailored smoking cessation intervention delivered alongside usual iCBT, and test trial procedures.METHODS: The study design was a 2-armed, parallel groups, pragmatic, feasibility randomized controlled trial. Eligible participants were adult (18 years and older), regular smokers referred to iCBT from National Health Service Talking Therapies services in England. Participants were screened, consented, and randomized via a web-based platform and allocated to intervention (integrated smoking cessation support) or control (usual care) arms. Fully automated processes ensured allocation concealment. It was not possible to blind participants or clinicians to the behavioral intervention. Follow-ups via web-based questionnaires were completed at 3- and 6-months. Prespecified progression criteria, to determine the feasibility of the integrated intervention and trial procedures for a definitive trial, were enrolment of eligible clients (≥20\%); recruitment to the target (≥80\%); outcome data completeness (≥70\%); and self-reported quit attempts in the intervention arm (≥8\%).RESULTS: A total of 309 participants were randomized: 154 to the intervention arm and 155 to the control arm. The proportion of eligible clients enrolled (309/1484, 21\%) met the criteria for progression; however, the number randomized was below target (309/500, 62\%). In the intervention arm, 18\% (27/154) self-reported at least one quit attempt, which exceeded the progression criteria but was comparable to the control arm (32/155, 21\%). High loss to follow-up meant data completeness was low (<30\% across 6 key pilot clinical outcomes).CONCLUSIONS: Integrating smoking cessation within digital mental health treatment and using automated procedures to enroll and randomize participants appears feasible. Adjustments to site recruitment could improve participant recruitment; however, a large loss to follow-up undermines the feasibility of progression.TRIAL REGISTRATION: ISRCTN Registry ISRCTN10612149; https://www.isrctn.com/ISRCTN10612149.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.cct.2024.107541.",

keywords = "Humans, Smoking Cessation/methods, Feasibility Studies, Male, Adult, Female, Cognitive Behavioral Therapy/methods, Middle Aged, Mental Disorders/therapy, Internet-Based Intervention, England, Internet",

author = "Gemma Taylor and Pamela Jacobsen and Anna Blackwell and Shadi Daryan and Debbie Roy and Daniel Duffy and Garrett Hisler and Katherine Sawyer and Ben Ainsworth and Douglas Hiscock and Sophia Papadakis and Jamie Brown and Marcus Munafo and Paul Aveyard",

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T1 - Integrating Smoking Cessation Treatment Into Web-Based Usual Psychological Care for People With Common Mental Illness

T2 - Feasibility Randomized Controlled Trial (ESCAPE Digital)

AU - Taylor, Gemma

AU - Jacobsen, Pamela

AU - Blackwell, Anna

AU - Daryan, Shadi

AU - Roy, Debbie

AU - Duffy, Daniel

AU - Hisler, Garrett

AU - Sawyer, Katherine

AU - Ainsworth, Ben

AU - Hiscock, Douglas

AU - Papadakis, Sophia

AU - Brown, Jamie

AU - Munafo, Marcus

AU - Aveyard, Paul

PY - 2025/12/5

Y1 - 2025/12/5

N2 - BACKGROUND: Stopping smoking can improve mental health, with effect sizes similar to antidepressant treatment. Internet-based cognitive behavioral therapy (iCBT) provides evidence-based treatment for depression and anxiety, and digital interventions can support smoking cessation. However, combined digital smoking and mental health support is not currently available in UK health services.OBJECTIVE: This feasibility trial aimed to investigate the acceptability and feasibility of a digital tailored smoking cessation intervention delivered alongside usual iCBT, and test trial procedures.METHODS: The study design was a 2-armed, parallel groups, pragmatic, feasibility randomized controlled trial. Eligible participants were adult (18 years and older), regular smokers referred to iCBT from National Health Service Talking Therapies services in England. Participants were screened, consented, and randomized via a web-based platform and allocated to intervention (integrated smoking cessation support) or control (usual care) arms. Fully automated processes ensured allocation concealment. It was not possible to blind participants or clinicians to the behavioral intervention. Follow-ups via web-based questionnaires were completed at 3- and 6-months. Prespecified progression criteria, to determine the feasibility of the integrated intervention and trial procedures for a definitive trial, were enrolment of eligible clients (≥20%); recruitment to the target (≥80%); outcome data completeness (≥70%); and self-reported quit attempts in the intervention arm (≥8%).RESULTS: A total of 309 participants were randomized: 154 to the intervention arm and 155 to the control arm. The proportion of eligible clients enrolled (309/1484, 21%) met the criteria for progression; however, the number randomized was below target (309/500, 62%). In the intervention arm, 18% (27/154) self-reported at least one quit attempt, which exceeded the progression criteria but was comparable to the control arm (32/155, 21%). High loss to follow-up meant data completeness was low (<30% across 6 key pilot clinical outcomes).CONCLUSIONS: Integrating smoking cessation within digital mental health treatment and using automated procedures to enroll and randomize participants appears feasible. Adjustments to site recruitment could improve participant recruitment; however, a large loss to follow-up undermines the feasibility of progression.TRIAL REGISTRATION: ISRCTN Registry ISRCTN10612149; https://www.isrctn.com/ISRCTN10612149.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.cct.2024.107541.

AB - BACKGROUND: Stopping smoking can improve mental health, with effect sizes similar to antidepressant treatment. Internet-based cognitive behavioral therapy (iCBT) provides evidence-based treatment for depression and anxiety, and digital interventions can support smoking cessation. However, combined digital smoking and mental health support is not currently available in UK health services.OBJECTIVE: This feasibility trial aimed to investigate the acceptability and feasibility of a digital tailored smoking cessation intervention delivered alongside usual iCBT, and test trial procedures.METHODS: The study design was a 2-armed, parallel groups, pragmatic, feasibility randomized controlled trial. Eligible participants were adult (18 years and older), regular smokers referred to iCBT from National Health Service Talking Therapies services in England. Participants were screened, consented, and randomized via a web-based platform and allocated to intervention (integrated smoking cessation support) or control (usual care) arms. Fully automated processes ensured allocation concealment. It was not possible to blind participants or clinicians to the behavioral intervention. Follow-ups via web-based questionnaires were completed at 3- and 6-months. Prespecified progression criteria, to determine the feasibility of the integrated intervention and trial procedures for a definitive trial, were enrolment of eligible clients (≥20%); recruitment to the target (≥80%); outcome data completeness (≥70%); and self-reported quit attempts in the intervention arm (≥8%).RESULTS: A total of 309 participants were randomized: 154 to the intervention arm and 155 to the control arm. The proportion of eligible clients enrolled (309/1484, 21%) met the criteria for progression; however, the number randomized was below target (309/500, 62%). In the intervention arm, 18% (27/154) self-reported at least one quit attempt, which exceeded the progression criteria but was comparable to the control arm (32/155, 21%). High loss to follow-up meant data completeness was low (<30% across 6 key pilot clinical outcomes).CONCLUSIONS: Integrating smoking cessation within digital mental health treatment and using automated procedures to enroll and randomize participants appears feasible. Adjustments to site recruitment could improve participant recruitment; however, a large loss to follow-up undermines the feasibility of progression.TRIAL REGISTRATION: ISRCTN Registry ISRCTN10612149; https://www.isrctn.com/ISRCTN10612149.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.cct.2024.107541.

KW - Humans

KW - Smoking Cessation/methods

KW - Feasibility Studies

KW - Male

KW - Adult

KW - Female

KW - Cognitive Behavioral Therapy/methods

KW - Middle Aged

KW - Mental Disorders/therapy

KW - Internet-Based Intervention

KW - England

KW - Internet

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U2 - 10.2196/78424

DO - 10.2196/78424

M3 - Article

C2 - 41348446

SN - 2368-7959

VL - 12

JO - JMIR mental health

JF - JMIR mental health

M1 - e78424

ER -

Integrating Smoking Cessation Treatment Into Web-Based Usual Psychological Care for People With Common Mental Illness: Feasibility Randomized Controlled Trial (ESCAPE Digital)

Abstract

Data Availability Statement

Funding

UN SDGs

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Silvercloud smoking cessation

Dataset for Integrating Online Stop Smoking Support with Online Talking Therapies

Cite this

Integrating Smoking Cessation Treatment Into Web-Based Usual Psychological Care for People With Common Mental Illness: Feasibility Randomized Controlled Trial (ESCAPE Digital)

Abstract

Data Availability Statement

Funding

UN SDGs

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Projects

Silvercloud smoking cessation

Datasets

Dataset for Integrating Online Stop Smoking Support with Online Talking Therapies

Cite this