Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jan 22:5:16.
doi: 10.1186/s40814-018-0385-2. eCollection 2019.

IntEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety (ESCAPE): protocol for a randomised and controlled, multicentre, acceptability, feasibility and implementation trial

Gemma Taylor  1 , Paul Aveyard  2 , Kate Bartlem  3   4 , Alison Shaw  5 , Jeremy Player  6 , Chris Metcalfe  7 , David Kessler  8 , Marcus Munafò  9   10
Affiliations

IntEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety (ESCAPE): protocol for a randomised and controlled, multicentre, acceptability, feasibility and implementation trial

Gemma Taylor et al. Pilot Feasibility Stud. .

Abstract

Background: People with depression/anxiety are twice as likely to smoke and are less responsive to standard tobacco treatments, leading to a reduced life expectancy of up to 13.6 years compared to people without depression/anxiety. However, this group of smokers is motivated to quit, and as a result of quitting smoking, their depression/anxiety is likely to improve. In England, people with depression/anxiety are referred to a primary care-based psychological therapies service known as 'Improving Access to Psychological Therapies' (IAPT), which could offer smoking cessation treatment as part of usual care but currently does not. In this study, we aim (1) to establish the feasibility and acceptability of delivering a smoking cessation treatment alongside IAPT usual care and (2) to establish the feasibility of a multi-centre randomised trial to compare the combined smoking cessation and IAPT treatment to usual IAPT treatment alone.

Methods: A randomised and controlled, multi-centre trial to test the acceptability, feasibility and implementation of smoking cessation treatment as offered alongside usual IAPT care, compared to usual care alone, with nested qualitative methods. We will include adult daily smokers with depression/anxiety, who would like help to quit smoking and are about to start IAPT treatment. Follow-up will be conducted at 3-months after baseline. The main outcome will be retention in the smoking cessation treatment. Secondary outcomes are smoking-related (biochemically-verified 7-day point prevalence smoking cessation, number of cigarettes smoked per day, Heaviness of Smoking Index), mental health-related (PHQ-9), service-related (number of 'Did Not Attends', number of planned and completed IAPT sessions), acceptability and feasibility (participant and clinician acceptability and satisfaction of intervention as assessed by questionnaires and qualitative interviews, interviews will also explore acceptability and feasibility of data collection procedures and impact of smoking cessation treatment on usual care and mental health recovery) and implementation-related (intervention delivery checklist, qualitative analysis of intervention delivery).

Discussion: If the intervention is shown to be acceptable, feasible and suitably implemented, we can conduct a randomised controlled trial. In a future trial, we would examine whether adding smoking cessation treatment increases smoking abstinence and improves depression and anxiety more than usual care, which would lead to long-term health improvement.

Trial registration: ISRCTN99531779.

PubMed Disclaimer

Conflict of interest statement

Gemma Taylor is an Assistant Professor in Clinical Psychology and the University of Bath, United Kingdom; Paul Aveyard is a Professor of Behavioural Medicine at the University of Oxford; Kate Bartlem is a Research Fellow at, the University of Newcastle, Australia; Ali Shaw is a Senior Research Fellow at the University of Bristol; Jeremy Player is a Project Support Officer at Solutions4Health; Chris Metcalfe is a Professor of Medical Statistics at the University of Bristol; David Kessler is a Reader in Primary Care at the University of Bristol; Marcus Munafò is a Professor of Biological Psychology at the University of Bristol.This study received ethics approval from the National Health Service Research Ethics Committee on 19/03/2018 (IRAS ID: 239339). Contact details for sponsor: Dr Lisa Austin, University of Bath, Bath, United Kingdom, l.austin@bath.ac.uk.Not applicable.Drs. Ali Shaw, David Kessler and Kate Bartlem have no conflicts of interest. Professor Chris Metcalfe has no conflicts of interest. Dr Gemma Taylor and Professor Marcus Munafò have received funding from Pfizer, who manufacture smoking cessation products. Professor Paul Aveyard led a trial funded by the NIHR and Glaxo Smith Kline donated nicotine patches to the NHS in support of the trial.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of study events
See this image and copyright information in PMC

References

    1. World Health Organisation. WHO report on the global tobacco epidemic: warning about the dangers of tobacco. Geneva, Switzerland. 2011.
    1. Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years observations on male British doctors. BMJ. 2004;328:1519. doi: 10.1136/bmj.38142.554479.AE. - DOI - PMC - PubMed
    1. Pirie K, Peto R, Reeves G, Green J, Beral V. The 21st century hazards of smoking and benefits of stopping: a prospective study of one million women in the UK. Lancet. 2013;381:133–141. doi: 10.1016/S0140-6736(12)61720-6. - DOI - PMC - PubMed
    1. Eriksen M, Mackay J, Ross H. The Tobacco Atlas. Atlanta: The World Lung Foundation & The American Cancer Society; 2012.
    1. Office for National Statistics. General lifestyle survey: chapter 1. smoking. London, UK. 2014.