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Study protocol for a randomised controlled trial of Allen Carr’s Easyway programme versus Lambeth and Southwark NHS for smoking cessation
  1. Kerry V Wood1,
  2. Ian P Albery1,
  3. Antony C Moss1,
  4. Sarah White2,
  5. Daniel Frings1
  1. 1 Division of Psychology, London South Bank University, London, UK
  2. 2 Population Health Research Institute, St Georges University of London, London, UK
  1. Correspondence to Dr Kerry V Wood; woodk6{at}lsbu.ac.uk

Abstract

Introduction Smoking is a major cause of ill health and is associated with several diseases including cancer, coronary heart disease and stroke. Many psychological and pharmacological smoking cessation treatments are available and although they are undoubtedly the most cost-effective health interventions available, many people still fail to maintain cessation in the longer term. Recently, National Institute for Health and Care Excellence called for comparative studies to determine the short-term and long-term effectiveness of Allen Carr’s Easyway (ACE) method of stopping smoking. This study will compare the efficacy of the ACE programme and a 1–1 counselling service available via the National Health Service.

Methods and analysis A two-arm, parallel-group, blinded, randomised controlled trial will be conducted with people who smoke tobacco cigarettes, are aged ≥18 years and are motivated to quit. Exclusion criteria comprise self-reported mental health condition, pregnancy or respiratory disease such as chronic obstructive pulmonary disease or emphysema. The primary treatment outcome is smoking cessation 26 weeks after treatment. Participants will be analysed on an intention to treat basis at the point of randomisation. Before being randomised, the research team will not inform participants which two treatments are being compared. Once randomised researchers will be blinded to participant condition, and participants will be blinded to the condition they are not assigned to. Logistic regression will be used to estimate the effectiveness of the treatment condition on smoking cessation at 26 weeks. The following covariates will be included: baseline quit efficacy (at inclusion), age (at inclusion), gender and baseline nicotine dependency.

Ethics and dissemination Approval was granted by London–Fulham Research Ethics Committee (ref: 16/LO/1657). The study’s findings will be published in peer-reviewed journals and disseminated at national and international conferences.

Trial registration number ClinicalTrials.gov identifier number: NCT02855255. ISRCTN registration number: ISRCTN23584477; Pre-results.

  • public health
  • smoking
  • randomised controlled trial

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors DF, IPA and ACM conceived the design of the trial and secured funding. DF wrote the study protocol. KVW manages the day to day running of the trial; wrote protocol paper with input from all coauthors. SW data analyses. DF is guarantor for this paper. All authors: read and approved the final manuscript.

  • Funding This trial is funded in full by Allen Carr’s Easyway (International) Ltd.

  • Disclaimer The NHS smoking cessation intervention is provided by Lambeth Stop Smoking Service. The design, conduct,data collection, analyses and interpretation of the trial are conducted by LSBU, independent from Allen Carr’s Easy way (International) Ltd. Based on the findings, papers for publication will be prepared by the research team at LSBU who will have ultimate authority over these activities. The research team are contractually free to publish whatever findings the study produces, ACE has no veto over publication, but will be given advanced notice of the findings prior to publication.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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