Study protocol for a randomised controlled trial of Allen Carr’s Easyway programme versus Lambeth and Southwark NHS service for smoking cessation.
Wood, KV, Albery, IP, Moss, AC, White, S and Frings, D (2017). Study protocol for a randomised controlled trial of Allen Carr’s Easyway programme versus Lambeth and Southwark NHS service for smoking cessation. BMJ Open.
|Authors||Wood, KV, Albery, IP, Moss, AC, White, S and Frings, D|
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 long-term. Recently NICE called for comparative studies to determine the short- 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 NHS. Methods and analysis: A two-arm, parallel-group, blinded, randomised controlled trial will be conducted with people who smoke tobacco cigarettes, aged 18 or over and are motivated to quit. Exclusion criteria comprise 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 blind to participant condition, and participants blind to the condition they are not assigned to. Logistic regression will be used to estimate the effectiveness of the treatment condition upon smoking cessation at six months. 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: ClinicalTrials.gov Identifier Number NCT02855255; ISRCTN registration number: ISRCTN23584477.
|Keywords||Smoking; RCT; Public Health; Cessation|
|Publisher||London South Bank University|
|Digital Object Identifier (DOI)||doi:10.1136/bmjopen-2017-016867|
|14 Dec 2017|
|Publication process dates|
|Deposited||26 Oct 2017|
|Accepted||02 Oct 2017|
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