Randomised controlled trial of a Just-In-Time Adaptive Intervention (JITAI) smoking cessation smartphone app: The Quit Sense feasibility trial protocol

Naughton, Felix; Brown, Chlo�; High, Juliet; Notley, Caitlin; Mascolo, Cecilia; Coleman, Tim; Barton, Garry; Shepstone, Lee; Sutton, Stephen; Prevost, Toby; Crane, David; Greaves, Felix; Hope, Aimie

Abstract

Introduction A lapse (any smoking) early in a smoking cessation attempt is strongly associated with reduced success. A substantial proportion of lapses are due to urges to smoke triggered by situational cues. Currently no available interventions proactively respond to such cues in real time. Quit Sense is a theory-guided Just-In-Time Adaptive Intervention (JITAI) smartphone app that uses a learning tool and smartphone sensing to provide in-the-moment tailored support to help smokers manage cue-induced urges to smoke. The primary aim of this randomised controlled trial (RCT) is to assess the feasibility of delivering a definitive online efficacy trial of Quit Sense.

Methods and analyses A two arm parallel-group RCT allocating smokers willing to make a quit attempt, recruited via online adverts,to usual care (referral to the NHS SmokeFree website) or usual care plus Quit Sense. Randomisation will be stratified by smoking rate (≤16 vs. ≥ 16 cigarettes/day) and socioeconomic status (low vs. high). Recruitment, enrolment, baseline data collection, allocation and intervention delivery will be automated through the study website. Outcomes will be collected at 6 weeks and 6 months follow-up via the study website or telephone, and during app usage. The study aims to recruit 200 smokers to estimate key feasibility outcomes, the preliminary impact of Quit Sense, and potential cost-effectiveness, in addition to gaining insights on user views of the app through qualitative interviews.

Citation

Naughton, F., Brown, C., High, J., Notley, C., Mascolo, C., Coleman, T., …Hope, A. (2021). Randomised controlled trial of a Just-In-Time Adaptive Intervention (JITAI) smoking cessation smartphone app: The Quit Sense feasibility trial protocol. BMJ Open, 11, Article e048204. https://doi.org/10.1136/bmjopen-2020-048204

• Journal Article Type: Article
• Acceptance Date: Mar 12, 2021
• Online Publication Date: Apr 26, 2021
• Publication Date: Apr 26, 2021
• Deposit Date: Mar 12, 2021
• Publicly Available Date: Apr 26, 2021
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 11
• Article Number: e048204
• DOI: https://doi.org/10.1136/bmjopen-2020-048204
• Keywords: Smoking cessation, smartphone app, sensing, trial, online, just-in-time adaptive intervention
• Public URL: https://nottingham-repository.worktribe.com/output/5388446
• Publisher URL: https://bmjopen.bmj.com/content/11/4/e048204