Naughton F, Hope A, Siegele-Brown C, Grant K, Barton G, Notley C, Mascolo C, Coleman T, Shepstone L, Sutton S, Prevost AT, Crane D, Greaves F, High J.
An Automated, Online Feasibility Randomized Controlled Trial of a Just-in-time Adaptive Intervention for Smoking Cessation (Quit Sense).
Nicotine Tob Res. 2023 Apr 14:ntad032. doi: 10.1093/ntr/ntad032. Epub ahead of print. PMID: 37055073.

Introduction. Learned smoking cues from a smoker's environment are a major cause of lapse and relapse. Quit Sense, a theory-guided Just-In-Time Adaptive Intervention smartphone app, aims to help smokers learn about their situational smoking cues and provide in-the-moment support to help manage these when quitting.

Methods. A two-arm feasibility randomized controlled trial (N = 209) to estimate parameters to inform a definitive evaluation. Smoker's willing to make a quit attempt were recruited using online paid-for adverts and randomized to "usual care" (text message referral to NHS SmokeFree website) or "usual care" plus a text message invitation to install Quit Sense. Procedures, excluding manual follow-up for nonresponders, were automated. Follow-up at 6 weeks and 6 months included feasibility, intervention engagement, smoking-related, and economic outcomes. Abstinence was verified using cotinine assessment from posted saliva samples.

Results. Self-reported smoking outcome completion rates at 6 months were 77% (95% CI 71%, 82%), viable saliva sample return rate was 39% (95% CI 24%, 54%), and health economic data 70% (95% CI 64%, 77%). Among Quit Sense participants, 75% (95% CI 67%, 83%) installed the app and set a quit date and, of those, 51% engaged for more than one week. The 6-month biochemically verified sustained abstinence rate (anticipated primary outcome for definitive trial), was 11.5% (12/104) among Quit Sense participants and 2.9% (3/105) for usual care (adjusted odds ratio = 4.57, 95% CIs 1.23, 16.94). No evidence of between-group differences in hypothesized mechanisms of action was found.

Conclusions. Evaluation feasibility was demonstrated alongside evidence supporting the effectiveness potential of Quit Sense.