Randomised controlled trial of a just-in-time adaptive intervention (JITAI) smoking cessation smartphone app: the Quit Sense feasibility trial protocol

Abstract

IntroductionA 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 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 analysesA 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.Ethics and disseminationEthics approval has been granted by the Wales NHS Research Ethics Committee 7 (19/WA/0361). The findings will be disseminated to the public, the funders, relevant practice and policy representatives and other researchers.Trial registration numberISRCTN12326962.

Opportunities for Smartphone Sensing in E-Health Research: A Narrative Review

“…A further six studies examined the use of smartphone sensing to detect intake and intoxication due to substances such as alcohol [ 60 , 61 , 62 ], tobacco [ 63 ], and cannabis [ 12 , 64 ]. They utilized location and activity data to understand the contexts of consumption and its impact on mobility.…”

“…For example, cannabis intake would impact gait and reduce physical activity, which can be monitored through accelerometer [ 64 ] and location data [ 12 ]. This ability to detect intake instances was seen to provide useful opportunities for intervention using smartphones [ 63 ].…”

Acu.ation: Real Time Acupoint Stimulation To Mediate The Urge To Smoke.

“…Similarly, Costa et al have shown promising results for a wearable smartwatch to regulate emotions in the moment using vibrations that mimic one's heart rate [12]. In the context of smoking cessation, multiple studies are exploring ways to deliver CBT or mindfulness strategies in the moment when a person experiences a trigger or urge to smoke [9,11,20,24]. However, to our knowledge, no interventions have combined cognitive behavioral strategies with haptic methods of decreasing arousal in the moment of cuereactivity.…”

A digital solution to streamline access to smoking cessation interventions in England; findings from a primary care pilot (STOPNOW study)

“…A systematic review of trials that compared a tailored and interactive Internet intervention to a non-active control demonstrated an effect in favour of the intervention [ 16 ], but none of these studies involved making a formal request for treatment using an online portal with direct linkage to general practice. There is already widespread availability of smartphone applications [ [20] , [21] , [22] , [23] ] and online support tools for smoking cessation [ 24 ] with demonstrable evidence of effectiveness of internet based interventions [ 16 , 25 ].…”