Preventing smoking relapse, managing cue-induced cravings Other
Conditions
Interventions
The researchers have developed a theory-guided Just-In-Time Adaptive Intervention (JITAI) smartphone app (Quit Sense), which provides smokers with in-the-moment support to help manage cue-induced crav
Sponsors
University of East Anglia
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Current smokers (at least 7 cigarettes per week) 2. Willing to make a quit attempt in the next 14 days 3. Has primary use of an Android smartphone (version 5.0 and above) 4. Age 16 years and above 5. Resident in England 6. Able and willing to provide informed consent using the web-based form
Exclusion criteria
Exclusion criteria: 1. Not previously participated in this trial 2. At present the app and related study materials are in English and so potential participants would require an understanding of basic written English in order to give informed consent and engage with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As this is a feasibility trial there is no primary outcome. Outcomes will be collected to enable an estimation of key parameters to inform a future trial, in line with MRC guidance, and to provide preliminary information about the impact of the intervention: 1. Completeness of the anticipated primary outcome for a future definitive trial (self-reported abstinence with biochemical validation at 6.5 months post enrolment) 2. Cost per recruit, based on recruitment advertising costs gathered by the online recruitment company (Nativve) during the trial recruitment phase (February-March 2020) 3. Rates of app installation, use and support delivery fidelity measured using initialisation data recorded by the Quit Sense app during the period of participant engagement with the app (for approximately 3 months post enrolment in study) 4. Completion of smoking cessation-related resource use and quality of life (EQ-5D-5L) data at enrolment and in the 6.5-month online follow-up survey | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Abstinence rate of usual care arm, using the anticipated primary outcome for a future definitive trial: self-reported abstinence in the previous 6 months allowing for no more than five cigarettes and not smoking in the previous week measured at the 6.5 month follow up, biochemically validated among those reporting abstinence by a saliva cotinine or anabasine collected by post 2. Hypothesised mechanisms of action of Quit Sense: 2.1. Lapse incidence (any smoking, even a puff), which is highly predictive of relapse 2.2. Lapse prevention strategy use, which is associated with lapse prevention 2.3. Self-efficacy, which prospectively predicts lapse and relapse to smoking 2.4. The Strength of Urges to Smoke (SUTS) measure, which prospectively predicts abstinence and is superior to other urge measures in doing so 2.5. Automaticity and associative processes subscales from the Wisconsin Inventory of Smoking Dependence Motives (WISDM-37), which is a validated measure with good psychometric properties This data will be collected 6 weeks after participants enrolment in the trial | — |
Countries
England, United Kingdom
Outcome results
None listed