Abstract
BackgroundTobacco use is responsible for the death of about 1 in 10 individuals worldwide. Mindfulness training has shown preliminary efficacy as a behavioral treatment for smoking cessation. Recent advances in mobile health suggest advantages to smartphone-based smoking cessation treatment including smartphone-based mindfulness training. This study evaluates the efficacy of a smartphone app-based mindfulness training program for improving smoking cessation rates at 6-months follow-up.Methods/DesignA two-group parallel-randomized clinical trial with allocation concealment will be conducted. Group assignment will be concealed from study researchers through to follow-up. The study will be conducted by smartphone and online. Daily smokers who are interested in quitting smoking and own a smartphone (n = 140) will be recruited through study advertisements posted online. After completion of a baseline survey, participants will be allocated randomly to the control or intervention group. Participants in both groups will receive a 22-day smartphone-based treatment program for smoking. Participants in the intervention group will receive mobile mindfulness training plus experience sampling. Participants in the control group will receive experience sampling-only. The primary outcome measure will be one-week point prevalence abstinence from smoking (at 6-months follow-up) assessed using carbon monoxide breath monitoring, which will be validated through smartphone-based video chat.DiscussionThis is the first intervention study to evaluate smartphone-based delivery of mindfulness training for smoking cessation. Such an intervention may provide treatment in-hand, in real-world contexts, to help individuals quit smoking.Trial registrationClinicaltrials.gov NCT02134509. Registered 7 May 2014.
Highlights
Tobacco use is responsible for the death of about 1 in 10 individuals worldwide
These approaches have only modest success, with 6–12 month abstinence rates of 20-30% [5,6]. Their limited success may be due to the fact that smoking triggers are always present, making avoidance difficult; diversion of attention requires cognitive resources which are often depleted after strong affective states [7]; and effective substitutions are not always readily available
Many meditation-related smartphone apps are available, very few have been tested for use in clinical groups such as smokers [18]
Summary
This trial is the first to test smartphone app-based mindfulness training to for smoking cessation. In-person mindfulness training has been found to improve smoking cessation rates and decrease the association between craving and smoking [14]. This trial will test whether mobile mindfulness training is associated with similar outcomes. Alternative comparators could be in-person mindfulness training, an online smoking cessation program, waitlist control, or another smartphone-based smoking cessation intervention. If the intervention is found to be effective, this RCT will provide a platform for large-scale clinical trials to compare mobile mindfulness training to active behavioral treatments for smoking cessation, and to disseminate this treatment to the wider community. All other authors declare that they have no competing interests.
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