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Randomized Controlled Trial
A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol.
- Kathleen A Garrison, Prasanta Pal, Rahil Rojiani, Jesse Dallery, Stephanie S O'Malley, and Judson A Brewer.
- Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA. kathleen.garrison@yale.edu.
- Bmc Psychiatry. 2015 Apr 14; 15: 83.
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.
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