title: A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol.
abstract: BACKGROUND
  Tobacco 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
  A 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT02134509 . Registered 7 May 2014.
authors.affiliation: Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA. kathleen.garrison@yale.edu.|, 1 Church Street, Room 730, New Haven, CT 06510, USA. kathleen.garrison@yale.edu.
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Garrison
authors.affiliation: Departments of Medicine and Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA. prasanta.pal@umassmed.edu.
authors.forename: Prasanta
authors.initials: P
authors.lastname: Pal
authors.affiliation: Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA. rarojiani@gmail.com.|Departments of Medicine and Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA. rarojiani@gmail.com.
authors.forename: Rahil
authors.initials: R
authors.lastname: Rojiani
authors.affiliation: Department of Psychology, University of Florida, Gainesville, FL, USA. dallery@ufl.edu.
authors.forename: Jesse
authors.initials: J
authors.lastname: Dallery
authors.affiliation: Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA. stephanie.omalley@yale.edu.
authors.forename: Stephanie S
authors.initials: SS
authors.lastname: O'Malley
authors.affiliation: Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA. judson.brewer@umassmed.edu.|Departments of Medicine and Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA. judson.brewer@umassmed.edu.
authors.forename: Judson A
authors.initials: JA
authors.lastname: Brewer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001521:Behavior Therapy / Q000379:methods; D040421:Cell Phone; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D064866:Mindfulness / Q000379:methods*; D012107:Research Design; D012907:Smoking / Q000628:therapy*; D016540:Smoking Cessation / Q000379:methods*; D017216:Telemedicine / Q000379:methods*; D055815:Young Adult