title: Testing the efficacy of yoga as a complementary therapy for smoking cessation: design and methods of the BreathEasy trial.
abstract: BACKGROUND
  Smokers trying to quit encounter many challenges including nicotine withdrawal symptoms, cigarette craving, increased stress and negative mood and concern regarding weight gain. These phenomena make it difficult to successfully quit smoking. Studies in non-smoking populations show that yoga reduces stress and negative mood and improves weight control. By increasing mindfulness we anticipate that yoga may also improve smokers' ability to cope with the negative symptoms associated with quitting. Yoga may also improve cognitive deliberation which is needed to make effective choices and avoid smoking in tempting situations.
  
  
  METHODS
  The BreathEasy study is a rigorous, randomized controlled clinical trial examining the efficacy of Iyengar yoga as a complementary therapy to cognitive-behavioral therapy for smoking cessation. All participants are given an 8-week program of smoking cessation classes, and are randomized to either twice weekly yoga (Yoga) or twice-weekly health and wellness classes which serve as a control for contact and participant burden (CTL). Assessments are conducted at baseline, 8 weeks, 3, 6, and 12 months of follow-up. The primary outcome is prolonged abstinence using an intention-to-treat approach. Multiple internal and external audits using blind data collection are employed to ensure treatment fidelity and reliability of study results. To understand why yoga may be more effective than CTL, we will examine the mechanisms of action (i.e., mediators) underlying intervention efficacy. We will examine the maintenance of yoga practice and smoking status at each follow-up. Focus groups and interviews will be used to enrich our understanding of the relationship of yoga practice and smoking abstinence.
  
  
  CONCLUSIONS
  This study will provide a stringent test of the relative efficacy of yoga compared to a condition that controls for contact time and attention. The use of mixed methodology also provides the opportunity to validate existing knowledge about yoga and helps to explore new themes for future mindfulness and yoga research.
authors.affiliation: Alpert Medical School of Brown University, The Miriam Hospital, 167 Point Street, Providence, RI 02903, USA. Electronic address: Bbock@Lifespan.org.
authors.forename: Beth C
authors.initials: BC
authors.lastname: Bock
authors.affiliation: Center for Behavioral and Preventive Medicine, The Miriam Hospital, Department of Behavioral and Social Sciences, School of Public Health, Brown University, 167 Point Street, Providence, RI 02903, USA. Electronic address: Rrosen@lifespan.org.
authors.forename: Rochelle K
authors.initials: RK
authors.lastname: Rosen
authors.affiliation: Centers for Behavioral and Preventive Medicine, The Miriam Hospital, 167 Point Street, Providence, RI 02903, USA. Electronic address: jfava@lifespan.org.
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Fava
authors.affiliation: University of Massachusetts Medical School, School of Public Health, Brown University, 55 Lake Avenue N., Worcester, MA 01655, USA. Electronic address: Ronnesia_gaskins@brown.edu.
authors.forename: Ronnesia B
authors.initials: RB
authors.lastname: Gaskins
authors.affiliation: Center for Behavioral and Preventive Medicine, The Miriam Hospital, Alpert Medical School of Brown University, 167 Point Street, Providence, RI 02903, USA. Electronic address: Ejennings1@lifespan.org.
authors.forename: Ernestine
authors.initials: E
authors.lastname: Jennings
authors.affiliation: Center for Behavioral and Preventive Medicine, The Miriam Hospital, Alpert Medical School of Brown University, 167 Point Street, Providence, RI 02903, USA. Electronic address: Hthind@Lifespan.org.
authors.forename: Herpreet
authors.initials: H
authors.lastname: Thind
authors.affiliation: University of Massachusetts Medical School, 55N. Lake Avenue, Worcester, MA 01655, USA. Electronic address: James.carmody@umassmed.edu.
authors.forename: James
authors.initials: J
authors.lastname: Carmody
authors.affiliation: Center for Behavioral and Preventive Medicine, The Miriam Hospital, Department of Behavioral and Social Sciences, School of Public Health, Brown University, 167 Point Street, Providence, RI 02903, USA. Electronic address: sdunsiger@lifespan.org.
authors.forename: Shira I
authors.initials: SI
authors.lastname: Dunsiger
authors.affiliation: The Motion Center, 111 Chestnut Street, Providence, RI 02903, USA. Electronic address: naama@motioncenter.com.
authors.forename: Naama
authors.initials: N
authors.lastname: Gidron
authors.affiliation: Alpert Medical School of Brown University, Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903, USA. Electronic address: Bbecker@Lifespan.org.
authors.forename: Bruce M
authors.initials: BM
authors.lastname: Becker
authors.affiliation: Department of Family and Preventive Medicine, University of California, San Diego, 9500 Gilman Dr, La Jolla, CA 92093, USA. Electronic address: Bmarcus@ucsd.edu.
authors.forename: Bess H
authors.initials: BH
authors.lastname: Marcus
mesh_terms: D000367:Age Factors; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D005260:Female; D015438:Health Behavior; D006304:Health Status; D006801:Humans; D008297:Male; D009042:Motivation; D015203:Reproducibility of Results; D012107:Research Design; D012737:Sex Factors; D016540:Smoking Cessation / Q000379:methods*; D013375:Substance Withdrawal Syndrome / Q000453:epidemiology; D014029:Tobacco Use Disorder / Q000628:therapy; D015013:Yoga
keywords: Smoking cessation; Wellness; Yoga