Testing the efficacy of yoga as a complementary therapy for smoking cessation: design and methods of the BreathEasy trial.

INTRODUCTION

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/DESIGN: 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.