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

Abstract

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. 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 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 mechanisms of action (i.e., mediators) underlying intervention efficacy. We will examine 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.

A systematic review and meta-analysis on the effects of yoga on weight-related outcomes

“…, while 127 of those full-texts were excluded (Table 1) (McIver, 2010;Cheung et al, 2012;Corey et al, 2014;LaCroix et al, 2012;Sharma et al, 2013;Singh et al, 2011;Hoogbruin et al, 2012;Lai et al, 2010;Trivedi and Mishra, 2014;Bock et al, 2010;Bock et al, 2014;Cheema et al, 2011;Cohen et al, 2013;Kandula et al, 2013; Neumark-Sztainer et al, 2011;Flaherty, 2014;Guarracino et al, 2006;Ades et al, 2003;Ankad Roopa et al, 2011;Armstrong and Scott Smedley, 2003;Bhutkar et al, 2011;Choudhary and Mishra, 2013;Hunter et al, 2013;Malhotra et al, 2005;Murthy et al, 2011;Nagarathna and Nagendra, 1987;Raj et al, 2011;Ramos-Jimenez et al, 2009;Sarvottam et al, 2013;Satyanarayana et al, 1992;Sivasankaran et al, 2006;Telles et al, 1993;Telles et al, 2010;Thomley et al, 2011;Villien et al, 2005;Yadav et al, 2012;Yadav et al, 2014;Yang and James, 2014;Begum et al, 2012;Cajka et al, 2013;Čajka et al, 2012;…”

Butt Why ? Exploring factors associated with cigarette scavenging behaviors among adult smokers enrolling in a clinical trial for smoking cessation

“…Study procedures were approved by the Miriam Hospital Institutional Review Board. A Full description of study procedures has been published elsewhere (Bock et al, 2014).…”

Yoga as a Complementary Therapy for Smoking Cessation: Results From BreathEasy, a Randomized Clinical Trial

“…A detailed description of the study design and procedures has been published elsewhere. 23 Recruitment and follow-up retention are presented in the consort diagram (Figure 1). All sessions were conducted at a university-affiliated hospital in New England.…”

“…This intervention consisted of group-based cognitive-behavioral therapy for smoking cessation delivered by PhD-level psychologists. 23 Session content was similar to that used in our previous studies 1,4,24 and included planning for the program's targeted quit day (week 4), handling smoking triggers, coping with cravings, and managing withdrawal. A study manual was used to ensure that topics were covered consistently across study arms and multiple cohorts.…”

“…After providing written consent and completing baseline assessments, participants were randomized using a permuted block randomization stratified on gender and level of nicotine dependence (procedural details described elsewhere). 23 All procedures and materials were approved by the Miriam Hospital Clinical Research Review Board (IRB registration no.0000482).…”