Bock Beth C, Rosen Rochelle K, Fava Joseph L, Gaskins Ronnesia B, Jennings Ernestine, Thind Herpreet, Carmody James, Dunsiger Shira I, Gidron Naama, Becker Bruce M, Marcus Bess H
Alpert Medical School of Brown University, The Miriam Hospital, 167 Point Street, Providence, RI 02903, USA.
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.
Contemp Clin Trials. 2014 Jul;38(2):321-32. doi: 10.1016/j.cct.2014.06.003. Epub 2014 Jun 14.
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.
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.
试图戒烟的吸烟者会遇到许多挑战，包括尼古丁戒断症状、对香烟的渴望、压力增加、情绪消极以及对体重增加的担忧。这些现象使得成功戒烟变得困难。对非吸烟人群的研究表明，瑜伽可以减轻压力和消极情绪，并改善体重控制。通过增强正念，我们预计瑜伽还可能提高吸烟者应对与戒烟相关消极症状的能力。瑜伽还可能改善认知思考能力，而这是在诱人情境中做出有效选择并避免吸烟所必需的。
方法/设计：“轻松呼吸”研究是一项严格的随机对照临床试验，旨在检验艾扬格瑜伽作为戒烟认知行为疗法辅助疗法的疗效。所有参与者都参加为期8周的戒烟课程，并被随机分为两组，一组每周参加两次瑜伽课程（瑜伽组），另一组每周参加两次健康与养生课程，后者作为接触和参与者负担的对照组（对照组）。在基线、8周、3个月、6个月和12个月的随访时进行评估。主要结局是采用意向性分析方法评估的延长戒烟时间。采用盲态数据收集进行多次内部和外部审核，以确保治疗的保真度和研究结果的可靠性。为了理解为什么瑜伽可能比对照组更有效，我们将研究干预效果背后的作用机制（即中介因素）。我们将在每次随访时检查瑜伽练习和吸烟状态的维持情况。焦点小组和访谈将用于丰富我们对瑜伽练习与戒烟关系的理解。
本研究将对瑜伽与控制接触时间和注意力的条件相比的相对疗效进行严格测试。混合方法的使用也提供了验证关于瑜伽现有知识的机会，并有助于探索未来正念和瑜伽研究的新主题。
