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临床试验/NCT01809678
NCT01809678已完成不适用

Efficacy of Yoga as a Complementary Therapy for Smoking Cessation

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
255
试验地点
2
主要终点
Smoking abstinence

研究概览

简要总结

This study examines the efficacy of yoga as a complementary therapy for smoking cessation

详细描述

Despite the existence of effective medications for smoking cessation, approximately 50-80% of smokers attempt to quit without using pharmacotherapy. Efforts to encourage medication use during cessation attempts have met with mixed success. Many do not use medications because of concerns about side effects, contraindications that make medication use inappropriate, and individual preferences for chemical-free quit attempts. This leaves many smokers seeking an effective alternative to assist them in attempting to quit smoking. Each year, over 41% of smokers report failed attempts to quit smoking. Thus, effective non-pharmacological interventions to increase rates of successful cessation are greatly needed.

Our research, and the research of other investigators, has demonstrated that traditional (Western) exercise (e.g., brisk walking, bicycling) improves smokers' ability to successfully quit. Exercise may help smokers quit by reducing concerns regarding post-cessation weight gain, and by reducing nicotine withdrawal and enhancing mood. Recent research suggests that yoga is an acceptable and potentially effective alternative therapy for smoking cessation for several reasons: As a form of exercise, yoga shares many of the same properties as traditional (Western) aerobic exercise in that yoga has been shown to improve mood, physical fitness, weight control, self-image and quality of life in healthy and ill populations. Moreover, features of yoga, including a focus on breathing, mental concentration, meditation, stress reduction and enhanced mood are likely to have special relevance for smokers who are trying to quit. Thus, yoga may be particularly attractive as an alternative for individuals who either cannot use medications, or who choose not to use medications while quitting.

The proposed study will test the efficacy of Yoga as a complementary therapy for smoking cessation using a randomized, controlled study design. Adult smokers will be randomly assigned to either; 1) Yoga, or 2) an equal contact time Control group (CTL) given a health & wellness program to control for contact time. All participants will be provided (separately by treatment group assignment) with the same cognitive-behavioral Smoking Cessation Counseling (SCC). Smoking abstinence will be measured at the end of treatment (week 8) and at 3, 6 and 12 months follow-up. We hypothesize that abstinence will be significantly higher in the SCC+Yoga group compared to SCC+CTL. We will also test theoretically posited mediators of intervention efficacy (e.g., perceived stress, cognitive/perceptual changes), examine the cost-efficacy of the yoga intervention, and examine the relationship between maintenance of yoga practice during the post-treatment period and smoking status. This study builds on our programmatic line of research developing innovative, theory-driven smoking cessation therapies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older (physician clearance for age > 65)
  • English-speaking
  • Currently Healthy
  • Smoking smoked 5 or more cigarettes/day
  • Must accept randomization procedure
  • Will be Living in RI/MA/CT for next year

排除标准

  • Participated in any Yoga, Tai Chi, Qi Gong or Mindfulness-based therapy program twice in the past month or 10 times within the past year
  • MD refused consent or Unable to obtain MD consent
  • Unable to attend program due to work or home schedule
  • Currently using medications or in active treatment to quit smoking
  • Currently or planned participation in research or treatment programs that would interfere with this study
  • Presence of health conditions that would make participation in yoga difficult or dangerous
  • Medical Exclusion Criteria
  • Cardiovascular disease
  • Stroke/TIA
  • Chest pain with physical activity
  • Current or recent (< 6 months) cancer treatment
  • Uncontrolled Hypertension
  • Untreated major depression or hospitalization < six months
  • Bone joint problems
  • Liver or Kidney Disease
  • Fainting within the past year
  • History of seizures
  • Balance condition that interferes with ability to exercise
  • Respiratory Condition - COPD (e.g., emphysema requiring oxygen)
  • Liver Disease
  • Kidney Disease
  • Other medical condition that would interfere with ability to exercise
  • Hypothyroid (not on stable medication for 3 months)

结局指标

主要结局

Smoking abstinence

时间窗: One year

Abstinence from smoking at 1-year post treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beth Bock, Ph.D.

Staff Psychologist

The Miriam Hospital

研究点 (2)

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