Efficacy of Yoga as a Complementary Therapy for Smoking Cessation
Smoking Cessation
+ Yoga
+ Smoking Cessation
Behavior+3
+ Mental Disorders
+ Substance-Related Disorders
Treatment Study
Summary
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.255 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 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 BMI< 40 Will be Living in RI/MA/CT for next year Exclusion Criteria: 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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location