- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01809678
Yoga as a Complementary Therapy for Smoking Cessation
Efficacy of Yoga as a Complementary Therapy for Smoking Cessation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
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Providence, Rhode Island, United States, 02906
- The Miriam Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smoking Cessation plus Yoga
Twice weekly, 1-hour yoga classes delivered for 8 weeks combined with once-weekly, 1-hour cognitive-behavioral smoking cessation classes.
|
Once weekly program of cognitive-behavioral therapy for smoking cessation
Twice weekly program of 1-hour Iyengar yoga classes
|
|
Active Comparator: Smoking Cessation plus Wellness
Twice-weekly, 1-hour Wellness classes given on a variety of health topics twice weekly to match schedule of the yoga classes, plus 1-hour per week of cognitive-behavioral smoking cessation
|
Once weekly program of cognitive-behavioral therapy for smoking cessation
Twice weekly program of 1-hour wellness classes on a variety of health topics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking abstinence
Time Frame: One year
|
Abstinence from smoking at 1-year post treatment
|
One year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Thind H, Jennings E, Fava JL, Sillice MA, Becker BM, Hartman SJ, Bock BC. Differences between Men and Women Enrolling in Smoking Cessation Programs Using Yoga as a Complementary Therapy. J Yoga Phys Ther. 2016;6(3):245. doi: 10.4172/2157-7595.1000245. Epub 2016 Jun 15.
- Bock BC, Rosen RK, Fava JL, Gaskins RB, Jennings E, Thind H, Carmody J, Dunsiger SI, Gidron N, Becker BM, Marcus BH. Testing the efficacy of yoga as a complementary therapy for smoking cessation: design and methods of the BreathEasy trial. Contemp Clin Trials. 2014 Jul;38(2):321-32. doi: 10.1016/j.cct.2014.06.003. Epub 2014 Jun 14.
- Bock BC, Dunsiger SI, Rosen RK, Thind H, Jennings E, Fava JL, Becker BM, Carmody J, Marcus BH. Yoga as a Complementary Therapy for Smoking Cessation: Results From BreathEasy, a Randomized Clinical Trial. Nicotine Tob Res. 2019 Oct 26;21(11):1517-1523. doi: 10.1093/ntr/nty212.
- Bock BC, Thind H, Dunsiger S, Fava JL, Jennings E, Becker BM, Marcus BH, Rosen RK, Sillice MA. Who Enrolls in a Quit Smoking Program with Yoga Therapy? Am J Health Behav. 2017 Nov 1;41(6):740-749. doi: 10.5993/AJHB.41.6.8.
- Rosen RK, Thind H, Jennings E, Guthrie KM, Williams DM, Bock BC. "Smoking Does Not Go With Yoga:" A Qualitative Study of Women's Phenomenological Perceptions During Yoga and Smoking Cessation. Int J Yoga Therap. 2016 Jan;26(1):33-41. doi: 10.17761/1531-2054-26.1.33.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AT006948 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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