Yoga as a Complementary Therapy for Smoking Cessation
Primary Purpose
Tobacco Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking Cessation
Yoga
Wellness
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Dependence focused on measuring Smoking, Tobacco, Yoga
Eligibility 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)
Sites / Locations
- The Miriam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Smoking Cessation plus Yoga
Smoking Cessation plus Wellness
Arm Description
Twice weekly, 1-hour yoga classes delivered for 8 weeks combined with once-weekly, 1-hour cognitive-behavioral smoking cessation classes.
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
Outcomes
Primary Outcome Measures
Smoking abstinence
Abstinence from smoking at 1-year post treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01809678
Brief Title
Yoga as a Complementary Therapy for Smoking Cessation
Official Title
Efficacy of Yoga as a Complementary Therapy for Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study examines the efficacy of yoga as a complementary therapy for smoking cessation
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
Smoking, Tobacco, Yoga
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
255 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smoking Cessation plus Yoga
Arm Type
Experimental
Arm Description
Twice weekly, 1-hour yoga classes delivered for 8 weeks combined with once-weekly, 1-hour cognitive-behavioral smoking cessation classes.
Arm Title
Smoking Cessation plus Wellness
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Smoking Cessation
Intervention Description
Once weekly program of cognitive-behavioral therapy for smoking cessation
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
Twice weekly program of 1-hour Iyengar yoga classes
Intervention Type
Other
Intervention Name(s)
Wellness
Intervention Description
Twice weekly program of 1-hour wellness classes on a variety of health topics.
Primary Outcome Measure Information:
Title
Smoking abstinence
Description
Abstinence from smoking at 1-year post treatment
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27683623
Citation
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.
Results Reference
background
PubMed Identifier
24937018
Citation
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.
Results Reference
background
PubMed Identifier
30295912
Citation
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.
Results Reference
result
PubMed Identifier
29025502
Citation
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.
Results Reference
result
PubMed Identifier
27797659
Citation
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.
Results Reference
result
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Yoga as a Complementary Therapy for Smoking Cessation
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