Yoga for Men Attempting Smoking Cessation

Study Overview
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Brief Summary
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The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a quit-smoking program that combines behavioral therapy with either yoga, or a health & wellness program that serves as a contact control.

Detailed Description
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Men enrolled in this pilot will be provided with 8 weeks of cognitive-behavioral therapy for smoking cessation and either 1) a twice-weekly program of yoga, or 2) a health & wellness program that serves as a control for number of contacts and subject burden between study conditions. Qualitative data from open ended surveys and interviews is used to supplement survey data to enhance the investigators understanding of study outcomes. Participant accrual and retention rates, acceptance of randomization, and compliance with study protocols will be examined along with perceptions and beliefs about yoga and its relationship to quitting smoking specifically, and health in general.

Official Title
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Complementary Treatments for Smoking Cessation

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Smoking Cessation
* Behavioral: Yoga
* Behavioral: Health & Wellness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male age 18 -65 daily smoker, 5 or more cigarettes/day generally healthy able to exercise safely Exclusion Criteria: female hypertension current or recent history of medication use for major depression participation in yoga classes within the past year current or >1 year prior experience with mind/body therapies currently participating in regular exercise classes currently enrolled in quit smoking program currently using quit smoking medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>One-hour sessions of twice weekly yoga for 8 weeks. | Behavioral: Cognitive Behavioral Therapy for Smoking Cessation<br>* one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation<br>Behavioral: Yoga<br>* One hour, twice weekly for 8 weeks of vinyasa yoga<br>|
| Active Comparator: Health & Wellness<br>8 week program of health & wellness classes, materials and handouts. Topics included healthy eating, cancer prevention and cardiovascular disease prevention. | Behavioral: Cognitive Behavioral Therapy for Smoking Cessation<br>* one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation<br>Behavioral: Health & Wellness<br>* Lectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence | 7-day point prevalence abstinence was measured at 8 weeks, 3 and 6 months follow up | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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men, Smoking, yoga, intervention