Effects of Yoga and Cardiovascular Exercise on Smoking Motivation

Study Overview
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Brief Summary
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The overall purpose of this pilot study is to examine effects of Hatha yoga and cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our preliminary study indicated that a single session of either form of activity intervention improved mood, and the yoga intervention appeared to decrease cravings to smoke. The proposed study will extend this preliminary research in several ways.

Detailed Description
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First, the investigators will expand the exercise-based interventions from one to three sessions, which will more closely resemble how these interventions may be used in the context of smoking cessation. Second, the investigators will recruit smokers who are motivated to quit smoking, further increasing the clinical relevance of the research. Finally, the investigators will examine the effects of the interventions on actual smoking behavior within and outside of the laboratory setting. This may appropriately be considered a proof of concept study, as the investigators will not be powered to detect treatment outcome (smoking cessation) differences, nor are the interventions designed to maximize clinical smoking cessation outcomes. Participants will be randomized to receive 3-sessions of yoga instruction, 3-sessions of cardiovascular exercise, or to a no activity control group. Sessions will be scheduled to occur approximately 7 days apart, with a minimum of 4 between sessions. Mood and craving will be assessed before and after each session, and smoking behavior will be assessed following each session. Finally, a detailed cue reactivity assessment will be conducted prior to the first session and following the last session. Analyses will examine intervention effects on craving, mood, cue reactivity, and smoking behavior. In addition, the investigators will examine several potential mediators and moderators of intervention effects on smoking behavior. Finally, the investigators will continue to examine the feasibility and potential acceptability of each active intervention, to assist in developing future clinical applications of these techniques in the context of smoking cessation.

Official Title
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Effects of Yoga and Cardiovascular Exercise on Smoking Motivation

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Behavioral: Hatha Yoga (HY)
* Behavioral: Cardiovascular Exercise (CE)
* Behavioral: Smoking Cessation Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoke at least 10 cigarettes per day Smoked regularly at least 2 years Carbon monoxide reading at least 8 ppm Interest in quitting smoking Able to read and understand the consent form and questionnaires Not currently practicing yoga Exclusion Criteria: Current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) (American Psychiatric Association, 1994) psychosis Major depressive episode, manic episode, or panic disorder Current DSM-IV psychoactive substance dependence or use Current medication use that might affect physiological responses Current use of bupropion, varenicline, or nicotine-containing products other than cigarettes Significant health problems that might compromise physiological data collection or be contraindicated for moderate physical exercise or yoga Significant hearing or visual impairment; pregnant as determined by urine human chorionic gonadotropin (hCG) test or nursing females Body mass index (BMI) 35 or greater

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hatha Yoga (HY)<br>Exercise and Smoking Cessation Counseling | Behavioral: Hatha Yoga (HY)<br>* 3 Sessions of yoga instruction<br>* Other names: yoga;Behavioral: Smoking Cessation Counseling<br>* 4 smoking cessation counseling visits.<br>* Other names: control group;|
| Experimental: Cardiovascular Exercise (CE)<br>Exercise and Smoking Cessation Counseling | Behavioral: Cardiovascular Exercise (CE)<br>* 3 sessions of cardiovascular exercise<br>* Other names: exercise;Behavioral: Smoking Cessation Counseling<br>* 4 smoking cessation counseling visits.<br>* Other names: control group;|
| Other: Smoking Cessation Counseling Only<br>Control Group - Smoking Cessation Counseling | Behavioral: Smoking Cessation Counseling<br>* 4 smoking cessation counseling visits.<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Reporting Post Intervention Effects | Intervention effects on measures of craving, mood, cue reactivity, and smoking behavior will be analyzed with mixed-design analysis of variance (ANOVA), with Intervention as the between-group factor (HY vs. CE vs. NA), and Time as a within-subject factor (pre vs. post-intervention). Analyses for cue reactivity variables will include the additional within-subject factor of Cue Type (smoking vs. neutral), and analyses for craving and mood self-report will include the additional within-subject factor of Session (1 vs. 2 vs. 3). | Average of 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Behavior Changes Post Intervention | In order to determine whether intervention effects on smoking behavior are mediated by changes in craving, mood, and/or cue reactivity, we will conduct Sobel tests (e.g., Preacher & Leonardelli, 2001), supplemented by mediation analyses using methods of Baron & Kenny (1986). | Average of 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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craving, mood, cue reactivity, smoking behavior, quit smoking, prevention, Hatha yoga, cardiovascular exercise