Effects of Yoga and Cardiovascular Exercise on Smoking Motivation

H. Lee Moffitt Cancer Center and Research Institute79 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Tobacco Dependence

Interventions

Hatha Yoga (HY)BEHAVIORAL

3 Sessions of yoga instruction

Cardiovascular Exercise (CE)BEHAVIORAL

3 sessions of cardiovascular exercise

Smoking Cessation CounselingBEHAVIORAL

4 smoking cessation counseling visits.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: Average of 6 Months

Secondary Outcomes

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).

Time frame: Average of 6 Months

Data from ClinicalTrials.gov

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