Effects of Yoga and Cardiovascular Exercise on Smoking Motivation

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Behavioral: Hatha Yoga (HY); Behavioral: Smoking Cessation Counseling; Behavioral: Cardiovascular Exercise (CE)

Detailed Description

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
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Hatha Yoga (HY); Exercise and Smoking Cessation Counseling	Behavioral: Hatha Yoga (HY); 3 Sessions of yoga instruction; Other Names: yoga; Behavioral: Smoking Cessation Counseling; 4 smoking cessation counseling visits.; Other Names: control group
EXPERIMENTAL: Cardiovascular Exercise (CE); Exercise and Smoking Cessation Counseling	Behavioral: Smoking Cessation Counseling; 4 smoking cessation counseling visits.; Other Names: control group; Behavioral: Cardiovascular Exercise (CE); 3 sessions of cardiovascular exercise; Other Names: exercise
OTHER: Smoking Cessation Counseling Only; Control Group - Smoking Cessation Counseling	Behavioral: Smoking Cessation Counseling; 4 smoking cessation counseling visits.; Other Names: control group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: David J. Drobes, Ph.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2007
• Primary Completion (ACTUAL): May 2, 2011
• Study Completion (ACTUAL): June 20, 2017

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: August 25, 2011
• First Posted (ESTIMATE): August 26, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 23, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: craving; prevention; quit smoking; mood; cue reactivity; cardiovascular exercise; smoking behavior; Hatha yoga
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: MCC-15245

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No