Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
Primary Purpose
Tobacco Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hatha Yoga (HY)
Cardiovascular Exercise (CE)
Smoking Cessation Counseling
Sponsored by
About this trial
This is an interventional prevention trial for Tobacco Dependence focused on measuring craving, mood, cue reactivity, smoking behavior, quit smoking, prevention, Hatha yoga, cardiovascular exercise
Eligibility Criteria
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
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Other
Arm Label
Hatha Yoga (HY)
Cardiovascular Exercise (CE)
Smoking Cessation Counseling Only
Arm Description
Exercise and Smoking Cessation Counseling
Exercise and Smoking Cessation Counseling
Control Group - Smoking Cessation Counseling
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT01423578
First Posted
August 24, 2011
Last Updated
June 23, 2017
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01423578
Brief Title
Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
Official Title
Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 21, 2007 (Actual)
Primary Completion Date
May 2, 2011 (Actual)
Study Completion Date
June 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
craving, mood, cue reactivity, smoking behavior, quit smoking, prevention, Hatha yoga, cardiovascular exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hatha Yoga (HY)
Arm Type
Active Comparator
Arm Description
Exercise and Smoking Cessation Counseling
Arm Title
Cardiovascular Exercise (CE)
Arm Type
Experimental
Arm Description
Exercise and Smoking Cessation Counseling
Arm Title
Smoking Cessation Counseling Only
Arm Type
Other
Arm Description
Control Group - Smoking Cessation Counseling
Intervention Type
Behavioral
Intervention Name(s)
Hatha Yoga (HY)
Other Intervention Name(s)
yoga
Intervention Description
3 Sessions of yoga instruction
Intervention Type
Behavioral
Intervention Name(s)
Cardiovascular Exercise (CE)
Other Intervention Name(s)
exercise
Intervention Description
3 sessions of cardiovascular exercise
Intervention Type
Behavioral
Intervention Name(s)
Smoking Cessation Counseling
Other Intervention Name(s)
control group
Intervention Description
4 smoking cessation counseling visits.
Primary Outcome Measure Information:
Title
The Number of Participants Reporting Post Intervention Effects
Description
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 Outcome Measure Information:
Title
Number of Participants Reporting Behavior Changes Post Intervention
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Drobes, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
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Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
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