Effects of Yoga and Cardiovascular Exercise on Smoking Motivation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01423578
First received: August 24, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Tobacco Dependence
Behavioral: Hatha Yoga (HY)
Behavioral: Cardiovascular Exercise (CE)
Behavioral: Smoking Cessation Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Yoga and Cardiovascular Exercise on Smoking Motivation

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • The Number of Participants Reporting Post Intervention Effects [ Time Frame: Average of 6 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Average of 6 Months ] [ Designated as safety issue: No ]
    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).


Enrollment: 79
Study Start Date: August 2007
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hatha Yoga (HY)
Exercise and Smoking Cessation Counseling
Behavioral: Hatha Yoga (HY)
3 Sessions of yoga instruction
Other Name: yoga
Behavioral: Smoking Cessation Counseling
4 smoking cessation counseling visits.
Other Name: control group
Experimental: Cardiovascular Exercise (CE)
Exercise and Smoking Cessation Counseling
Behavioral: Cardiovascular Exercise (CE)
3 sessions of cardiovascular exercise
Other Name: exercise
Behavioral: Smoking Cessation Counseling
4 smoking cessation counseling visits.
Other Name: control group
Smoking Cessation Counseling Only
Control Group - Smoking Cessation Counseling
Behavioral: Smoking Cessation Counseling
4 smoking cessation counseling visits.
Other Name: control group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423578

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: David J. Drobes, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01423578     History of Changes
Other Study ID Numbers: MCC-15245
Study First Received: August 24, 2011
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
craving
mood
cue reactivity
smoking behavior
quit smoking
prevention
Hatha yoga
cardiovascular exercise

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014