Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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
No
David J. Drobes, Ph.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
MCC-15245
NCT01423578
August 2007
November 2013
Name | Location |
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H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |