Smoking Cessation Clinical Trial
Official title:
Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy: A Randomized Pilot Study
The purpose of this study is to develop strategies to maintain smoking abstinence initiated in pregnancy and prevent relapse in the postpartum period.
Many women quit smoking during pregnancy, but postpartum relapse rates are high,
approximately, 50-80% (Van't Hof, et al). The majority of women who quit smoking during
pregnancy resume smoking within the first 3 months postpartum (McBride, et al). The
environmental risks of tobacco smoke on the newborn child can lead to acute respiratory
infections, bronchitis, pneumonia, and SIDS. Several studies have tried to identify reasons
for the high rates of relapse. Postpartum relapse has been attributed to decreased
self-efficacy, the lack of effective coping strategies to resist temptation to smoke, and
weight concerns (McBride, et al). Addictive behaviors such as smoking are learned behavioral
means of coping. By learning new rules for dealing with problems, a behavior can be modified
or unlearned. Physical exercise, when combined with cognitive behavioral therapy (CBT) as a
smoking cessation treatment, is useful in the maintenance of smoking cessation in women.
Yoga, as a form of exercise, has been shown to promote the desire to stop smoking and
enhance subjective well-being and mood. Though untested in postpartum relapse prevention,
yoga practice, when coupled with CBT, may address both mood and physiologic postpartum
sensations that may be associated with the prevention of smoking relapse. Women are more apt
to decrease or even stop smoking during pregnancy, and if successful in sustaining
cessation, are likely to live longer.
This randomized exploratory pilot study will use a controlled parallel group design using
smoking cessation yoga intervention and cognitive behavioral therapy. The study will include
a total of 30 participants aged 18-45 years. Smoking status will be identified by
self-report and carbon monoxide testing at enrollment. At randomization and following time
points, smoking status will be identified by self-report and confirmed by carbon monoxide
testing.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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