Viewing Study NCT00360581



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Study NCT ID: NCT00360581
Status: COMPLETED
Last Update Posted: 2008-02-11
First Post: 2006-08-02

Brief Title: Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy A Randomized Pilot Study
Sponsor: University of Pittsburgh
Organization: University of Pittsburgh

Study Overview

Official Title: Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy A Randomized Pilot Study
Status: COMPLETED
Status Verified Date: 2008-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to develop strategies to maintain smoking abstinence initiated in pregnancy and prevent relapse in the postpartum period
Detailed Description: Many women quit smoking during pregnancy but postpartum relapse rates are high approximately 50-80 Vant 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None