Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy: A Randomized Pilot Study

Smoking Cessation Clinical Trial

Official title:

Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy: A Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360581
• Other study ID #: 0603012
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2006
• Last updated: February 7, 2008
• Start date: April 2006
• Est. completion date: January 2008

Study information

• Verified date: February 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop strategies to maintain smoking abstinence initiated in pregnancy and prevent relapse in the postpartum period.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Must have the ability to read, write, and understand English.

• Must have quit smoking during their current pregnancy.

• Must possess the desire to remain smoke-free after delivery.

• Obtain permission from obstetrician to participate in yoga.

• Must be reachable by telephone.

• If subject becomes pregnant again while in the study, she can still participate with written permission from her primary care physician.

Exclusion Criteria:

• Untreated hypertension.

• A history of: glaucoma, major depression, alcohol abuse or substance disorder, anorexia nervosa, or head trauma.

• Recent abdominal surgery (such as caesarean section).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Yoga

• Yoga and Cognitive Behavioral Therapy

Locations

Country	Name	City	State
United States	University of Pittsburgh School of Nursing	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking abstinence by CO testing
Secondary	smoking abstinence by self-report