View Clinical Trial (Medical Research Study)
Addressing Postpartum Mood and Weight Concerns to Sustain Smoking Cessation
| City: |
|
Pittsburgh |
| State: |
|
Pennsylvania |
| Zip Code: |
|
15213 |
| Conditions: |
|
Smoking |
| Purpose: |
|
The purpose of this study is to evaluate the relative efficacy of a postpartum smoking
relapse prevention program, Strategies to Avoid Returning to Smoking (STARTS), and a
supportive, nondirective comparison condition (SUPPORT) to increase the proportion of women
who remain abstinent through 12 months postpartum. We hypothesize that women randomized to
STARTS will maintain higher rates of smoking abstinence at 6 and 12 months postpartum, and
expect STARTS to increase the length of time abstinence is sustained relative to SUPPORT.
|
| Study Summary: |
|
The goal of the proposed investigation is to determine whether a cognitive behavioral
relapse prevention intervention designed to address mood and weight concerns during the
postpartum period will decrease the rate of postpartum relapse to smoking. We propose a
two-group, randomized controlled trial. Women who quit smoking as a result of pregnancy,
have been quit for at least one month prior to delivery and are motivated to remain
abstinent postpartum will complete baseline assessments and be randomly assigned during the
third trimester of pregnancy to either a cognitive behavioral relapse prevention
intervention specifically designed for women who quit smoking during pregnancy, Strategies
to Avoid Returning To Smoking (STARTS), or a nonspecific, supportive condition (SUPPORT).
Both conditions will receive written information on the dangers of postpartum smoking and an
equivalent number and amount of sessions immediately prior to delivery and during the first
six months postpartum. Women will be treated for the first six months postpartum because
substantial evidence has shown the risk of relapse to be greatest during the six months
immediately following delivery (McBride et al., 1990; Mullen et al., 1990). All women will
complete assessments at baseline (during pregnancy) and 3, 6 and 12 months postpartum.
|
| Criteria: |
|
Inclusion Criteria:
- Women will be eligible to participate if they:
- report having smoked daily for at least one month during the 3 months prior to
becoming pregnant;
- smoked at least 10 cigarettes per day before quitting;
- report no smoking in the four weeks prior to enrollment;
- are not currently smoking as verified by a CO less than 8ppm;
- are at least 'somewhat' motivated to remain abstinent postpartum and
- are at least 14 years of age.
Exclusion Criteria:
- Women with current, acute psychiatric disorders, including other substance use
problems and symptoms that warrant immediate treatment will be referred for care and
excluded from this trial.
- Women with psychiatric disorders (e.g., depressive or anxiety disorders), who are not
acutely suicidal and in whom the symptoms are not severe enough to preclude
participation in a randomized trial, will be eligible to participate. However, women
taking psychiatric medications that may affect the mediators of treatment, such as
antidepressant, anxiolytic or weight control medications, will be excluded from
participation.
- Women who endorse current suicidality will be discussed immediately with the
consulting physician and referred to the psychiatric emergency room for further
evaluation as indicated.
|
| NCT ID: |
|
NCT00757068 |
| Primary Contact: |
|
Principal Investigator
Michele D Levine, PhD
University of Pittsburgh
Meghan C Wisinski, BS
Phone: 412-647-9230
Email: curriems@upmc.edu
|
| Backup Contact: |
|
Email: levinem@upmc.edu
Michele D Levine, PhD
Phone: 412-647-0703
|
| Location Contact: |
|
Pittsburgh, Pennsylvania 15213
United States
Meghan S Wisinski, BS
Phone: 412-647-9230
Email: curriems@upmc.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 21, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|