View Clinical Trial (Medical Research Study)
Affect Regulation Training for Pregnant Smokers
| City: |
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Buffalo |
| State: |
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New York |
| Zip Code: |
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14203 |
| Conditions: |
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Smoking Cessation |
| Purpose: |
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Recent data indicate that approximately one-third of women of childbearing age smoke
cigarettes, and 25-50% of women smoke during pregnancy. Cigarette smoking during pregnancy
is a significant public health issue that can have profound effects on women's health and
the health of their developing fetus. Smoking among pregnant women is associated with high
levels of negative affect, which play a key role in the maintenance of smoking behavior and
in difficulty quitting smoking during pregnancy. Despite the clear role of negative affect
in the maintenance of smoking among pregnant women, and while this issue has received
increased attention by clinicians and researchers, the investigators know of no smoking
cessation intervention that combines coping skills and emotion regulation approaches to
address the role of negative affect in smoking cessation. Smoking cessation treatment
strategies that have demonstrated effectiveness in regular smokers have not translated into
effective treatment strategies for pregnant women, particularly low-income pregnant women.
The goal of this project is to develop and test an affect regulation smoking cessation
intervention for low-income pregnant smokers.
The major aims of this project will be addressed in two sequential phases. In Phase 1, the
investigators will develop two 8-session smoking cessation treatment manuals including: (a)
Affect Regulation Training plus Cognitive-Behavioral Treatment (ART+CBT) and (b) a Health
and Lifestyle plus Cognitive-Behavioral Treatment (HLS+CBT) control intervention. In Phase
2, the investigators will conduct a randomized clinical trial pilot study (Total N = 60) to
compare the ART+CBT and HLS+CBT conditions on: a) the feasibility and acceptability of the
interventions, (b) the impact of these interventions (ART+CBT and HLS+CBT) on smoking
cessation rates at the end of the 8 treatment sessions (these occur approximately 2 months
after treatment initiation) and at the 6-month post-quit date assessment (Session 2 is the
quit date), (c) affect regulation skills, and (d) negative affect among pregnant smokers.
The long-term goal of this proposed research is to increase smoking cessation rates among
pregnant smokers, which would provide significant long-term health benefits for both mothers
and their infants. This Stage 1 application will be used to generate feasibility and
preliminary efficacy data, setting the stage for a Stage II efficacy trial.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- 18-40 years of age,
- pregnancy involving single birth,
- less than 24 weeks pregnant,
- negative affect smoker,
- smoking at least 1 cigarette per day,
- no substance abuse diagnosis except marijuana,
- no more than .50 ounces of ethanol per day,
- can provide a collateral to verify smoking information.
Exclusion Criteria:
- acute psychosis,
- lack of familiarity with the English language.
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| NCT ID: |
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NCT01163864 |
| Primary Contact: |
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Principal Investigator
Clara Bradizza, Ph.D.
University at Buffalo
Clara M Bradizza, Ph.D.
Phone: 716-887-2532 ext. -
Email: bradizza@ria.buffalo.edu
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| Backup Contact: |
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Email: lwikdander@ria.buffalo.edu
Laurie Wikander
Phone: 716-887-3302 ext. -
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| Location Contact: |
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Buffalo, New York 14203
United States
Clara M Bradizza, Ph.D.
Phone: 716-887-2532
Email: bradizza@ria.buffalo.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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