Affect Regulation Training for Pregnant Smokers

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Smoking Cessation

Clinical Trial Details

NCT number	NCT01163864
Study type	Interventional
Source	State University of New York at Buffalo
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	September 2007
Completion date	November 2011

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.