Affect Regulation Training for Pregnant Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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affect regulation training

Group Type EXPERIMENTAL

affect regulation training

Intervention Type BEHAVIORAL

8 sessions of a 1-hour long treatment intended to help women deal more effectively with negative affect; cognitive-behavioral smoking cessation intervention

health and lifestyle

Group Type ACTIVE_COMPARATOR

health and lifestyle

Intervention Type BEHAVIORAL

8 sessions of a 1-hour long treatment designed to help women improve their overall health; cognitive-behavioral smoking cessation intervention

Interventions

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affect regulation training

8 sessions of a 1-hour long treatment intended to help women deal more effectively with negative affect; cognitive-behavioral smoking cessation intervention

Intervention Type BEHAVIORAL

health and lifestyle

8 sessions of a 1-hour long treatment designed to help women improve their overall health; cognitive-behavioral smoking cessation intervention

Intervention Type BEHAVIORAL

Eligibility 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.