Affect Regulation Training for Pregnant Smokers
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|ClinicalTrials.gov Identifier: NCT01163864|
Recruitment Status : Unknown
Verified March 2011 by State University of New York at Buffalo.
Recruitment status was: Recruiting
First Posted : July 16, 2010
Last Update Posted : March 9, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: affect regulation training Behavioral: health and lifestyle||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Affect Regulation Training for Pregnant Smokers|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||November 2011|
|Estimated Study Completion Date :||November 2011|
|Experimental: affect regulation training||
Behavioral: 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
|Active Comparator: health and lifestyle||
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
- smoking cessation rate [ Time Frame: end of 8 session treatment (about 2 months after treatment initiation) ]We will compare the number of women who are abstinent from smoking in the ART+CBT group vs. the HLS+CBT group
- smoking cessation rate [ Time Frame: 6-month post-quit date (Session 2 is always the quit date) ]We will compare the number of women who are abstinent from cigarettes in the ART+CBT group vs. the HLS+CBT group
- treatment feasibility [ Time Frame: end of 8-session treatment ]We will compare the number of women who complete the 8-session treatment in the ART+CBT vs. he HLS+CBT group.
- treatment acceptability [ Time Frame: end of 8-session treatment ]We will compare the treatment ratings by participants for the ART+CBT group vs. the HLS+CBT group.
- affect regulation skills [ Time Frame: end of 8-session treatment ]We will compare the scores on measures of affect regulation skills of ART+CBT group vs. HLS+CBT group.
- negative affect [ Time Frame: end of 8-session treatment ]We will compare levels of negative at the end of treatment of the ART+CBT group vs. the HLS+CBT group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163864
|Contact: Clara M Bradizza, Ph.D.||email@example.com|
|Contact: Laurie Wikanderfirstname.lastname@example.org|
|United States, New York|
|Research Institute on Addictions, University at Buffalo||Recruiting|
|Buffalo, New York, United States, 14203-1016|
|Contact: Clara M Bradizza, Ph.D. 716-887-2532 email@example.com|
|Contact: Laurie Wikander 716-887-3302 firstname.lastname@example.org|
|Principal Investigator: Clara M Bradizza, Ph.D.|
|Principal Investigator:||Clara Bradizza, Ph.D.||University at Buffalo|