Affect Regulation Training for Pregnant Smokers
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 13, 2010 | ||||||||
| Last Updated Date | March 7, 2011 | ||||||||
| Start Date ICMJE | September 2007 | ||||||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
smoking cessation rate [ Time Frame: end of 8 session treatment (about 2 months after treatment initiation) ] [ Designated as safety issue: No ] We will compare the number of women who are abstinent from smoking in the ART+CBT group vs. the HLS+CBT group |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01163864 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Affect Regulation Training for Pregnant Smokers | ||||||||
| Official Title ICMJE | Affect Regulation Training for Pregnant Smokers | ||||||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Smoking Cessation | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | November 2011 | ||||||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01163864 | ||||||||
| Other Study ID Numbers ICMJE | Q607, R01DA021802 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Clara M. Bradizza, Ph.D., Research Institute on Addictions, University at Buffalo | ||||||||
| Study Sponsor ICMJE | State University of New York at Buffalo | ||||||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||
| Investigators ICMJE |
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| Information Provided By | State University of New York at Buffalo | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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