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NCT01163864 · ClinicalTrials.gov registry record · Phase 1
Affect Regulation Training for Pregnant Smokers
A Phase 1 study, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
NCT01163864 is a Phase 1 study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 77 participants.
The verdict
NCT01163864, a Phase 1 study, has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
Study 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 assessmen
Interventions
- BEHAVIORAL affect regulation training
- BEHAVIORAL health and lifestyle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01163864
The ClinicalTrials.gov registry entry for NCT01163864 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which affect regulation training is the first listed.
NCT01163864 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01163864 about?
NCT01163864 is a clinical study titled "Affect Regulation Training for Pregnant Smokers". 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 fet...
What is the current status of trial NCT01163864?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2007-09. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01163864?
The interventions under investigation include: affect regulation training (BEHAVIORAL), health and lifestyle (BEHAVIORAL).
Who is sponsoring clinical trial NCT01163864?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
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