Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01163864
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2010-07-13
Brief Title:
Affect Regulation Training for Pregnant Smokers
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
Affect Regulation Training for Pregnant Smokers
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens 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 ARTCBT and b a Health and Lifestyle plus Cognitive-Behavioral Treatment HLSCBT control intervention In Phase 2 the investigators will conduct a randomized clinical trial pilot study Total N 60 to compare the ARTCBT and HLSCBT conditions on a the feasibility and acceptability of the interventions b the impact of these interventions ARTCBT and HLSCBT 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
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 ARTCBT and b a Health and Lifestyle plus Cognitive-Behavioral Treatment HLSCBT control intervention In Phase 2 the investigators will conduct a randomized clinical trial pilot study Total N 60 to compare the ARTCBT and HLSCBT conditions on a the feasibility and acceptability of the interventions b the impact of these interventions ARTCBT and HLSCBT 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA021802 | NIH | None | httpsreporternihgovquickSearchR01DA021802 |