Affect Regulation Training for Pregnant Smokers

Phase 1

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: affect regulation training; Behavioral: health and lifestyle

• Registration Number: NCT01163864
• Lead Sponsor: State University of New York at Buffalo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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.

Exclusion Criteria

• acute psychosis,
• lack of familiarity with the English language.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
affect regulation training	affect regulation training	-
health and lifestyle	health and lifestyle	-

Primary Outcome Measures

Name	Time	Method
smoking cessation rate using the Timeline Followback Interview for smoking	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 using the Timeline Followback Interview for smoking

Secondary Outcome Measures

Name	Time	Method
affect regulation skills	end of 8-session treatment	We will compare the scores on measures of affect regulation skills of ART+CBT group vs. HLS+CBT group using the Difficulties in Emotion Regulation Scale (DERS).
smoking cessation rate using the Timelineline Followback Interview for smoking	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 using the Timeline Followback Interview for smoking
negative affect	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 using both Positive and Negative Affect Scale
treatment feasibility	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	end of 8-session treatment	We will compare the treatment ratings by participants for the ART+CBT group vs. the HLS+CBT group using the Treatment Acceptability Questionnaire

Trial Locations

Locations (1)

Research Institute on Addictions, University at Buffalo; 🇺🇸 Buffalo, New York, United States