Affect Regulation Training for Pregnant Smokers

October 12, 2022 updated by: Clara Bradizza, State University of New York at Buffalo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203-1016
        • Research Institute on Addictions, University at Buffalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
smoking cessation rate using the Timeline Followback Interview for smoking
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 using the Timeline Followback Interview for smoking
end of 8 session treatment (about 2 months after treatment initiation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
smoking cessation rate using the Timelineline Followback Interview for smoking
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 using the Timeline Followback Interview for smoking
6-month post-quit date (Session 2 is always the quit date)
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.
end of 8-session treatment
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 using the Treatment Acceptability Questionnaire
end of 8-session treatment
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 using the Difficulties in Emotion Regulation Scale (DERS).
end of 8-session treatment
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 using both Positive and Negative Affect Scale
end of 8-session treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Clara Bradizza, Ph.D., University at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Q607
  • R01DA021802 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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