Affect Regulation Training for Pregnant Smokers

NCT01163864 | Completed Phase 1 DMC

• 2 other identifiers: Q607R01DA021802
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

smoking; smoking relapse; smoking cessation; pregnancy; smoking cessation in pregnant women

Outcome Measures

Primary Outcomes (1)

• smoking cessation rate using the Timeline Followback Interview for smoking

  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 Outcomes (5)

• smoking cessation rate using the Timelineline Followback Interview for smoking

  6-month post-quit date (Session 2 is always the quit date)

• treatment feasibility

  end of 8-session treatment

• treatment acceptability

  end of 8-session treatment

• affect regulation skills

  end of 8-session treatment

• negative affect

  end of 8-session treatment

Study Arms (2)

affect regulation training

EXPERIMENTAL

Behavioral: affect regulation training

health and lifestyle

ACTIVE COMPARATOR

Behavioral: health and lifestyle

Interventions

affect regulation training BEHAVIORAL

8 sessions of a 1-hour long treatment intended to help women deal more effectively with negative affect; cognitive-behavioral smoking cessation intervention

affect regulation training

health and lifestyle BEHAVIORAL

8 sessions of a 1-hour long treatment designed to help women improve their overall health; cognitive-behavioral smoking cessation intervention

health and lifestyle

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Research Institute on Addictions, University at Buffalo

Buffalo, New York, 14203-1016, United States

Location

Related Publications (1)

• Fillo J, Kamper-DeMarco KE, Brown WC, Stasiewicz PR, Bradizza CM. Emotion regulation difficulties and social control correlates of smoking among pregnant women trying to quit. Addict Behav. 2019 Feb;89:104-112. doi: 10.1016/j.addbeh.2018.09.033. Epub 2018 Sep 26.

  PMID: 30286396 DERIVED

Related Links

• Research Institute on Addiction website
• Description of project on institutional website

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Health

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Clara Bradizza, Ph.D.

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 16, 2010
• Study Start: September 1, 2007
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

US (1)