Affect Regulation Training for Pregnant Smokers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by State University of New York at Buffalo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01163864
First received: July 13, 2010
Last updated: March 7, 2011
Last verified: March 2011

July 13, 2010
March 7, 2011
September 2007
November 2011   (final data collection date for primary outcome measure)
smoking cessation rate [ Time Frame: end of 8 session treatment (about 2 months after treatment initiation) ] [ Designated as safety issue: No ]
We will compare the number of women who are abstinent from smoking in the ART+CBT group vs. the HLS+CBT group
Same as current
Complete list of historical versions of study NCT01163864 on ClinicalTrials.gov Archive Site
  • smoking cessation rate [ Time Frame: 6-month post-quit date (Session 2 is always the quit date) ] [ Designated as safety issue: No ]
    We will compare the number of women who are abstinent from cigarettes in the ART+CBT group vs. the HLS+CBT group
  • treatment feasibility [ Time Frame: end of 8-session treatment ] [ Designated as safety issue: No ]
    We will compare the number of women who complete the 8-session treatment in the ART+CBT vs. he HLS+CBT group.
  • treatment acceptability [ Time Frame: end of 8-session treatment ] [ Designated as safety issue: No ]
    We will compare the treatment ratings by participants for the ART+CBT group vs. the HLS+CBT group.
  • affect regulation skills [ Time Frame: end of 8-session treatment ] [ Designated as safety issue: No ]
    We will compare the scores on measures of affect regulation skills of ART+CBT group vs. HLS+CBT group.
  • negative affect [ Time Frame: end of 8-session treatment ] [ Designated as safety issue: No ]
    We will compare levels of negative at the end of treatment of the ART+CBT group vs. the HLS+CBT group.
Same as current
Not Provided
Not Provided
 
Affect Regulation Training for Pregnant Smokers
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 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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Smoking Cessation
  • 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
  • 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
  • Experimental: affect regulation training
    Intervention: Behavioral: affect regulation training
  • Active Comparator: health and lifestyle
    Intervention: Behavioral: health and lifestyle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
Yes
Contact: Clara M Bradizza, Ph.D. 716-887-2532 ext - bradizza@ria.buffalo.edu
Contact: Laurie Wikander 716-887-3302 ext - lwikdander@ria.buffalo.edu
United States
 
NCT01163864
Q607, R01DA021802
Yes
Clara M. Bradizza, Ph.D., Research Institute on Addictions, University at Buffalo
State University of New York at Buffalo
National Institute on Drug Abuse (NIDA)
Principal Investigator: Clara Bradizza, Ph.D. University at Buffalo
State University of New York at Buffalo
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP