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
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Behavioral: affect regulation training
Behavioral: health and lifestyle
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Affect Regulation Training for Pregnant Smokers

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: September 2007
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163864

Contacts
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

Locations
United States, New York
Research Institute on Addictions, University at Buffalo Recruiting
Buffalo, New York, United States, 14203-1016
Contact: Clara M Bradizza, Ph.D.    716-887-2532    bradizza@ria.buffalo.edu   
Contact: Laurie Wikander    716-887-3302    lwikander@ria.buffalo.edu   
Principal Investigator: Clara M Bradizza, Ph.D.         
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Principal Investigator: Clara Bradizza, Ph.D. University at Buffalo
  More Information

Additional Information:
No publications provided

Responsible Party: Clara M. Bradizza, Ph.D., Research Institute on Addictions, University at Buffalo
ClinicalTrials.gov Identifier: NCT01163864     History of Changes
Other Study ID Numbers: Q607, R01DA021802
Study First Received: July 13, 2010
Last Updated: March 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:
smoking
smoking relapse
smoking cessation
pregnancy
smoking cessation in pregnant women

ClinicalTrials.gov processed this record on August 21, 2014