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Affect Regulation Training for Pregnant Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01163864
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : October 17, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Clara Bradizza, State University of New York at Buffalo

Study Description
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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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: affect regulation training Behavioral: health and lifestyle Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Affect Regulation Training for Pregnant Smokers
Study Start Date : September 2007
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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).

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163864


Locations
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United States, New York
Research Institute on Addictions, University at Buffalo
Buffalo, New York, United States, 14203-1016
Sponsors and Collaborators
State University of New York at Buffalo
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Clara Bradizza, Ph.D. University at Buffalo
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clara Bradizza, Senior Research Scientist, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01163864    
Other Study ID Numbers: Q607
R01DA021802 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022
Keywords provided by Clara Bradizza, State University of New York at Buffalo:
smoking
smoking relapse
smoking cessation
pregnancy
smoking cessation in pregnant women