Affect Regulation Training for Pregnant Smokers
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    


Intervention name(s): affect regulation training; health and lifestyle
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 sessions of a 1-hour long treatment intended to help women deal more effectively with negative affect; cognitive-behavioral smoking cessation intervention; 8 sessions of a 1-hour long treatment designed to help women improve their overall health; cognitive-behavioral smoking cessation intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking; smoking relapse; smoking cessation; pregnancy; smoking cessation in pregnant women