The majority of studies evaluating smoking cessation treatments for pregnant smokers have employed minimal intervention strategies that have achieved limited success. We believe a significant reason for this lack of efficacy is the failure of minimal treatment approaches to address symptoms of depression and stress among pregnant smokers who fail to quit on their own. Data from our recently completed trial of a videotape smoking cessation intervention for pregnant smokers indicated that significant levels of affective impairment were present in this group. Over 50 percent of the women met DSM-IV criteria for major depression on the Prime MD, or had CES-D scores > 16. Depressive symptoms were frequently chronic. In addition, research indicates that high levels of stress, poor coping resources, and low levels of social support satisfaction are predictive of depression and continued smoking during pregnancy. The proposed study will address these issues by evaluating the efficacy of an intervention designed to impact these risk factors. Approximately 375 women will be randomized to either a mood management (MM) intervention, health education (HE), or usual care (UC) control condition. The MM and HE interventions will be delivered in 7 60-minute counseling sessions that will incorporate 10 minutes of brief smoking cessation counseling based on the Clinical Practice Guidelines that will include a specific focus on smoking and pregnancy. Participants in the MM condition will receive an additional 50 minutes of counseling emphasizing the development of affect management skills. The MM protocol will be based on Cognitive Behavioral Analysis System of Psychotherapy (CBASP), a psychotherapy developed for the treatment of chronic depression that has been shown to be highly effective in reducing depression in this difficult-to-treat population. HE participants will receive an additional 50 minutes of standard pre/postnatal health education focused on non-smoking related issues relevant to maintaining a healthy pregnancy. The UC condition will receive 7 3 to 5-minute Clinical Guidelines-based brief counseling sessions that will be similar in content to the smoking cessation counseling component of the MM and HE interventions. We hypothesize that cessation rates during pregnancy and at 3 and 6 months postpartum will be significantly greater for smokers in the MM versus the HE and UC control conditions. In addition, we hypothesize that smokers with significant levels of depression and/or positive histories of depression at the start of the intervention will quit significantly less often than nondepressed smokers and negative depression history smokers. We will also evaluate the role of coping, self-efficacy, social support, perceived counselor support, perceived stress, negative affect, and depression as mediators of treatment outcome. As secondary aims we will assess whether levels of depression are significantly reduced for smokers in the MM condition relative to those in the HE or UC conditions, and we will assess the role of neuroticism in the relationship between depression and nicotine dependence. We will also evaluate the extent of smoking reduction (cigarettes smoked/cotinine) among women who fail to quit, as a function of treatment, depression history, and current depression.
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