This is a first revision of application 1 R01 AA017163-01, """"""""Testing CBT Models and Change Mechanisms for Alcohol Dependent Women,"""""""" originally submitted 02/07. The overall goal of the proposed research is to develop empirically supported and cost-effective models of treatment for women with alcohol use disorders. The proposed research will address three gaps in the scientific literature and clinical options for treatment of alcohol problems, including a. limited research on and understanding of alcohol dependent women, b. limited understanding of what change mechanisms make alcohol treatment work to help patients reduce drinking and maintain sobriety, and c. a dearth of clinical research to develop and test cost-effective group therapy models for alcohol use disorders. The proposal is in response to PA-07-066, """"""""Alcohol Use Disorders: Treatment, Services Research, and Recovery,"""""""" and is consistent with several recent emphases within NIH, including community-friendly health services research (e.g., NIDA, 2002, 2003), underserved populations (i.e. women) (Longabaugh &Wirtz, 2001), and a focus on the mechanisms that underlie the process of change in therapy (NIAAA, 2006a). The study has 4 specific aims: (1) To modify our existing Individual Female Specific Cognitive Behavioral Therapy (I -FSCBT) approach to treat women with alcohol dependence in a group format (G- FSCBT);(2) To test the relative efficacy of Individual and Group FSCBT;and (3) To test hypothesized mechanisms of change in drinking that are common to both treatments, including (a) coping skills and enhanced self-efficacy for abstinence;(b) enhanced sense of autonomy;(c) alleviation of negative affect, and (d) increased social network support for abstinence, and (4) To assess the relative cost-effectiveness of the individual and group treatment. To accomplish these specific aims, 200 alcohol dependent women will be recruited via newspaper advertisement and community outreach to our outpatient clinic. The participants will complete baseline assessments, and then will be randomly assigned to 12 weekly outpatient manual- guided sessions of either Individual or Group FSCBT. Recruitment will span 37 months, over which we will run 16 therapy groups each comprised of 6 women, and also treat 100 individual cases. Both treatment conditions will be cognitive-behavioral in focus and adapted specifically for women. Both the group and individual treatments will be abstinence based, and include motivational enhancement, coping skills training, management of negative affect, skills to manage heavy drinkers in the social network, relapse prevention and themes related to autonomy. Participants will be assessed during treatment to track temporal changes in proposed mediator and outcome variables. Participants will complete in-person follow up assessments at 3, 9, and 15 months post-baseline, to assess maintenance of gains. The proposed clinical research is directly relevant to public health. Ultimately, availability of effective and affordable group therapy models to treat alcohol dependent women based on an understanding of how and why the therapy works, will enhance health delivery services and help reduce the personal and societal consequences of alcoholism. The overall goal of the proposed research is to develop empirically supported and cost-effective models of treatment for women with alcohol use disorders. The proposed research will address three gaps in the scientific literature and clinical options for treatment of alcohol problems, including a. limited research on and understanding of alcohol dependent women, b. limited understanding of what change mechanisms make alcohol treatment work to help patients reduce drinking and maintain sobriety, and c. a dearth of clinical research to develop and test cost-effective group therapy models for alcohol use disorders. The proposed clinical research is directly relevant to public health. Ultimately, availability of effective and affordable group therapy models to treat alcohol dependent women based on an understanding of how and why the therapy works, will enhance health delivery services and help reduce the personal and societal consequences of alcoholism.
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