Latinx Hazardous Drinkers with Clinical Anxiety: Effectiveness Trial of a Personalized Normative Feedback Intervention

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1. Summary of Funded Grant Despite being one of the largest and fastest-growing demographics in the United States (US), Latinx persons experience striking health disparities, particularly in terms of hazardous drinking and co-occurring clinical anxiety. No interventions to date have targeted hazardous drinking in the context of clinical anxiety among Latinx persons. The current R01 proposal builds upon our past work by developing a brief, single- session, computer-based, personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intentions regarding the use of alcohol for anxiety. Specifically, we propose to develop a low-cost, highly disseminatable, integrated PFI for Latinx hazardous drinkers with clinical anxiety (AA-PFI 1.0) that will be implemented and tested for effectiveness in community-based health clinics. Our approach will follow a staged model consistent with National Institutes of Health (NIH) guidelines for developing and standardizing behavioral interventions. Phase IA activities will involve collecting qualitative and quantitative feedback from three iterative focus groups (N = 21) to refine intervention content and evaluate treatment acceptability and feasibility. Phase IB activities will include a rigorous randomized clinical trial designed to compare the effectiveness of AA-PFI 2.0 to a control PFI (C-PFI) among a sample of 250 Latinx hazardous drinkers with clinical anxiety who receive care within community- based health clinics. This study represents an important and pivotal step in the larger landscape of translating basic research to more efficacious strategies for reducing hazardous drinking in underserved populations with biobehavioral comorbidities. The proposed research project supports the 2017-2021 strategic plan of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) by advancing research in two of the key areas. First, the current proposal has the end goal of improving strategies to prevent alcohol misuse, alcohol use disorder, and alcohol-related consequences among an ‘at-risk’ population for these conditions (goal 3). Second, it enhances the public health impact of NIAAA-supported research by focusing on one of the fastest- growing and largest demographics in the US who demonstrate disparities in hazardous drinking (goal 5). The current application aligns with the goals of RFA-AA-21-001 by proposing to examine the effectiveness of a low cost, highly disseminatable, personalized, culturally adapted PFI for Latinx hazardous drinkers with clinical anxiety within community-based health clinics. Given the collective public health impact of concurrent anxiety and alcohol use, we believe the proposed study will yield findings that enhance scientific knowledge, advance our understanding of mechanisms in anxiety-alcohol use relations, and inform the development of novel treatments for hazardous drinkers with clinical anxiety that are adaptable and easily implemented across a variety of healthcare settings. The proposed supplement will expand the examination of the effectiveness of the intervention by exploring the impact of the culturally tailored PFI on different facets of well-being, and how changes in well-being are associated with changes in anxiety and alcohol use following the intervention. The well-being outcomes have previously been found by Drs. Zvolensky and Gallagher to predict resilience to and recovery from anxiety/alcohol outcomes, so this added component to the parent grant will enhance our understanding of the potential lasting effects of the intervention while providing a tailored training experience for Ms. Senger. Regarding her training plan, Ms. Senger will be co-mentored by Drs. Zvolensky and Gallagher through regular meetings and supervision to provide the ideal blend of expertise needed to support Ms. Senger in her development as a scientist. In the first year, Ms. Senger will have the opportunity to assist in starting a randomized controlled trial, author an invited article, and present at a conference. In the second year, she will have the opportunity learn more complex analyses such as structural equation modeling, co-author an empirical article, and disseminate her findings at a conference. In the third year, Ms. Senger will assist with intervention retention, learn multi-level modeling, and develop a National Research Service Award (NRSA) proposal. Aim 1. Phase IA: Develop a culturally adapted brief, single-session, integrated, computer-based anxiety-alcohol PFI (AA-PFI 1.0) designed to (1) enhance knowledge of adverse anxiety-alcohol interrelations; (2) increase motivation and intention to reduce hazardous drinking; and (3) reduce positive attitudes and intention regarding alcohol use. This phase will focus on the development and iterative refinement of the AA-PFI 1.0, using qualitative and quantitative data collected from three focus groups and feedback from internal and external expert consultants. We will establish feasibility of treatment delivery, participant acceptability, and potential effect among hazardous drinkers with comorbid clinical anxiety (N = 21). Aim 2. Phase IB: Conduct a randomized-controlled trial testing the effectiveness of AA-PFI 2.0 (vs. C- PFI) on motivation/intention to reduce drinking, expectancies for anxiety management via drinking, and attitudes/intentions regarding alcohol use among Latinx hazardous drinkers with clinical anxiety (N = 250) PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Page 2 Principal Investigator/Program Director (Last, First, Middle): Zvolensky, Michael J. within community-based health clinics. Hypotheses: At post-test, participants randomized to AA-PFI 2.0 (vs. C-PFI) will report: H1A: greater motivation/intention to reduce drinking to non-hazardous levels H1B: reduced expectancies of drinking to mitigate/cope with anxiety H1C: reduced maladaptive attitudes/intentions regarding the use of alcohol Hypotheses: At 1-, 3-, and 6-month follow-up, participants randomized to AA-PFI 2.0 (vs. C-PFI) will evince: H2A: a greater degree of change in rates from hazardous to non-hazardous drinking, lower rates of alcohol consumption (e.g., drinks in the past month), and alcohol-related negative consequences H2b: reduced anxiety symptoms and impairment from anxiety symptoms Exploratory Aim 3. Explore change in motivation (H1A), expectancies (H1B), and attitudes/intentions (H1C) as mediators of 1-3- and 6-month follow-up outcomes. H3A: Effects of AA-PFI 2.0 (vs. C-PFI) on 1-, 3-, and 6-month follow-up outcomes will be mediated by the following post-test outcomes: (1) motivation/intention to reduce drinking, (2) expectancies for anxiety- coping/reduction via drinking, and (3) attitudes/intentions regarding alcohol use (for H2A and H2b). Exploratory Aim 4. Explore moderators of AA-PFI 2.0 vs. C-PFI effects. H4A: The effects of AA-PFI 2.0 (vs. C-PFI) on post-test and 1-, 3-, and 6-month follow-up outcomes will be larger among female (relative to male) participants and Latinx persons who hold stronger values of simpatía. The effects of AA-PFI 2.0 (vs. C-PFI) on post-test and 1-, 3-, and 6-month follow-up outcomes will be smaller for those with greater baseline perceived ethnic discrimination and greater baseline COVID-19 worry.