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

患有临床焦虑的拉丁裔危险饮酒者：个性化规范反馈干预的有效性试验

• 批准号: 10616033
• 负责人: MICHAEL J. ZVOLENSKY
• 金额: $ 4.32万
• 依托单位: UNIVERSITY OF HOUSTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10616033
• 关键词: Address; Alcohol consumption; Alcohols; Anxiety; Area; Attitude; Basic Science; Behavior Therapy; Behavioral Medicine; COVID-19; Caring; Clinic; Clinical Trials Design; Community Health; Complex Analysis; Computers; Data; Development; Effectiveness; Effectiveness of Interventions; Equation; Expectancy; Feedback; Female; Focus Groups; Funding; Funding Opportunities; Goals; Grant; Guidelines; Happiness; Health Promotion; Impairment; Intention; Intervention; Knowledge; Latinx; Latinx population; Learning; Mediating; Mediator of activation protein; Mentors; Mexican Americans; Modeling; Motivation; National Institute on Alcohol Abuse and Alcoholism; National Research Service Awards; Outcome; Participant; Personal Satisfaction; Phase; Populations at Risk; Principal Investigator; Public Health; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recovery; Reporting; Research; Research Project Grants; Research Support; Sampling; Scientist; Standardization; Strategic Planning; Supervision; Testing; Training; Translating; Underserved Population; United States; United States National Institutes of Health; Woman; Work; acceptability and feasibility; alcohol misuse; alcohol misuse prevention; alcohol related consequences; alcohol use disorder; anxiety management; anxiety symptoms; base; biobehavior; clinical anxiety; comorbidity; compare effectiveness; coping; cost; demographics; design; drinking; effectiveness testing; effectiveness trial; ethnic discrimination; experience; follow-up; hazardous drinking; health care settings; health disparity; improved; innovation; interest; intervention effect; male; meetings; multilevel analysis; novel; parent grant; personalized normative feedback; professor; programs; public health priorities; public health research; resilience; symposium; therapy design; therapy development

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.

1。资助赠款的摘要 尽管是美国（美国）的最大，增长最快的人口统计学之一，但拉丁裔 人们经历了严重的健康差异，特别是在危险饮酒和同时发生方面 临床动画。迄今为止，在临床动画的背景下，迄今为止尚无干预措施。 在拉丁人中。当前的R01提案是在我们过去的工作基础上建立的，这是通过开发简短的，单一的 会议，基于计算机的个性化反馈干预（PFI），旨在增强有关的知识 不良焦虑与酒精相互关系，增加动力和减少危险饮酒的意图， 减少关于使用酒精进行动画的积极出勤率和意图。 具体而言，我们建议为Latinx开发低成本，高度散布的综合PFI 临床动画（AA-PFI 1.0）的危险饮酒者将在实施和测试中的有效性 基于社区的健康诊所。我们的方法将遵循与国家机构一致的分阶段模型 健康（NIH）制定和标准化行为干预措施的指南。 IA期活动将 涉及从三个迭代焦点组（n = 21）收集定性和定量反馈以完善 干预内容和评估治疗可接受性和可行性。 IB期活动将包括 严格的随机临床试验旨在比较AA-PFI 2.0与对照PFI的有效性（C-PFI） 在有250名拉丁语危险饮酒者的样本中，他们在社区内得到护理的临床动画 - 基于健康诊所。这项研究代表了翻译更大的景观中重要而关键的步骤 基础研究，以减少服务不足的人群的危险饮酒的更有效策略 生物行为合并症。拟议的研究项目支持2017 - 2021年的战略计划 国家酒精滥用和酒精中毒研究所（NIAAA）通过在两个关键领域进行研究。 首先，当前的提案的最终目标是改善防止滥用酒精的策略 对于这些条件，疾病和酒精相关的后果（目标3）。 其次，它通过专注于最快的研究之一，从而增强了NIAAA支持研究的公共卫生影响 在美国增长，最大的人口统计数据，表现出危险饮酒中的分布（目标5）。 当前的应用程序与RFA-AA-21-001的目标保持一致。 成本，高度散布，个性化的，文化化适用于拉丁裔有害饮酒者的PFI 社区卫生诊所内的焦虑。鉴于并发动画的集体公共卫生影响 我们认为，我们认为拟议的研究将产生增强科学知识，进步的发现 我们对动画和酒精使用关系中机制的理解，并告知新颖的发展 使用临床动画的危险饮酒者的治疗方法，这些动画具有适应性的，并且很容易实施 各种医疗机构。拟议的补充剂将扩大对 通过探索文化量身定制的PFI对福祉不同方面的影响以及如何进行干预，以及如何 福祉的变化与干预后的焦虑和酒精使用变化有关。 Drs以前已经发现了福祉结果。 Zvolensky和Gallagher预测对和 从焦虑/酒精结果中恢复 在提供量身定制的培训经验的同时，了解干预措施的潜在持久影响 对于森格女士。关于她的培训计划，Senger女士将由Drs授予。 Zvolensky和Gallagher 通过定期会议和监督，提供支持Senger女士所需的理想专家 在她作为科学家的发展中。在第一年，森格女士将有机会协助开始 随机对照试验，作者邀请文章，并在会议上出席。在第二年，她将 有机会学习更多复杂的分析，例如结构方程建模，合着者 经验文章，并在会议上传播她的发现。在第三年，森格女士将协助 保留干预，学习多层次建模并开发国家研究服务奖（NRSA） 提议。 目标1。阶段IA：开发一种文化适应的简短，单会，集成，基于计算机的 动画 - 酒精PFI（AA-PFI 1.0）旨在（1）增强不良动画 - 酒精的知识 相互关系； （2）增加动力和减少危险饮酒的意图； （3）降低阳性 关于饮酒的态度和意图。这个阶段将重点放在发展和迭代上 使用从三个焦点组和 内部和外部专家顾问的反馈。我们将确定治疗交付的可行性，参与者 可接受性和合并症临床动画的危险饮酒者的潜在效果（n = 21）。 AIM 2。IB期：进行随机控制试验，以测试AA-PFI 2.0的有效性（相对于C- PFI）关于减少饮酒的动力/意图，通过饮酒对动画管理的期望以及 与临床动画的拉丁危险饮酒者中对酒精使用的态度/意图（n = 250） PHS 398/2590（修订版09/04，重新发行4/2006）第2页 首席研究员/计划主管（最后，第一，中间）：Zvolensky，Michael J. 在社区的健康诊所内。 假设：在后测试中，参与者随机分配给AA-PFI 2.0（vs. C-PFI）：将报告： H1A：更大的动力/意图将饮酒降低到非危害水平 H1B：减少饮酒的期望减轻/应对动画 H1C：降低适应性的出勤/意图 假设：在1-、3和6个月的随访中，参与者随机分为AA-PFI 2.0（对C-PFI）将证明： H2A：从危险到非危害饮酒的速率变化更大程度 消费（例如，过去一个月的饮料）和与酒精有关的负面后果 H2B：动画符号减少的动画符号和障碍 探索目的3。探索动机（H1A），期望（H1B）和出席/意图的变化 （H1C）作为1-3和6个月的随访结果的介体。 H3A：AA-PFI 2.0（相对于C-PFI）对1，3-和6个月的随访结果的影响将由该结果介导 遵循测试后的结果：（1）减少饮酒的动机/意图，（2）对动画的期望 - 通过饮酒进行应对/减少，（3）参加有关酒精使用的/意图（对于H2A和H2B）。 探索目的4。探索AA-PFI 2.0与C-PFI效应的主持人。 H4A：AA-PFI 2.0（vs. C-PFI）对测试后以及1-、3-和6个月的随访结果的影响将是 在女性（相对于男性）参与者和拉丁人中，拥有强大价值观的女性中较大。 AA-PFI 2.0（vs. C-PFI）对测试后以及1-、3-和6个月的随访结果的影响将较小 对于那些基线感知到种族歧视和更大的基线covid-19的担忧的人。