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. 资助概要 尽管拉丁裔是美国人口规模最大、增长最快的群体之一，但 人们经历着显着的健康差异，特别是在危险饮酒和同时发生的情况方面 临床焦虑。迄今为止，还没有针对临床焦虑背景下的危险饮酒的干预措施 在拉丁裔人群中。目前的 R01 提案以我们过去的工作为基础，制定了一个简短的、单一的 基于计算机的个性化反馈干预 (PFI) 旨在增强有关以下方面的知识： 不良焦虑与酒精的相互关系，增加减少危险饮酒的动机和意图，以及 减少关于使用酒精缓解焦虑的积极态度和意图。 具体来说，我们建议为拉丁裔开发一种低成本、高度传播的综合 PFI 患有临床焦虑症的危险饮酒者（AA-PFI 1.0），将在以下方面实施并测试其有效性 以社区为基础的卫生诊所。我们的方法将遵循与美国国家研究院一致的分阶段模型 制定和标准化行为干预措施的健康 (NIH) 指南。 IA 阶段活动将 涉及从三个迭代焦点小组 (N = 21) 收集定性和定量反馈以进行改进 干预内容并评估治疗的可接受性和可行性。 IB 阶段活动将包括 严格的随机临床试验，旨在比较 AA-PFI 2.0 与对照 PFI (C-PFI) 的有效性 在 250 名患有临床焦虑症的拉丁裔危险饮酒者样本中，他们在社区内接受护理—— 为基础的健康诊所。这项研究代表了翻译领域的重要且关键的一步 基础研究以制定更有效的策略，以减少服务不足人群的危险饮酒 生物行为合并症。拟议的研究项目支持2017-2021年战略计划 国家酒精滥用和酒精中毒研究所 (NIAAA) 推进两个关键领域的研究。 首先，当前提案的最终目标是改进防止酒精滥用、饮酒的策略 疾病，以及这些疾病的“高危”人群中与酒精相关的后果（目标 3）。 其次，它通过关注最快的研究之一，增强了 NIAAA 支持的研究对公众健康的影响。 美国人口数量不断增长且规模最大，他们在危险饮酒方面表现出差异（目标 5）。这 当前的申请与 RFA-AA-21-001 的目标一致，建议检查低的有效性 成本低、可高度传播、个性化、文化适应的 PFI，针对拉丁裔危险饮酒者，并经过临床 社区卫生诊所内的焦虑。考虑到并发焦虑对公共健康的集体影响 和酒精使用，我们相信拟议的研究将产生增强科学知识、推进 我们对焦虑与酒精使用关系机制的理解，并为新颖的开发提供信息 针对患有临床焦虑症的危险饮酒者的治疗方法具有适应性并且易于在整个国家实施 各种医疗保健环境。拟议的补充将扩大对有效性的审查 通过探索文化定制的 PFI 对福祉不同方面的影响进行干预，以及如何 干预后幸福感的变化与焦虑和饮酒的变化有关。这 博士之前已经发现了幸福的结果。 Zvolensky 和 ​​Gallagher 预测弹性和 从焦虑/酒精后果中恢复，因此家长补助金的这一附加部分将增强我们的 了解干预措施的潜在持久影响，同时提供量身定制的培训体验 献给森格女士。关于她的培训计划，Senger 女士将由 Drs. 共同指导。兹沃连斯基和加拉格尔 通过定期会议和监督，提供支持 Senger 女士所需的理想专业知识组合 在她作为一名科学家的发展过程中。第一年，Senger 女士将有机会协助创办一家 随机对照试验、撰写受邀文章并出席会议。第二年，她将 有机会学习更复杂的分析，例如结构方程建模，共同作者 实证文章，并在会议上传播她的发现。第三年，Senger 女士将协助 干预保留、学习多层次建模并制定国家研究服务奖 (NRSA) 提议。 目标 1. IA 阶段：制定适合文化的、单次、集成、基于计算机的简报 酒精焦虑 PFI (AA-PFI 1.0) 旨在 (1) 增强对不良酒精焦虑的了解 相互关系； (2) 增强减少危险饮酒的动力和意愿； (3)减少积极 关于饮酒的态度和意图。此阶段将重点关注开发和迭代 使用从三个焦点小组收集的定性和定量数据来完善 AA-PFI 1.0 来自内部和外部专家顾问的反馈。我们将确定治疗实施的可行性、参与者 患有共病临床焦虑的危险饮酒者的可接受性和潜在影响（N = 21）。 目标 2. IB 期：进行随机对照试验，测试 AA-PFI 2.0（与 C- PFI）关于减少饮酒的动机/意图、通过饮酒管理焦虑的期望，以及 患有临床焦虑的拉丁裔危险饮酒者对饮酒的态度/意图 (N = 250) PHS 398/2590（修订版。09/04，重新发布 4/2006）第 2 页 首席研究员/项目总监（最后、第一、中间）：Zvolensky, Michael J. 在社区卫生诊所内。 假设：在测试后，随机分配到 AA-PFI 2.0（相对于 C-PFI）的参与者将报告： H1A：将饮酒减少到无害水平的更大动机/意图 H1B：减少饮酒以减轻/应对焦虑的期望 H1C：减少对饮酒的适应不良态度/意图 假设：在 1、3 和 6 个月的随访中，随机分配至 AA-PFI 2.0（相对于 C-PFI）的参与者将表现出： H2A：从危险饮酒到无害饮酒的比率变化较大，饮酒比率较低 消费（例如过去一个月饮酒）以及与酒精相关的负面后果 H2b：焦虑症状减轻以及焦虑症状造成的损害 探索性目标 3. 探索动机 (H1A)、期望 (H1B) 和态度/意图的变化 (H1C) 作为 1-3 个月和 6 个月随访结果的中介。 H3A：AA-PFI 2.0（相对于 C-PFI）对 1、3 和 6 个月随访结果的影响将由 以下测试后结果：（1）减少饮酒的动机/意图，（2）对焦虑的预期 通过饮酒应对/减少，以及 (3) 关于饮酒的态度/意图（针对 H2A 和 H2b）。 探索性目标 4. 探索 AA-PFI 2.0 与 C-PFI 效应的调节因素。 H4A：AA-PFI 2.0（与 C-PFI）对测试后以及 1、3 和 6 个月随访结果的影响将是 女性（相对于男性）参与者和持有更强 simpatía 价值观的拉丁裔人群中比例更大。 AA-PFI 2.0（相对于 C-PFI）对测试后以及 1、3 和 6 个月随访结果的影响会更小 针对那些基线感知种族歧视程度较高且对 COVID-19 基线担忧程度较高的人。