A unified protocol to address sexual minority women's minority stress, mental health and hazardous drinking

解决性少数群体女性压力、心理健康和危险饮酒问题的统一协议

基本信息

批准号：
10703352
负责人：
TONDA L HUGHES
金额：
$ 74.95万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-12 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10703352
关键词：
2 arm randomized control trial Address Affect Affective Alcohol consumption Alcohol dependence Alcohols Anxiety Awareness Back Behavior Therapy Behavioral Bisexual Cardiovascular Diseases Cities Cognitive Cognitive Therapy Communities Coping Behavior Counseling County Demographic Factors Diagnostic Discrimination Disparity Eligibility Determination Ethnic Origin Exposure to Family Foundations Funding Gender Identity General Population Health Health Services Heavy Drinking Heterosexuals Incentives Individual Intervention Intervention Trial Interview Knowledge Laws Leadership Lesbian Lesbian Gay Bisexual Transgender Queer Link Liver diseases Malignant Neoplasms Mediating Mental Depression Mental Health Meta-Analysis Methods Modality Morbidity - disease rate Motivation National Institute on Alcohol Abuse and Alcoholism Participant Pathway interactions Persons Policies Population Populations at Risk Preparation Promoting Action on Research Implementation in Health Services framework Protocols documentation Provider Psychotherapy Race Randomized, Controlled Trials Reaction Reporting Research Risk Role Services Sex Orientation Sexual and Gender Minorities Shame Site Stress and Coping Structure System Testing Therapeutic Intervention Training United States National Institutes of Health Waiting Lists Woman Women&apos s Health World Health Organization acceptability and feasibility alcohol related problem alcohol risk alcohol use disorder assault behavioral health biological adaptation to stress community center community clinic community setting comorbid depression comorbidity coping disparity reduction drinking efficacy testing emotion dysregulation empowerment expectation experience gender minority group hazardous drinking help-seeking behavior high risk high risk population implementation facilitators improved internalized stigma intervention delivery laboratory experience men minority stress minority stressor mortality peer personalized medicine pilot trial primary outcome psychosocial queer remote delivery remote intervention response scale up secondary outcome sexual identity sexual minority women skills social stigma stress reduction telehealth timeline treatment as usual

项目摘要

PROJECT SUMMARY Background. Sexual minority women (SMW) represent one of the highest-risk groups for hazardous drinking (HD) and comorbid mental health problems (e.g., depression, anxiety) because of their exposure to minority stressors (i.e., stigma-related burdens) and associated stress reactions, like drinking to cope. Research has identified cognitive (e.g., expectations of rejection), affective (e.g., shame), and behavioral (e.g., avoidant coping) pathways through which minority stress places SMW at disproportionate risk of HD and comorbid depression/anxiety. Yet no interventions address these pathways. In fact, no HD intervention has ever been tested for efficacy with SMW. Preliminary Studies. With deep stakeholder input and NIH (R01MH109413- 02S1) and foundation (Lesbian Health Fund) support, we created EQuIP (Empowering Queer Identities in Psychotherapy). EQuIP is a 10-session cognitive-behavioral intervention focused on improving SMW’s minority stress reactions by raising awareness of the harms of minority stress, building self-affirming cognitive styles, and reducing avoidant coping. In a waitlist-controlled pilot trial (n=60), EQuIP showed strong promise for reducing HD and depression/anxiety by building adaptive responses to minority stress, making it the first intervention with preliminary efficacy for improving this population’s co-occurring behavioral and mental health challenges. Methods. We now seek to test EQuIP’s efficacy and identify facilitators of scale-up of this promising intervention. Aim 1: In a 2-arm randomized controlled trial (RCT) with SMW who experience HD and comorbid depression and/or anxiety, we will test the efficacy of EQuIP (n=225) against treatment-as-usual (i.e., supportive counseling) (n=225). Our primary outcome is proportion of heavy drinking days (≥4 drinks) on 30- day timeline followback. Secondary outcomes include reduction in WHO alcohol risk level and depression and anxiety. Because remote intervention delivery has quickly become normative, both EQuIP and treatment-as- usual will be delivered via telehealth (Zoom). In fact, our second pilot of EQuIP found strong feasibility and acceptability of telehealth delivery. Aim 2: Assessments at baseline, 4, 8, and 12 months will determine if reductions in EQuIP’s intended psychosocial mechanisms (e.g., internalized stigma, rejection sensitivity, emotion dysregulation) mediate heavy drinking reductions. To advance personalized medicine, we will also examine whether EQuIP is differentially efficacious across key demographic factors and stigma moderators. Aim 3: To prepare for implementation in frontline settings, we will conduct semi-structured interviews with directors (n=20), providers (n=20), and service users (n=20) from a network of 250 US LGBTQ community clinics. Applying the i-PARIHS framework will help identify facilitators that can support EQuIP implementation at these centers. Summary. As the first trial of an intervention for SMW’s HD and co-occurring mental health, this study responds to NIAAA’s call for trials of “interventions that address AUDs and related problems and that are appropriate to the needs of sexual and gender minority populations.”

项目概要背景：性少数女性（SMW）是危险饮酒的最高风险群体之一。（HD）和由于接触少数群体而导致的共病心理健康问题（例如抑郁、焦虑）研究发现，压力源（即与耻辱相关的负担）和相关的压力反应，例如通过饮酒来应对。识别认知（例如，拒绝的期望）、情感（例如，羞耻）和行为（例如，回避）应对）少数群体的压力使中小型工人面临不成比例的 HD 和共病风险然而，没有任何干预措施可以解决这些途径。经过 SMW 的初步研究和 NIH 的深入研究（R01MH109413-）。 02S1）和基金会（女同性恋健康基金）的支持下，我们创建了 EQuIP（Empowering Queer Identities in EQuIP 是一项为期 10 次的认知行为干预措施，重点是改善 SMW 的少数群体。通过提高对少数压力危害的认识、建立自我肯定的认知方式来缓解压力反应，在一项等待名单控制的试点试验（n = 60）中，EQuIP 显示出强烈的希望。通过对少数人的压力建立适应性反应来减少 HD 和抑郁/焦虑，使其成为第一个对改善该人群同时发生的行为和心理健康具有初步效果的干预措施我们现在寻求测试 EQuIP 的功效并确定扩大规模的促进因素。目标 1：在一项针对患有 HD 和 SMW 的 2 臂随机对照试验 (RCT) 中。共病抑郁和/或焦虑，我们将测试 EQuIP (n=225) 相对于常规治疗（即，支持性咨询）（n=225），我们的主要结果是 30-30 岁期间酗酒天数（≥4 杯）的比例。次要结果包括世卫组织酒精风险水平和抑郁症的降低。因为远程干预服务很快就成为常态，无论是 EQuIP 还是治疗。通常将通过远程医疗 (Zoom) 提供。事实上，我们的 EQuIP 的第二个试点发现了强大的可行性和可行性。目标 2：基线、4、8 和 12 个月的评估将确定是否可以接受远程医疗服务。减少 EQuIP 预期的心理社会机制（例如，内在的耻辱、拒绝敏感性、情绪失调）介导减少大量饮酒为了推进个性化医疗，我们还将检查 EQuIP 在关键人口因素和耻辱调节因素方面是否具有不同的功效。目标 3：为了准备在一线实施，我们将进行半结构化访谈来自 250 个美国 LGBTQ 社区网络的董事 (n=20)、提供者 (n=20) 和服务使用者 (n=20) 应用 i-PARIHS 框架将有助于确定可以支持 EQuIP 实施的促进者。作为对 SMW 的 HD 和同时发生的心理健康的干预的首次试验，这项研究响应了 NIAAA 的呼吁，即尝试“解决 AUD 和相关问题的干预措施，并且适合性少数群体的需求。”