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

• 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
• 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' 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

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.”

项目总结 背景资料。性少数群体妇女(SMW)是危险饮酒的高危群体之一 (HD)和共病的心理健康问题(例如，抑郁、焦虑)，因为他们接触少数族裔 压力源(即与耻辱相关的负担)和相关的压力反应，如饮酒来应对。研究表明， 确定的认知(例如，对拒绝的期望)、情感(例如，羞耻)和行为(例如，回避 应对)少数人应激使SMW处于HD和共病的不成比例风险的途径 抑郁/焦虑。然而，没有任何干预措施解决这些途径。事实上，从未有过高清干预 测试了SMW的有效性。初步研究。利益相关者深度投入和NIH(R01MH109413- 02S1)和基金会(女同性恋者健康基金)的支持下，我们创建了Equip(授权同性恋身份 心理治疗)。Equip是一项为期10个疗程的认知行为干预，专注于改善SMW的少数族裔 通过提高对少数族裔压力危害的认识，建立自我肯定的认知方式， 减少回避性应对。在等待名单控制的飞行员试验(n=60)中，Equip显示出强烈的希望 通过建立对少数族裔压力的适应性反应来减少HD和抑郁/焦虑，使其成为第一个 初步有效的干预措施改善这一人群的行为和心理健康 挑战。方法：研究方法。我们现在寻求测试EquipTM的有效性，并确定其扩展的促进者 承诺进行干预。目的1：在一项双臂随机对照试验(RCT)中，SMW患者经历HD和 同时患有抑郁和/或焦虑的患者，我们将测试Equp(n=225)与常规治疗(即， 支持性咨询)(n=225)。我们的主要结果是30-30天大量饮酒(≥4饮酒)的比例 一天的时间线跟在后面。次要结果包括世卫组织酒精风险水平和抑郁症的降低以及 焦虑。由于远程干预交付已迅速成为标准，设备和治疗都是如此 通常将通过远程医疗(Zoom)交付。事实上，我们的第二个装备试点发现了很强的可行性和 远程医疗服务的可接受性。目标2：基线、4个月、8个月和12个月的评估将确定是否 减少Equip预期的心理社会机制(例如，内在化耻辱、拒绝敏感性、 情绪失调)调节大量饮酒的减少。为了推进个性化医疗，我们还将 检查是否装备在关键的人口统计因素和污名调节因素之间具有不同的有效性。 目标3：为了准备在前线环境下实施，我们将与以下人员进行半结构化访谈 来自250个美国LGBTQ社区网络的董事(n=20)、提供商(n=20)和服务用户(n=20) 诊所。应用i-PARIHS框架将有助于确定能够支持装备实施的促进者 在这些中心。总结。作为对SMW的HD和共生心理健康干预的第一次试验， 这项研究响应了NIAAA的号召，要求进行试验，以解决AUDS和相关问题的干预措施， 适合性少数群体和性别少数群体的需求。