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.”

项目摘要 背景性少数女性是危险饮酒的高危人群之一 (HD)和共病的心理健康问题（例如，抑郁症，焦虑症），因为他们接触少数民族 应激源（即，与耻辱有关的负担）和相关的压力反应，如喝酒来科普。研究 识别的认知（例如，拒绝的期望），情感的（例如，羞耻），和行为（例如，回避型 少数族裔压力使法定最低工资面临不成比例的HD和共病风险的途径 抑郁/焦虑。然而，没有干预措施解决这些途径。事实上，没有HD干预过 测试SMW的功效。初步研究。通过深入的利益相关者投入和NIH（R 01 MH 109413- 02 S1）和基金会（女同性恋健康基金）的支持下，我们创建了EQuIP（增强同性恋身份， 心理治疗）。EQuIP是一个10节的认知行为干预，专注于改善法定最低工资的少数群体 通过提高对少数民族压力危害的认识，建立自我肯定的认知方式， 减少逃避应对。在一项等待名单对照的中试试验（n=60）中，EQuIP显示出很强的前景， 通过建立对少数民族压力的适应性反应来减少HD和抑郁/焦虑，使其成为第一个 对改善这一人群同时发生的行为和心理健康的干预具有初步效果 挑战方法.我们现在试图测试EQuIP的有效性，并确定扩大规模的促进因素。 有希望的干预。目的1：在一项SMW的2组随机对照试验（RCT）中， 共病抑郁和/或焦虑，我们将测试EQuIP（n=225）对常规治疗（即， 支持性咨询）（n=225）。我们的主要结果是30岁以下的重度饮酒天数（≥4杯）的比例， 日时间轴跟踪。次要结果包括世卫组织酒精风险水平和抑郁症的降低， 焦虑由于远程干预交付已迅速成为规范，无论是EQuIP和治疗， 通常将通过远程医疗（Zoom）提供。事实上，我们的EQuIP第二个试点发现了很强的可行性， 远程保健服务的可接受性。目标2：基线、4、8和12个月时的评估将确定是否 减少EQuIP的预期心理社会机制（例如，内化的耻辱感，拒绝敏感性， 情绪失调）介导大量饮酒的减少。为了推进个性化医疗，我们还将 检查EQuIP是否在关键人口统计学因素和污名调节因素中具有差异有效性。 目标3：为准备在前线环境中实施，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）、供应商（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EQuIP实施的促进者 在这些中心。摘要作为SMW的HD和共同发生的心理健康干预的第一个试验， 这项研究响应了NIAAA的呼吁，即进行“解决AUDs和相关问题的干预措施， 符合性和性别少数群体的需要。”