Using Wearable Technology to Develop Biomarker-Driven Intervention for Alcohol-Facilitated Intimate Partner Violence

使用可穿戴技术开发生物标记驱动的干预措施，以应对酒精引发的亲密伴侣暴力

• 批准号: 10577750
• 负责人: JULIANNE Christina Flanagan
• 金额: $ 18.23万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2024-06-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10577750
• 关键词: Acceleration; Accelerometer; Acute; Address; Adult; Affect; Alcohol consumption; Alcoholic Intoxication; Alcohols; Area; Arousal; Behavior; Behavior Therapy; Behavioral; Behavioral Mechanisms; Biofeedback; Biological; Biological Markers; Cellular Phone; Clinical; Cognition; Complex; Conflict (Psychology); Couples; Data; Development; Distress; Dose; Dropout; Ecological momentary assessment; Electronics; Emotional; Emotions; Enrollment; Event; Feedback; Financial Hardship; Functional disorder; Funding; Goals; Health; Health Insurance Portability and Accountability Act; Health Priorities; Heart Rate; Informed Consent; Intervention; Interview; Intoxication; Laboratories; Laboratory Finding; Laboratory Research; Laboratory Study; Link; Literature; Longitudinal Studies; Malignant - descriptor; Measures; Methodology; Mission; Morbidity - disease rate; Muscle relaxation phase; National Institute on Alcohol Abuse and Alcoholism; Participant; Pathway interactions; Patient Self-Report; Patients; Physiologic Monitoring; Physiological; Pilot Projects; Preparation; Prevention; Procedures; Public Health; Randomized; Randomized, Controlled Trials; Readiness; Recovery; Reporting; Role; Sampling; Schedule; Science; Scientific Inquiry; Self Administration; Series; Sinus Arrhythmia; Stimulus; Surveys; Symptoms; Time; Translating; Treatment outcome; Violence; Woman; alcohol effect; alcohol intervention; alcohol use disorder; behavioral outcome; biological adaptation to stress; biomarker driven; clinical translation; comparison control; cost; craving; design; effective therapy; efficacy testing; efficacy trial; emotional distress; experience; heart rate variability; high risk behavior; improved; in vivo; innovation; intimate partner violence; longitudinal design; men; mortality risk; multimodality; novel; open label; personalized intervention; primary outcome; public health priorities; reduced alcohol use; relapse risk; remote delivery; respiratory; smartphone application; translational study; usability; wearable device

ABSTRACT Alcohol use disorder (AUD) and acute intoxication have a salient precipitous effect on intimate partner violence (IPV). Conversely, IPV negatively impacts AUD treatment and increases risk for relapse. Despite intense scientific inquiry regarding behavioral mechanisms underlying this link, there remains a critical unmet need to identify complex multimodal mechanisms and develop effective treatments to reduce alcohol-facilitated IPV. Mitigating maladaptive physiological reactivity in the form of respiratory sinus arrhythmia measure of heart rate variability (HRV) is one promising pathway to achieve this goal. HRV is an autonomic biomarker of sympathetic dominance and emotional over-arousal relevant to AUD pathophysiology. Our team’s promising laboratory research also suggests that HRV is an emerging mechanism underlying alcohol-facilitated IPV. However, a critical step to achieve clinical translation is to extend these findings to naturalistic settings. The primary objective of the proposed project is to use wearable technology to develop proof-of-concept of HRV as a biomarker of alcohol-facilitated IPV in vivo. Our secondary objective is to examine the preliminary usability, feasibility, and acceptability of a remote, self-administered HRV biofeedback (HRV-B) intervention. To accomplish this, we will utilize discreet, low cost wearable technology in an innovative 28-day micro-longitudinal design. Participants (N=50 couples, 100 total participants) will complete ecological momentary assessment (EMA; 4 times daily plus optional event-triggered reports) of alcohol use, couple conflict including IPV, and affect via smartphone. Both partners within each dyad will be assigned to the same assessment schedule, and we will use geolocation to further contextualize our primary outcomes. During days 21-28, participants will also receive once-daily prompts to complete 10 minutes of HRV-B in a non-randomized, open-label approach. This study will also leverage our team’s established remote participation procedures from ongoing AUD trials. Participants will have the option to complete the study remotely using electronic informed consent, mailing of study materials, and interviews, surveys, and direct observation of biologic sample data using HIPAA-compliant platforms. These findings will be used to refine and optimize our methodology, statistical power, and HRV-B dose and timing in preparation for a collaborative R01 application proposing a randomized controlled trial of the efficacy of HRV-B delivered remotely in a “just-in-time” fashion. The proposed study directly addresses the mission of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in that will identify real-time physiological and behavioral antecedents and sequelae of alcohol-facilitated IPV in naturalistic settings. Our findings will provide critical new information to advance the mechanistic science and accelerate clinical prevention and intervention efforts in the area of alcohol-related IPV, which is an urgent national health priority.

摘要 酒精使用障碍（AUD）和急性中毒对亲密伴侣暴力有显著的影响 （IPV）。相反，IPV对AUD治疗产生负面影响，并增加复发风险。尽管激烈 关于这种联系背后的行为机制的科学调查，仍然存在一个关键的未满足的需求， 确定复杂的多模式机制，并开发有效的治疗方法，以减少酒精促进的IPV。 缓解呼吸性窦性心律失常形式的适应不良生理反应 心率变异性（HRV）是实现这一目标的一种有希望的途径。HRV是交感神经系统的自主生物标志物， 与AUD病理生理学相关的支配和情绪过度觉醒。我们团队很有前途的实验室 研究还表明，心率变异性是一种新兴的机制，潜在的酒精促进IPV。但 实现临床转化的关键步骤是将这些发现扩展到自然环境。主 拟议项目的目标是使用可穿戴技术开发HRV的概念验证， 体内酒精促进的IPV的生物标志物。我们的第二个目标是检查初步的可用性， 远程自我管理的HRV生物反馈（HRV-B）干预的可行性和可接受性。到 为了实现这一目标，我们将在28天内利用谨慎、低成本的可穿戴技术， 微纵向设计参与者（N=50对夫妇，共100名参与者）将完成生态 酒精使用的瞬时评估（EMA;每日4次+可选的事件触发报告），夫妇 冲突，包括IPV，并通过智能手机影响。每对中的两个伙伴将被分配到 同样的评估时间表，我们将使用地理定位来进一步将我们的主要结果置于背景中。 在第21-28天期间，参与者还将收到每天一次的提示，要求他们在一天内完成10分钟的HRV-B。 非随机、开放标签方法。这项研究还将利用我们团队建立的远程 正在进行的AUD试验的参与程序。参与者可以选择是否完成研究 远程使用电子知情同意书，邮寄研究材料，以及访谈，调查和直接 使用符合HIPAA的平台观察生物样品数据。这些发现将用于 完善和优化我们的方法学、统计功效、HRV-B剂量和时间， 合作R 01申请，提出一项HRV-B有效性的随机对照试验 以“即时”方式远程地进行。拟议的研究直接涉及国家研究所的使命 酒精滥用和酒精中毒（NIAAA），将确定实时生理和行为 自然环境中酒精促进IPV的前因和后遗症。我们的发现将提供 重要的新信息，以推进机械科学和加速临床预防， 在与酒精有关的IPV领域开展干预工作，这是一个紧迫的国家卫生优先事项。