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.

抽象的 酒精使用障碍（AUD）和急性中毒对亲密伴侣暴力具有显着的精度影响 （IPV）。相反，IPV对AUD治疗产生负面影响并增加了缓解风险。尽管强烈 关于此联系潜在的行为机制的科学探究，仍然需要至关重要的需要 确定复杂的多模式机制并开发有效的治疗方法，以减少饮酒的IPV。 以呼吸窦性心律不齐的形式缓解适应不良的生理反应性。 可变性（HRV）是实现这一目标的一种承诺途径。 HRV是同情的自主生物标志物 与听觉病理生理学相关的主导和情绪过度。我们团队的诺言实验室 研究还表明，HRV是涉及酒精采用IPV的新兴机制。但是， 实现临床翻译的关键步骤是将这些发现扩展到自然主义环境。主要 拟议项目的目的是使用可穿戴技术来开发HRV的概念证明 体内酒精采用IPV的生物标志物。我们的次要目标是检查初步可用性， 可行性和遥远，自我管理的HRV生物反馈（HRV-B）干预的可接受性。到 这样做，我们将在28天的创新中利用谨慎，低成本的可穿戴技术 微型态设计。参与者（n = 50对夫妻，100位参与者）将完成生态 瞬时评估（EMA；每天4次，加上可选的事件触发报告），夫妇 包括IPV在内的冲突，并通过智能手机影响。每个二元组中的两个合作伙伴将分配给 相同的评估时间表，我们将使用地理位置来进一步将我们的主要结果背景。 在第21-28天，参与者还将收到每天一次的提示，以完成10分钟的HRV-B 非随机，开放标签的方法。这项研究还将利用我们团队已建立的远程 正在进行的AUD试验的参与程序。参与者将可以选择完成研究 远程使用电子知情同意，邮寄研究材料和访谈，调查和直接调查 使用符合HIPAA的平台观察生物样品数据。这些发现将用于 优化并优化我们的方法论，统计能力以及HRV-B剂量和时机，以准备 协作R01申请提案提案的HRV-B效率随机对照试验已交付 以“及时”的方式进行远程远程。拟议的研究直接解决了国家研究所的任务 关于酒精滥用和酒精中毒（NIAAA），这将确定实时生理和行为 自然主义环境中酒精采用的IPV的先例和后遗症。我们的发现将提供 关键的新信息，以推进机械科学并加速临床预防和 与酒精相关的IPV领域的干预工作是紧急的国家健康重点。