Using Wearable Technology to Develop Biomarker-Driven Intervention for Alcohol-Facilitated Intimate Partner Violence
Using Wearable Technology to Develop Biomarker-Driven Intervention for Alcohol-Facilitated Intimate Partner Violence
批准号:
10373267
负责人:
JULIANNE Christina Flanagan
金额:
$22.68万
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
已结题
起止时间:
2022-03-01 至 2024-02-28
关键词:
AccelerometerAcuteAddressAdultAffectAlcohol consumptionAlcoholic IntoxicationAlcoholsAreaArousalBehaviorBehavior TherapyBehavioralBehavioral MechanismsBiofeedbackBiologicalBiological MarkersCellular PhoneClinicalCognitionComplexConflict (Psychology)CouplesDataDevelopmentDistressDoseDropoutEcological momentary assessmentEmotionalEmotionsEnrollmentEventFeedbackFinancial HardshipFunctional disorderFundingGoalsHealthHealth Insurance Portability and Accountability ActHealth PrioritiesHeart RateInformed ConsentInterventionInterviewIntoxicationLaboratoriesLaboratory FindingLaboratory ResearchLaboratory StudyLinkLiteratureLongitudinal StudiesMalignant - descriptorMeasuresMethodologyMissionMorbidity - disease rateMuscle relaxation phaseNational Institute on Alcohol Abuse and AlcoholismParticipantPathway interactionsPatient Self-ReportPatientsPhysiologic MonitoringPhysiologicalPilot ProjectsPreparationPreventionProceduresPublic HealthRandomizedRandomized Controlled TrialsReadinessRecoveryReportingRoleSamplingScheduleScienceScientific InquirySelf AdministrationSeriesSinus ArrhythmiaStimulusSurveysSymptomsTimeTranslatingTreatment outcomeViolenceWomanalcohol effectalcohol interventionalcohol use disorderbehavioral outcomebiological adaptation to stressbiomarker-drivenclinical translationcostcravingdesigneffective therapyefficacy testingefficacy trialemotional distressexperienceheart rate variabilityhigh risk behaviorimprovedin vivoinnovationintimate partner violencelongitudinal designmenmortality riskmultimodalitynovelopen labelpersonalized interventionprimary outcomepublic health prioritiesreduced alcohol userelapse riskremote deliveryrespiratorysmartphone Applicationtranslational studyusabilitywearable device
中文摘要
摘要
酒精使用障碍(AUD)和急性醉酒对亲密伴侣暴力有显著的急剧影响
(IPV)。相反,IPV对AUD治疗产生负面影响,并增加复发风险。尽管紧张
关于这种联系背后的行为机制的科学调查,仍然有一个关键的需求没有得到满足
确定复杂的多模式机制并开发有效的治疗方法来降低酒精促进的IPV。
减轻呼吸性窦性心律失常形式的适应不良生理反应性心率测量
变异性(HRV)是实现这一目标的一条很有希望的途径。心率变异性是交感神经的自主生物标志物
优势和情绪过度唤醒与AUD病理生理学相关。我们团队很有前途的实验室
研究还表明,HRV是酒精促进的IPV的一种新兴机制。然而,a
实现临床翻译的关键一步是将这些发现推广到自然环境中。初级阶段
拟议项目的目标是使用可穿戴技术来开发HRV的概念验证
酒精促进的IPV体内生物标志物。我们的次要目标是检查初步的可用性,
远程自我管理的心率变异性生物反馈(HRV-B)干预的可行性和可接受性。至
实现这一目标,我们将在创新的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;每天4次,外加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。每个二元组中的两个伙伴都将被分配到
同样的评估时间表,我们将使用地理位置来进一步了解我们的主要成果。
在第21-28天,参与者还将收到每天一次的提示,要求他们在一个月内完成10分钟的HRV-B
非随机化、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。参与者将有权选择完成研究
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标准的平台观察生物样本数据。这些发现将被用来
改进和优化我们的方法、统计能力以及HRV-B剂量和时机,为
协作性R01应用程序建议对HRV-B的有效性进行随机对照试验
以一种“及时”的方式远程运行。拟议的研究直接涉及国家研究所的任务
关于酒精滥用和酒精中毒(NIAAA)将实时识别生理和行为
自然主义环境下酒精促进型IPV的前驱和后遗症。我们的发现将提供
关键新信息促进机械科学发展,加速临床预防和治疗
与酒精有关的IPV领域的干预努力,这是一项紧迫的国家卫生优先事项。
英文摘要
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.
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