Intelligent Biometrics to Optimize Prolonged Exposure Treatment for PTSD (IB-PE)

智能生物识别技术优化 PTSD 长期暴露治疗 (IB-PE)

• 批准号: 10018114
• 负责人: SUDIE E BACK
• 金额: $ 44.73万
• 依托单位: ZERISCOPE, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-13 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10018114
• 关键词: Address; Affect; Affective; American; Anxiety Disorders; Applications Grants; Area; Behavioral; Biological; Biological Markers; Biometry; Businesses; Car Phone; Chronic; Clinical; Clinical Trials; Cognitive Therapy; Complex; Data; Data Analyses; Data Collection; Data Storage and Retrieval; Development; Disease; Distress; Dropout; Drops; Ensure; Environment; Equipment; Evidence based treatment; Exercise; Exposure to; Funding; Galvanic Skin Response; General Population; Guidelines; Health Expenditures; Health Technology; Healthcare; Heart Rate; Human; Improve Access; Intelligence; Intervention; Knowledge; Life; Logistics; Measures; Medical; Mental Health; Military Personnel; Mission; Monitor; Morphologic artifacts; National Institute of Mental Health; Outcome; Patient Self-Report; Patients; Perception; Phase; Physiological; Post-Traumatic Stress Disorders; Predictive Value; Protocols documentation; Provider; Public Health; Randomized Clinical Trials; Reporting; Research; Research Personnel; Research Priority; Research Support; Resolution; Risk; Science; Sensory; Services; Severities; Site; Small Business Technology Transfer Research; South Carolina; Stimulus; Strategic Planning; Stream; Symptoms; System; Technology; Testing; Therapeutic; Time; Universities; Veterans; Visual; base; biomarker-driven; clinical practice; clinically significant; cloud storage; cost; dashboard; data acquisition; digital; evidence base; experience; improved; in vivo; innovation; innovative technologies; insight; mobile computing; multidimensional data; multidisciplinary; novel; outcome prediction; patient engagement; premature; research and development; response; sensor; suicidal risk; treatment adherence; treatment planning; treatment response; usability; virtual

PROJECT SUMMARY/ABSTRACT Posttraumatic Stress Disorder (PTSD) is a debilitating disease affecting millions of American military veterans and civilians. Prolonged Exposure (PE) therapy is evidence-based and effective but limited by high dropout rates and incomplete resolution of symptoms in approximately one-third of patients. A crucial component of PE, as well as interventions for anxiety disorders, is “In Vivo Exposure” (IVE) during which patients approach safe but avoided stimuli in the “real world.” Typically, patients are given in vivo assignments to complete in-between therapy sessions, which leaves providers reliant upon patient self-report and may increase risk for patient disengagement and dropout. At present, there are no digital technology systems that target IVE. The proposed study directly addresses this critical gap by using intelligent biometrics (IB) to personalize and optimize IVE. The new system (IB-PE) includes a multidimensional data acquisition and storage system to capture real-time biomarkers of engagement (e.g., heart rate, skin conductance) and self-report (e.g., subjective units of distress or SUDS) during IVEs, enabling therapists to virtually accompany patients during IVEs (without leaving the office) and modify the exercises based on objective biometrics of activation to ensure maximal efficiency and therapeutic benefit, thereby eliminating traditional shortcomings of standard PE. Furthermore, the system will record IVEs for offline analysis. Key innovations are that—for the first time—clinicians will be able to participate in the IVE experience from the office, use real-time biometrics to optimize IVEs and minimize patient under- or over-engagement, and have the benefit of reviewing IVEs offline to guide treatment planning. This Phase 1 project will: (1) Integrate physiological biomarker sensors with SUDS and audio/visual streaming into a system for office-based therapists to use during IVE; (2) Determine feasibility and acceptability of the new system by measuring ease of use, comfort and utility in a real-world environment; and (3) Conduct a 12-session randomized clinical trial in 40 veterans with PTSD to evaluate preliminary efficacy of IB-PE in reducing PTSD severity from baseline to session 12. In addition, recorded IVE sessions will be analyzed to identify biological and behavioral indicators with high predictive value of treatment response. At the conclusion of this project, a comfortable and unobtrusive system will be ready for larger definitive trials of IB-PE. It is expected that the IB-PE system will, through technology-enabled human support and guidance, result in clinically significant reduction of PTSD symptoms achieved with fewer sessions, thereby lowering costs and improving access. This application is directly responsive to the FOA (PA-18-579) encouraging STTR grant applications to support research and development of priority research topics - complex technologies that require funding levels and durations beyond those reflected in the standard STTR guidelines. The findings from this study have the potential to innovate and transform clinical practice, and significantly improve exposure therapy for PTSD.

项目摘要/摘要 创伤后应激障碍(PTSD)是一种影响数百万美国退伍军人的衰弱疾病 和平民。长时间暴露(PE)疗法是一种循证有效的疗法，但存在高辍学率的局限性 约三分之一的患者症状解决不彻底。PE的一个重要组成部分，如 以及对焦虑症的干预，是“活体暴露”(IVE)，在此期间，患者接近安全但 避免在“真实世界”中受到刺激。通常情况下，患者被分配到体内完成中间任务 治疗课程，这使得提供者依赖于患者自我报告，并可能增加患者的风险 脱离和退学。目前，还没有针对IVE的数字技术系统。建议数 这项研究通过使用智能生物识别(IB)来个性化和优化IVE，直接解决了这一关键差距。这个 新系统(IB-PE)包括多维数据采集和存储系统，以捕获实时 参与度的生物标记物(例如心率、皮肤传导性)和自我报告(例如主观痛苦单位 或肥皂水)，使治疗师能够在Ives期间虚拟地陪伴患者(无需离开办公室) 并根据激活的客观生物特征修改练习，以确保最大效率和 有益于治疗，从而消除了标准PE的传统缺点。此外，该系统将 记录IVE以供离线分析。关键的创新是-第一次-临床医生将能够 从办公室参与IVE体验，使用实时生物识别技术优化IVE并最大限度地减少 患者参与度不足或过高，并受益于离线审查IVE以指导治疗 计划。该第一阶段项目将：(1)将生理生物标记物传感器与SODS和视听相结合 流入系统供办公室治疗师在IVE期间使用；(2)确定可行性和可接受性 通过测量实际环境中的易用性、舒适性和实用性来评估新系统；以及(3)进行 40例退伍军人创伤后应激障碍的12疗程随机临床试验评价IB-PE治疗PTSD的初步疗效 将创伤后应激障碍的严重程度从基线降低到第12次会议。此外，将分析录制的IVE会议以 确定对治疗反应具有较高预测价值的生物和行为指标。在结束时 在这个项目中，一个舒适和不显眼的系统将为IB-PE的更大规模的最终试验做好准备。它是 预计IB-PE系统将通过技术支持的人力支持和指导，在临床上 通过更少的疗程显著减少创伤后应激障碍症状，从而降低成本并改善 进入。这项申请直接响应FOA(PA-18-579)鼓励STTR赠款申请 支持优先研究课题的研究和开发--需要资金水平的复杂技术 以及超出标准STTR指南中所反映的持续时间。这项研究的发现具有 创新和改变临床实践的潜力，并显著改进创伤后应激障碍的暴露疗法。