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: 10083277
• 负责人: SUDIE E BACK
• 金额: $ 5.5万
• 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 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10083277
• 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）是一种令人衰弱的疾病，影响了数百万美国退伍军人 和平民。长时间暴露（PE）治疗是基于证据且有效的，但受到高辍学率的限制 大约三分之一的患者的症状分辨率不完全。 PE的关键组成部分 以及焦虑症的干预措施是“体内暴露”（IVE），在此期间，患者安全地接近但 在“现实世界”中避免了刺激。通常，将患者在体内分配中进行完成 治疗课程使提供者对患者自我报告负责，并可能增加患者的风险 脱离接触和辍学。目前，没有针对IVE的数字技术系统。提议 研究直接通过使用智能生物识别技术（IB）来个性化和优化IVE来直接解决这一关键差距。这 新系统（IB-PE）包括一个多维数据采集和存储系统，以捕获实时 参与的生物标志物（例如，心率，皮肤电导）和自我报告（例如，遇险主题单位 或在IVES期间），使治疗师能够在IVES期间几乎容纳患者（而无需离开办公室） 并基于客观的激活生物识别方法来修改练习，以确保最高效率和 治疗益处，从而消除了标准PE的传统缺点。此外，系统将 记录IVE的离线分析。关键的创新是，克林尼克人将能够第一次 参与办公室的IVE经验，使用实时生物识别技术来优化IVE并最小化 患者不足或过度参与，并有利于审查Ives离线指导治疗 规划。该阶段1项目将：（1）将物理生物标志物传感器与泡沫和音频/视觉 流入IVE期间的基于办公室的治疗师的系统； （2）确定可行性和可接受性 通过在现实世界中衡量易用性，舒适性和实用性来衡量新系统； （3）进行 40名具有PTSD的退伍军人的12条经合随机临床试验，以评估IB-PE的初步效率 从基线到第12节降低PTSD的严重性。此外，将分析记录的IVE会议 确定具有高预测值的生物学和行为指标。结论 在这个项目中，一个舒适且不引人注目的系统将准备好进行IB-PE的更大权威试验。这是 预计IB-PE系统将通过支持技术的人力支持和指导，从而在临床上导致 通过更少的会议减少了PTSD症状的大幅减少，从而降低了成本并提高 使用权。该申请直接响应FOA（PA-18-579），鼓励STTR赠款申请到 支持优先研究主题的研究和开发 - 需要资金水平的复杂技术 以及超出标准STTR指南中反映的持续时间。这项研究的发现有 具有创新和改变临床实践的潜力，并显着改善了PTSD的暴露疗法。