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

项目总结/摘要 创伤后应激障碍（PTSD）是一种使人衰弱的疾病，影响着数百万美国退伍军人 和平民延长暴露（PE）治疗是循证且有效的，但受高脱落率的限制 约三分之一的患者症状不完全缓解。作为PE的重要组成部分， 以及焦虑症的干预措施，是“体内暴露”（IVE），在此期间，患者接近安全，但 避免“真实的世界”中的刺激。通常，患者被给予体内分配，以完成介于 治疗疗程，这使得提供者依赖于患者的自我报告，并可能增加患者的风险 脱离接触和辍学。目前，还没有针对IVE的数字技术系统。拟议 一项研究通过使用智能生物识别技术（IB）来个性化和优化IVE，直接解决了这一关键差距。的 一个新的系统（IB-PE）包括一个多维数据采集和存储系统，以捕获实时 接合的生物标志物（例如，心率、皮肤电导）和自我报告（例如，主观痛苦单位 或SUDS），使治疗师能够在伊韦斯期间虚拟陪伴患者（无需离开办公室） 并根据激活的客观生物特征来修改练习，以确保最大效率， 治疗益处，从而消除标准PE的传统缺点。此外，该系统将 记录伊韦斯用于离线分析。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伊韦斯， 患者参与不足或过度，并受益于离线审查伊韦斯以指导治疗 规划该第1阶段项目将：（1）将生理生物标志物传感器与SUDS和音频/视频集成 （2）决定是否可行及可接受， 评估新系统在实际环境中的易用性、舒适度和实用性;以及（3）进行 12-在40名患有PTSD的退伍军人中进行了一项随机临床试验，以评估IB-PE在治疗PTSD中的初步疗效。 从基线到第12次治疗降低了PTSD的严重程度。此外，亦会分析录得的个别教育课程， 确定具有较高治疗反应预测价值的生物和行为指标。结束时 在这个项目中，一个舒适和不显眼的系统将准备用于IB-PE的更大的确定性试验。是 预计IB-PE系统将通过技术支持的人力支持和指导， 显著减少创伤后应激障碍的症状实现较少的会议，从而降低成本和改善 access.本申请直接响应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。这项研究的结果表明， 创新和改变临床实践的潜力，并显着改善创伤后应激障碍的暴露疗法。

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.