Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness

项目概要/摘要 该实验治疗剂R61/R33提案响应RFA-MH-18-704。这个项目的目标 是评估一种新的技术支持的混合干预，旨在减少社会孤立和改善 严重精神疾病的社会功能（SMI）。社会孤立在重度精神病患者中很常见，并导致发病率和 限制了功能恢复。不幸的是，很少有可用的干预措施专门针对社会孤立及其 SMI的决定因素，包括焦虑的社交回避，对互动的失败主义态度，以及社交 快感缺乏此外，这一领域的干预发展受到社会影响不精确测量的限制。 交互、过程和相关结构。我们新的混合干预，移动的社会互动疗法 由Exposure（mSITE）提供，将简短的面对面心理治疗与情境触发的移动的智能手机相结合 干预和远程电话辅导。mSITE建立在初步工作的基础上，表明混合移动的 干预是可以接受的，既加强又缩短了认知行为干预。最近的工作 我们的研究小组和其他人指出，环境，如在家或独自一人，加剧社会失败主义 对社会威胁的态度和看法。mSITE的独特之处在于它使用智能手机传感器（例如，GPS， 会话感测）以触发针对特定社交情境定制的干预内容 单独长时间或在社区中的社会互动后，为了认知和行为 在“正确的地点、正确的时间”采取干预措施。此外，该研究将首次审查 被动感知测量作为SMI临床试验的结局，通过推导阴性的客观数字标记， 使用智能手机传感器（GPS和麦克风）监测距离 旅行，在家里度过的时间，和谈话。在R61阶段，我们将招募具有SMI的人员， 有限的社会参与。然后，我们将对mSITE进行开放试验，评估干预是否 导致社会互动频率的临床显著变化（目标机制）。我们还将 通过在12评估变化， 18或24周。如果符合go/no go标准（社交互动中的中等效应量增加，< 20%）， 在R61阶段，R33阶段将包括一项随机试验，将mSITE与治疗师进行对比， 设备时间等效支持性接触（SC）条件。我们将评估mSITE是否会导致更大的 改善社会交往，阴性症状和社会功能相对于SC。我们还预测 社会互动的增加将介导体验性阴性症状和社会 功能我们的项目直接响应NIMH战略目标3.1，通过评估新的行为干预 通过验证新的数字生物标志物来客观测量社会功能改善， 流程.我们的项目还通过推进数字化， 评估和了解具体情况的移动的干预措施，这些措施的设计可扩展到社区环境。

PROJECT SUMMARY/ABSTRACT This experimental therapeutics R61/R33 proposal responds to RFA-MH-18-704. The goal of this project is to evaluate a new technology-supported blended intervention aimed at reducing social isolation and improving social functioning in serious mental illness (SMI). Social isolation is common in SMI and leads to morbidity and limits functional recovery. Unfortunately, few available interventions specifically target social isolation and its determinants in SMI, which include anxious social avoidance, defeatist attitudes toward interactions, and social anhedonia. Moreover, intervention development in this area is limited by imprecise measurement of social interactions, processes, and related constructs. Our new blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), blends brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching. mSITE builds on preliminary work indicating that blended mobile interventions are acceptable and both strengthen and shorten cognitive behavioral intervention. Recent work by our group and others indicates that contexts, such as being at home or alone, exacerbates social defeatist attitudes and perceptions of social threat. mSITE is unique in that it uses smartphone sensors (e.g., GPS, conversation sensing) to trigger intervention content tailored to specific social contexts, such as when home alone for extended periods or after a social interaction in the community, in order for cognitive and behavioral interventions to be delivered at the “right place, right time.” In addition, the study will be the first to examine passive sensing measures as outcomes in a clinical trial in SMI, by deriving objective digital markers of negative symptoms and social engagement using smartphone sensors (GPS and microphone) to monitor distance traveled, time spent at home, and conversations. In the R61 phase, we will recruit people with SMI who have limited social engagement. We will then conduct an open trial of mSITE, evaluating whether the intervention leads to clinically significant changes in the frequency of social interactions (the target mechanism). We will also determine the dose of app plus remote coaching necessary to achieve this effect, by evaluating change at 12, 18, or 24 weeks. If go/no go criteria are met (medium effect size increase in social interactions and < 20% dropout) in the R61 phase, the R33 phase will include a randomized trial contrasting mSITE with a therapist and device time-equivalent supportive contact (SC) condition. We will evaluate whether mSITE leads to greater improvement in social interactions, negative symptoms and social functioning relative to SC. We also predict that increases in social interactions will mediate improvements in experiential negative symptoms and social functioning. Our project responds directly to NIMH Strategic Aim 3.1, by evaluating a new behavioral intervention that targets functional improvement and by validating new digital biomarkers for objective measurement of social processes. Our project is also responsive to the NIMH Digital Health Priority Area by advancing digital assessment and context-aware mobile interventions, which are designed to be scalable to community settings.