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

项目摘要/摘要 本实验疗法R61/R33提案响应RFA-MH-18-704。这个项目的目标是 是评估一种新的技术支持的混合式干预措施，旨在减少社会孤立和改善 严重精神疾病(SMI)的社会功能社交孤立在SMI中很常见，并导致发病率和 限制功能恢复。不幸的是，几乎没有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 快感缺乏症。此外，这一领域的干预发展受到不准确的社会测量的限制。 交互、流程和相关构造。我们新的混合式干预，移动社交互动疗法 通过曝光(MSite)，将简短的面对面心理治疗与情景触发的移动智能手机相结合 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 干预是可以接受的，并且既加强又缩短了认知行为干预。最近的工作由 我们小组和其他人指出，环境，如在家或独自一人，会加剧社会失败主义 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， 对话感知)以触发针对特定社交环境量身定做的干预内容，例如在家时 在很长一段时间内独处或在社区中进行社交后，以便认知和行为 干预措施要在“正确的地点，正确的时间”进行。此外，这项研究将是第一个检查 被动感知测量作为SMI临床试验的结果，通过推导出客观的阴性数字标记物 使用智能手机传感器(GPS和麦克风)监控距离的症状和社交活动 旅行，在家中度过的时间，以及交谈。在R61阶段，我们将招募具有SMI的人员 社交参与度有限。然后我们将对mSite进行公开试验，评估干预是否 导致临床上社会互动频率的显著变化(目标机制)。我们还将 通过在12岁时评估变化，确定实现这一效果所需的APP加远程教练的剂量， 18周，或24周。如果满足GO/NO GO标准(社交互动中的中等效果规模增加和20% 退出)在R61阶段，R33阶段将包括一项随机试验，将mSite与治疗师和 设备时间当量支持接触(SC)条件。我们将评估mSite是否会带来更大的 与SC相比，社交互动、阴性症状和社交功能均有改善。我们还预测 社交互动的增加将中介经验性负面症状和社交的改善 功能正常。我们的项目通过评估一种新的行为干预直接响应NIMH战略目标3.1 它的目标是改善功能，并通过验证新的数字生物标记物来客观衡量社会 流程。我们的项目也响应NIMH数字健康优先领域，通过推进数字 评估和情景感知移动干预，旨在根据社区环境进行扩展。

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.