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

用于严重精神疾病社交康复的情境感知移动干预

• 批准号: 10544170
• 负责人: Colin A. Depp
• 金额: $ 72.77万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-10 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10544170
• 关键词: Acceleration; Address; Anhedonia; Anxiety; Area; Attitude; Awareness; Behavior Therapy; Belief; Cellular Phone; Clinical; Clinical Trials; Cognitive; Cognitive Therapy; Communities; Devices; Digital biomarker; Distal; Dose; Dropout; Ecological momentary assessment; Emotional; Exposure to; Frequencies; Goals; Health Priorities; Home; Individual; Intervention; Investigational Therapies; Link; Location; Measurement; Measures; Mediating; Mediation; Monitor; Mood Disorders; Morbidity - disease rate; National Institute of Mental Health; Outcome; Outpatients; Participant; Patient Self-Report; Perception; Performance; Persons; Phase; Process; Psychoses; Psychotherapy; Recovery; Recovery of Function; Research; Resources; Rewards; Sampling; Schizophrenia; Severities; Site; Social Behavior; Social Environment; Social Functioning; Social Interaction; Social Perception; Social Processes; Social isolation; Symptoms; System; Technology; Therapeutic Intervention; Time; Travel; Work; anxious; automated intervention; behavior change; clinically significant; community setting; design; digital assessment; digital health; disability; economic impact; experience; functional improvement; improved; microphone; mortality; new technology; novel; physical conditioning; positive emotional state; randomized trial; recruit; response; sensor; severe mental illness; smartphone application; social; social deficits; social engagement; social interventions; telecoaching; telephone coaching; therapy development

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.

项目概要/摘要 该实验疗法 R61/R33 提案响应 RFA-MH-18-704。该项目的目标 是评估一种新技术支持的混合干预措施，旨在减少社会孤立并改善 严重精神疾病（SMI）中的社会功能。社会隔离在 SMI 中很常见，会导致发病和 限制功能恢复。不幸的是，很少有专门针对社会隔离及其影响的可用干预措施 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，该领域干预措施的发展受到对社会的不精确衡量的限制。 交互、过程和相关结构。我们新的混合干预，移动社交互动疗法 by Exposure (mSITE)，将简短的面对面心理治疗与情境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 干预措施是可以接受的，并且可以加强和缩短认知行为干预。最近的工作 我们的小组和其他人表明，在家或独自一人等环境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）触发针对特定社交环境（例如在家时）定制的干预内容 长时间独自一人或在社区进行社交互动后，为了认知和行为 干预措施应在“正确的地点、正确的时间”进行。此外，该研究将首先检验 被动传感测量作为 SMI 临床试验的结果，通过导出阴性的客观数字标记 使用智能手机传感器（GPS 和麦克风）监测距离的症状和社交参与 旅行、在家度过的时间和谈话。在R61阶段，我们将招募具有SMI的人员 有限的社会参与。然后我们将进行 mSITE 的公开试验，评估干预措施是否有效 导致社交互动频率的临床显着变化（目标机制）。我们还将 通过评估 12 时的变化，确定实现此效果所需的应用程序加远程指导的剂量， 18 或 24 周。如果满足通过/不通过标准（社交互动中的中等效应大小增加且 < 20% 在 R61 阶段中，R33 阶段将包括一项将 mSITE 与治疗师进行对比的随机试验，以及 设备时间等效支持接触 (SC) 条件。我们将评估 mSITE 是否会带来更大的效益 与 SC 相比，社交互动、阴性症状和社会功能得到改善。我们还预测 社交互动的增加将促进体验性负面症状和社交能力的改善 发挥作用。我们的项目通过评估新的行为干预措施来直接响应 NIMH 战略目标 3.1 以功能改善为目标，并通过验证新的数字生物标记来客观测量社会 流程。我们的项目还通过推进数字化来响应 NIMH 数字健康优先领域 评估和情境感知移动干预措施，旨在可扩展到社区环境。