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: 10356328
• 负责人: Colin A. Depp
• 金额: $ 78.8万
• 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: 2022-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10356328
• 关键词: Address; Anhedonia; Anxiety; Area; Attitude; Awareness; Behavior Therapy; Belief; Biological Markers; Cellular Phone; Clinical; Clinical Trials; Cognitive; Cognitive Therapy; Communities; Devices; 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; base; behavior change; clinically significant; community setting; design; digital; 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.

项目摘要/摘要 这种实验疗法R61/R33对RFA-MH-18-704的建议反应。这个项目的目标 是评估旨在减少社会隔离和改善的新技术支持的混合干预措施 严重精神疾病（SMI）的社会功能。社会隔离在SMI中很常见，并导致发病率和 限制功能恢复。不幸的是，很少有可用的干预措施专门针对社会隔离及其 在SMI中确定包括焦虑的社会回避，失败者参加互动和社会 阿内多尼亚。此外，该领域的干预发展受到社会的隐含度量的限制 交互，过程和相关结构。我们的新混合干预，移动社会互动疗法 通过曝光（MSITE），将简短的面对面心理治疗与上下文触发的移动智能手机混合 干预和远程电话教练。 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，并且认知行为干预既强大又缩短。最近的工作 我们的小组和其他人表明，例如在家中或独自一人，加剧了社会失败者的背景 对社会威胁的态度和看法。 MSITE是独一无二的，因为它使用智能手机传感器（例如GPS， 对话敏感性）以触发针对特定社会环境的干预内容，例如回家时 为了认知和行为，独自一人或社区的社交互动之后 干预措施要在“正确的地方，正确的时间”。此外，该研究将是第一个考试的研究 通过得出负面的客观数字标记，在SMI的临床试验中，被动敏感性度量作为结果 使用智能手机传感器（GP和麦克风）监视距离的症状和社交参与度 旅行，在家度过的时间以及对话。在R61阶段，我们将招募有SMI的人 社会参与度有限。然后，我们将对MSITE进行公开试验，评估是否干预 导致社交相互作用频率（目标机制）的临床显着变化。我们也会 确定应用程序的剂量以及实现此效果所需的远程教练，通过评估12时的变化， 18或24周。如果满足/否GO标准（社交互动的中等效果大小增加，<20％ 在R61阶段，R33阶段将包括一个随机试验，将MSITE与治疗师和治疗师进行对比 设备时间等效的支持接触（SC）条件。我们将评估MSITE是否导致更大 相对于SC的社交互动，负面症状和社会功能的改善。我们也预测 社交互动的增加将调解专家负面症状和社会的改善 功能。我们的项目通过评估新的行为干预，直接响应NIMH战略目标3.1 这针对功能改进并通过验证新的数字生物标志物来客观地测量社会 过程。我们的项目也通过推进数字来响应NIMH数字健康优先领域 评估和上下文感知的移动干预措施，旨在可扩展到社区环境。