Study of a PST-Trained Voice-Enabled Artificial Intelligence Counselor (SPEAC) for Adults with Emotional Distress

针对患有情绪困扰的成年人的经过 PST 培训的语音人工智能咨询师 (SPEAC) 的研究

• 批准号: 10611145
• 负责人: Olusola A. Ajilore
• 金额: $ 108.87万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-03 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10611145
• 关键词: Address; Adult; Affect; Amygdaloid structure; Anxiety; Area; Artificial Intelligence; Attitude; Brain; Clinical; Cognition; Cognitive; Computer software; Development; Devices; Dorsal; Dose; Emotional; Emotions; Engineering; Enrollment; Evaluation; Face; Focus Groups; Functional Magnetic Resonance Imaging; Functional disorder; Future; Generalized Anxiety Disorder; Health; Health Promotion; Health Resources; Human; Image Analysis; Intelligence; Lateral; Length; Machine Learning; Measurement; Measures; Mediating; Mental Depression; Mental Health; Mental Health Services; Moods; Names; Neurosciences; Outcome; Participant; Patient Outcomes Assessments; Patient Self-Report; Patients; Personal Satisfaction; Persons; Phase; Prefrontal Cortex; Problem Solving; Procedures; Process Measure; Productivity; Professional counselor; Protocols documentation; Psychotherapy; Public Health; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Research; Secure; Specific qualifier value; Stress; Surveys; Symptoms; Techniques; Testing; Therapeutic; Time; Training; Translating; Treatment Efficacy; United States National Institutes of Health; Voice; Voice Training; Waiting Lists; active control; active method; anxiety symptoms; arm; base; behavioral health intervention; clinical decision support; cognitive control; connected care; coping; cost; depressive symptoms; digital medicine; disability; efficacy testing; emotional distress; experience; follow up assessment; formative assessment; improved; innovation; insight; intelligent agent; iterative design; knowledge base; meetings; neural circuit; neuromechanism; new technology; novel; pilot test; problem solving therapy; prototype; recruit; relating to nervous system; social stigma; targeted treatment; theories; treatment arm; treatment optimization; usability; user centered design; virtual; virtual health

PROJECT SUMMARY BACKGROUND: Depression and anxiety are the leading causes of disability and lost productivity, and are often underdiagnosed and undertreated owing to access, cost, and stigma barriers. Novel and scalable psychotherapies are urgently needed. Advances in artificial intelligence (AI) offer a transformative opportunity to develop intelligent voice assistants as virtual health agents accessible on personal devices. Meanwhile, major advances in human neuroscience have fueled a paradigm shift to study brain mechanisms underlying behavioral health interventions. OBJECTIVES: Leveraging our collaborative team’s transdisciplinary expertise in these emerging areas, we will develop and rigorously test a novel voice-enabled, AI virtual agent named Lumen, trained on Problem Solving Therapy (PST), for patients with moderate, untreated depressive and/or anxiety symptoms. We will investigate the effect of Lumen on engagement of a priori neural targets—amygdala for emotional reactivity and dorsal lateral prefrontal cortex (DLPFC) for cognitive control—as putative mechanisms. DESIGN/ METHODS: The project has 2 phases. In the R61 phase (years 1-2), we will further develop Lumen building on the current prototype and conduct iterative user-centered design evaluations that include focus groups, scenario-based clinician evaluations, and a formative user study with 20 participants. We will pilot test Lumen in a 2-arm randomized clinical trial (RCT, Study 1), with 60 participants with depression and/or anxiety randomized in a 2:1 ratio to receive PST with Lumen (n=40) on a secure study iPad or be on a waitlist (n=20). At weeks 0 and 14, participants will complete functional magnetic resonance imaging (fMRI) to assess neural target engagement as well as validated surveys of patient-reported outcomes (e.g., depressive and anxiety symptoms, functioning, quality of life). In addition, they will complete naturalistic end-of-day assessments of mood, stress, appraisal and coping for 7 days every 2 weeks. If the Go milestone criteria are met, the R33 phase (years 3-5) will include a 3-arm RCT (Study 2) with 200 new participants randomized in a 2:1:1 ratio to 1 of 3 arms: Lumen (n=100), waitlist control (n=50), and in-person PST as active control (n=50). Participants will complete baseline and follow-up assessments using a refined measurement protocol based on Study 1. SPECIFIC AIMS: R61 aims are to (1) establish the functionality, usability, and treatment fidelity of Lumen; and (2) demonstrate feasibility, acceptability, and neural target engagement according to pre-specified Go milestone criteria. R33 aims are to (1) confirm neural target engagement by a superiority test (primary) comparing the Lumen and waitlist control arms and a noninferiority test (secondary) comparing the Lumen and in-person PST arms; and (2) examine the relationships of target engagement to outcomes. The results will provide the basis for future confirmatory efficacy testing of Lumen. IMPACT: This project’s public health impact lies in that a mechanistically tested, PST-trained AI agent could bring proven psychotherapy to people with depression/anxiety who do not seek professional help or who desire more personalized, connected care.

项目摘要 背景：抑郁和动画是残疾和生产力失去的主要原因，是 由于获得，成本和污名障碍，经常被诊断不足和治疗不足。新颖而可扩展的 迫切需要心理治疗。人工智能的进步（AI）提供了变革性的机会 将智能的语音助手发展为可以在个人设备上访问的虚拟卫生代理商。同时， 人类神经科学的重大进展已被助长了研究脑机制的范式转变 行为健康干预措施。目标：利用我们协作团队的跨学科专业知识 在这些新兴领域，我们将开发并严格测试一种新颖的语音，AI虚拟代理 对中度，未治疗抑郁症和/或 焦虑症状。我们将研究管腔对先验神经靶标的影响 - amygdala 为了认知控制，用于情绪反应性和背侧前额叶皮层（DLPFC） 机制。设计/方法：该项目有2个阶段。在R61阶段（1-2年），我们将进一步 在当前的原型上开发灯具建筑物，并进行以用户为中心的迭代设计评估 包括焦点小组，基于方案的临床评估以及20名参与者的形成性用户研究。我们 将在2臂随机临床试验（RCT，研究1）中进行试验腔，有60名参与者 和/或动画以2：1的比例随机分配，以在安全研究iPad上接受Lumen（n = 40）接收PST或在A上 候补名单（n = 20）。在第0和第14周，参与者将完成功能磁共振成像（fMRI）到 评估神经目标参与以及对患者报告结果的验证调查（例如，抑郁症 和焦虑症状，功能，生活质量）。此外，他们将完成自然主义的一天结束 每2周对情绪，压力，评估和应对的评估。如果GO里程碑标准是 Met，R33阶段（3-5年）将包括3臂RCT（研究2），其中200名新参与者随机分配 2：1：1与3个臂的比率：腔：候补名单控制（n = 50）和面对面的PST作为主动对照（n = 50）。 参与者将使用基于精制的测量协议来完成基线和随访评估 研究1。具体目的：R61的目的是（1）建立功能，可用性和治疗保真度 流明; （2）根据预先指定的可行性，可接受性和神经目标参与 遵循里程碑标准。 R33的目的是（1）通过优越测试（主要）确认神经元目标参与 比较管腔和候补控制臂和非劣效率测试（次要），以比较管腔和 面对面的PST武器； （2）检查目标参与与结果的关系。结果将 为管腔的未来确认有效性测试提供了基础。影响：该项目的公共卫生影响 谎言是经过机械测试的，受PST训练的AI代理可以为患有心理治疗的人 不寻求专业帮助或渴望更个性化，连接的护理的抑郁症/焦虑。