Novel, On-demand VR for Accessible, Practical, and Engaging therapy (NO VAPE)

新颖的按需 VR，可实现无障碍、实用且引人入胜的治疗（无 VAPE）

• 批准号: 10740956
• 负责人: Bethany K Bracken
• 金额: $ 32万
• 依托单位: CHARLES RIVER ANALYTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10740956
• 关键词: Abstinence; Adherence; Adolescent; Adult; Adverse reactions; Age; Behavior; Behavioral; Chronic; Clinical; Clinical Trials; Cognitive; Cognitive Therapy; Conduct Clinical Trials; Control Groups; Education; Ensure; Environment; Evaluation; Feedback; Foundations; Future; Gastrointestinal Diseases; General Hospitals; Government; Health; Health Services Accessibility; Heart Diseases; High School Student; Human; Hybrids; Instruction; Intervention; Interview; Market Research; Marketing; Massachusetts; Medical Device; Mental Health Services; Mental disorders; National Institute of Drug Abuse; Nicotine Dependence; Oral health; Outcome; Patients; Persons; Phase; Phase II Clinical Trials; Psychology; Publishing; Remote session; Reporting; Respiration Disorders; Risk; Safety; Schools; Single-Blind Study; Small Business Innovation Research Grant; Solid; Substance Use Disorder; Technology; Testing; Text Messaging; Therapeutic Intervention; Tobacco smoking behavior; Transportation; Validation; Visit; Youth; barrier to care; clinical care; clinical practice; commercialization; cost; craving; design; digital treatment; efficacy testing; evidence base; experience; experimental group; health care availability; improved; innovation; lung injury; meetings; never smoking; nicotine cessation; non-smoking; novel; phase 2 study; programs; prolonged abstinence; randomized trial; randomized, clinical trials; satisfaction; skills; smoking cessation; social health determinants; success; systemic barrier; tool; traditional therapy; treatment as usual; vaper; vaping; vaping nicotine; virtual reality; virtual reality environment

Project Summary/Abstract Vaping is an increasing problem in the US, carrying significant health risks. In 2019, 25% of high school students reported past month vaping. One million adolescents and 1.3 million never-smoking adults are now dependent on vaped nicotine. Nicotine vaping is associated with multiple adverse reactions including oral health issues, lung injury, and cardiac, respiratory, and gastrointestinal disorders. Limited vaping cessation interventions have been developed; and current treatments have limited accessibility due to systemic barriers to care, including scarcity of treaters, and high cost. Digital therapeutics (DTx) can be used to reduce these barriers; the current DTx is This Is Quitting (TIQ), a free text messaging application that uses education and behavioral psychology to support vaping cessation. TIQ is the only intervention with proven efficacy for nicotine vaping cessation to date. Embedding CBT content into virtual reality (VR) is a strategy Charles River Analytics employed in a successful NIDA SBIR, Constructed Environments for Successfully Sustaining Abstinence Through Immersive, On-Demand Treatment (CESSATION), developed in partnership with Drs. Corinne Cather and Eden Evins at Massachusetts General Hospital. Here, we propose to develop and test an engaging and immersive VR-based cognitive behavioral therapy (CBT) app focused instead on vaping: Novel, On-demand VR for Accessible, Practical, and Engaging therapy (NO VAPE). NO VAPE allows users to practice CBT skills gained in traditional therapy, and provides accessible, immersive, engaging, and ecologically valid practice, motivating greater intervention adherence and satisfaction, and removing many barriers to care access. Thus, we hypothesize that NO VAPE will enhance vaping cessation outcomes in chronic vapers who want to quit. In Phase I, we will: (1) produce 10 VR-based narratives designed to remain novel and engaging across persistent use, (2) solicit feedback from payors and FDA to ensure positive coverage decisions by payors and meet FDA standards, (3), conduct Human Factors studies to ensure a low-risk application before Phase II. In Phase II, we will: (4) conduct a Clinical Trial to test whether NO VAPE is safe and effective so it can augment or change clinical practice, and (5) prepare to market NO VAPE to potential users. A commercially-available VR-integrated CBT tool for clinicians and patients will improve clinical practice, and make CBT available to consumers directly if they wish to use it on their own, helping more people quit vaping.

项目总结/摘要 电子烟在美国是一个日益严重的问题，带来了重大的健康风险。2019年，25%的高中生 报告说上个月吸了电子烟100万青少年和130万从不吸烟的成年人现在依赖 吸尼古丁尼古丁电子烟与多种不良反应有关，包括口腔健康问题， 肺损伤和心脏、呼吸和胃肠道疾病。有限的vaping停止干预措施 由于系统性的护理障碍，目前的治疗方法有限，包括 缺乏竞争对手，成本高。数字治疗（DTx）可以用来减少这些障碍;目前， DTx是This Is Quitting（TIQ），一个免费的短信应用程序，使用教育和行为心理学 来支持戒烟TIQ是唯一一种被证明对尼古丁戒烟有效的干预措施， 约会将CBT内容嵌入虚拟现实（VR）是Charles River Analytics在一个 成功的NIDA SBIR，通过沉浸式成功维持禁欲的构建环境， 按需治疗（CESSATION），与Corinne Cather和Eden Evins博士合作开发， 马萨诸塞州综合医院。在这里，我们建议开发和测试一个引人入胜的沉浸式VR 认知行为疗法（CBT）应用程序专注于vaping：小说，按需虚拟现实， 实用，和从事治疗（无VAPE）. NO VAPE允许用户练习在传统课程中获得的CBT技能 治疗，并提供可访问的，身临其境的，引人入胜的，生态有效的实践，激励更大的 干预依从性和满意度，并消除许多障碍，以获得护理。因此，我们假设， 没有VAPE会提高想要戒烟的慢性vapers的戒烟效果。在第一阶段，我们会：（1） 制作10个基于VR的叙述，旨在保持新颖性，并在持续使用中保持吸引力，（2）征求 付款人和FDA的反馈，以确保付款人做出积极的承保决定，并符合FDA的标准，（3）， 进行人为因素研究，以确保在第二阶段之前进行低风险应用。在第二阶段，我们将：（4）进行 一项临床试验，以测试无VAPE是否安全有效，因此它可以增加或改变临床实践，以及 (5)准备向潜在用户推销无蒸汽。面向临床医生的市售VR集成CBT工具 患者将改善临床实践，如果消费者希望使用CBT， 帮助更多的人戒烟