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.

项目摘要/摘要 在美国，烟是一个越来越多的问题，具有重大的健康风险。 2019年，高中生有25％ 报告了过去一个月的烟。现在有100万青少年和130万从未吸烟的成年人依赖 在尼古丁蒸气上。尼古丁蒸发与多种不良反应有关，包括口腔健康问题， 肺损伤以及心脏，呼吸道和胃肠道疾病。有限的胃口戒烟干预措施具有 已开发；由于系统的护理障碍，包括 缺乏治前锋和高昂的成本。数字治疗（DTX）可用于减少这些障碍；电流 DTX是戒烟（TIQ），这是一种使用教育和行为心理学的免费文本消息传递应用程序 支持戒烟。 TIQ是唯一的干预措施，可证明尼古丁蒸发的功效 日期。将CBT内容嵌入虚拟现实（VR）是Charles River Analytics的一项策略 成功的NIDA SBIR，建造了通过沉浸式维持戒酒的环境， 与博士合作开发的按需治疗（停止）。科琳·凯瑟（Corinne Cather）和伊甸园（Eden Evins） 马萨诸塞州综合医院。在这里，我们建议开发和测试基于VR的引人入胜的 认知行为疗法（CBT）应用程序专注于Vaping：新颖的，按需VR，可访问， 实用且引人入胜的疗法（无vape）。没有vape允许用户练习传统的CBT技能 治疗，并提供可及，身临其境，引人入胜且在生态上有效的实践，激励更大 干预依从性和满意度，并消除了许多护理障碍。因此，我们假设 没有vape可以增强想要戒烟的慢性vaper中的戒烟结果。在第一阶段，我们将：（1） 产生10个基于VR的叙述，旨在保持新颖和持续使用，（2）征求 付款人和FDA的反馈，以确保付款人的积极承保范围决定并符合FDA标准，（3）， 进行人为因素研究，以确保在第二阶段之前使用低风险的应用。在第二阶段，我们将：（4）行为 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，并且 （5）准备向潜在用户推销vape。临床医生的商业可用VR综合CBT工具 患者将改善临床实践，并在消费者希望使用时直接提供CBT 独自帮助更多的人退出烟雾。