A Feasibility Study of a Novel, Fully Remote Counseling and Sound Therapy Program for Hyperacusis

项目总结/摘要 根据美国国立卫生研究院和R15区域计划的资助目标，本申请 建议调查远程咨询和声音治疗计划的可行性，以减少反应 到听觉过敏听觉过敏是一种听力状况，导致一个人的声音感知异常响亮， 令人烦恼的、可怕的或痛苦的。听觉过敏的临床管理包括咨询，以减少负 对声音的反应和声音治疗，以改善响度感知。尽管有这些有用的方法， 听觉过敏症的管理仅限于位于大型中心的高度专业化的专业人员， 大多数听觉过敏症患者都无法触及。此外，来自对照试验的研究证据表明， 这些治疗听觉过敏的方法缺乏，只涉及少数参与者，并且仅限于 具体的方法，如认知行为疗法和低水平的背景噪音。针对这些 根据需要，该研究小组开发了听觉过敏活动治疗（HAT），其中包括两个组成部分： 心理咨询和声音疗法其有效性通过从临床焦点获得的数据证明 小组和小规模的研究。HAT还有远程管理的可能性，因此， 解决目前许多农村和低收入美国人面临的获得医疗保健的问题， 听觉过敏 这项拟议的R15项目的目的是收集早期临床证据，证明HAT在缓解 使用一种新颖的远程传递方法来治疗听觉过敏。该项目的创新方面，包括远程 以患者为中心的干预措施的交付和分析，将为基于证据的临床指南提供信息， 目前缺乏和生产更容易获得的解决方案，用于听觉过敏症的管理。第一个目标将评估 远程咨询方案的可行性，其中包括有关主题，家庭作业， 测验以保持参与者的参与，辅导以支持参与者。第二个目标将比较 两个远程管理的声音治疗选项的有效性建议听觉过敏救济，但 尚待临床评估-低水平的背景噪声和连续近似使用麻烦 声音.在目标1中，每名参与者将完成4周的基线测试（对照），然后进行4周的 治疗（Treatment）。在目标2中，参与者将被随机分配到两个声音治疗组中的一个。在 项目结束后，研究团队将获得支持更大规模，多地点， 未来的随机临床试验，将被设计为更充分地评估远程 提供HAT的咨询和定制的声音治疗组件，以减少对听觉过敏的反应。作为 R15区域奖，该项目也将通过提供研究机会产生重大影响 学生研究人员谁将积极参与该项目，并在研究环境，通过提高 PI的工作和推进奥古斯塔纳学院本科生研究的优先事项。

PROJECT SUMMARY/ABSTRACT In line with the funding goals of the National Institutes of Health and the R15 AREA program, this application proposes to investigate the feasibility of a remote counseling and sound therapy program for reducing reactions to hyperacusis. Hyperacusis is a hearing condition causing one’s perception of sounds to be abnormally loud, annoying, fearful, or painful. Clinical management of hyperacusis involves counseling to reduce negative reactions to sounds and sound therapy to improve loudness perception. Despite these helpful approaches, management of hyperacusis is restricted to highly specialized professionals located at large centers that are inaccessible by most hyperacusis patients. Further, research evidence from controlled trials on the effectiveness of these treatments for hyperacusis is lacking, involves only a small number of participants, and is limited to specific approaches, such as cognitive behavioral therapy and low-level background noise. In response to these needs, this research team developed Hyperacusis Activities Treatment (HAT), which includes two components: counseling and sound therapy. Its effectiveness was demonstrated through data obtained from clinical focus groups and small-scale research studies. There is additional potential for HAT to be remotely administered, thus addressing the access-to-care issue currently facing many rural and low-income Americans who are suffering from hyperacusis. The aim of this proposed R15 project is to gather early clinical evidence for the effectiveness of HAT in relieving hyperacusis using a novel, remote delivery approach. The innovative aspects of this project, including the remote delivery and analysis of patient-centered interventions, will inform evidence-based clinical guidelines that are currently lacking and produce more accessible solutions for hyperacusis management. The first aim will evaluate feasibility of the remote counseling program, which includes weekly modules on relevant topics, homework, and quizzes to keep participants engaged, and coaching to support participants. The second aim will compare the effectiveness of two remotely-administered sound therapy options recommended for hyperacusis relief but that are yet to be clinically evaluated—low-level background noise and successive approximations using bothersome sounds. In Aim 1, each participant will complete 4 weeks of baseline testing (control) followed by 4 weeks of counseling (treatment). In Aim 2, participants will be randomized into one of two sound therapy groups. At the end of the project, the research team will have the early clinical evidence needed to support larger, multi-site, future randomized clinical trials that will be designed to more fully evaluate the effectiveness of the remote delivery of HAT’s counseling and customized sound therapy components to reduce reactions to hyperacusis. As an R15 AREA award, the project will also have a significant impact through the research opportunities afforded to student researchers who will be actively involved in the project, and on the research environment by enhancing the PI’s work and advancing priorities of undergraduate research at Augustana College.