Telehealth Tinnitus Intervention for Patients with TBI

描述(由申请人提供)： 项目摘要/摘要创伤性脑损伤(TBI)与耳鸣密切相关。退伍军人和军人脑损伤后的耳鸣管理已成为一个重要的问题。我们的研究重点是为退伍军人开发有效的、循证的耳鸣管理方法。这些努力导致了渐进性耳鸣管理(PTM)的发展。我们正在完成一项试点研究，使用一种名为远程健康耳鸣干预(TTI)的新型家庭远程保健计划，使PTM能够满足患有脑外伤的退伍军人和军人独特的耳鸣管理需求。初步数据分析表明，TTI方法是有效的。本研究将根据先导性研究结果修改TTI计划，并使用随机临床试验设计评估修改后的TTI。在头3个月内，TTI将进一步修改，以更有效地实施，并提高效率和治疗效果。有关研究和招聘传单的信息将提供给所有潜在的招聘网站。传单将包括一个免费电话号码，感兴趣的呼叫者将与研究助理(RA)交谈，研究助理(RA)进行筛查，以确定：(A)呼叫者是否有耳鸣问题，是否需要干预；(B)呼叫者可能的脑损伤状况；以及(C)呼叫者是否在过去两年内进行过听力评估(如果建议使用助听器)。通过筛选的呼叫者将被发送一个包裹，其中包含知情同意表(ICF)和基线问卷。在筛选后大约一周，研究协调员(RC)要求候选人(A)解释ICF；(B)评估同意的能力；以及(C)提供填写和返回调查问卷和ICF的说明。在RC收到签署的ICF后，研究心理学家打电话给参与者，以确定TBI状态，并进行焦虑、抑郁、创伤后应激障碍和睡眠障碍的筛查。在此呼叫之后，RC随机选择参与者接受即时TTI或普通护理(UC)。(UC参与者将在6个月后收到TTI。)(根据权力分析)所需的参与者总数为336人。每个类别的预测受试者数量(根据试点研究的招聘率)为：轻度脑损伤168人，中度/重度脑损伤24人，无脑损伤144人(总计336人)。TTI干预包括一系列的7次电话预约，在大约2、3、4、5和6周，以及在收到签署的ICF后3和6个月进行。在TTI预约1之前，参与者将通过邮件收到自助工作簿。在预约1(第2周)，心理学家开始基于认知-行为疗法(CBT)的干预，该疗法在预约3和5(第4和6周)继续进行。在预约2(第3周)，研究听力专家开始听力学咨询，在预约4、6和7(5周、3个月和6个月)继续进行。如有需要，可安排额外预约，以应付干预需要。参与者在基线以及基线后3、6、9和12个月完成问卷调查。UC组在完成为期6个月的问卷调查后接受TTI。主要的结果衡量标准是耳鸣残障量表。 公共卫生相关性： 项目简介：虽然耳鸣长期以来一直是退伍军人的问题，但在过去的十年里，它已经大大升级为一个问题。这一增长在很大程度上是因为暴露在军队的高水平噪音中，但也因为耳鸣经常与创伤性脑损伤和创伤后应激障碍有关--这是伊拉克和阿富汗冲突的“标志性伤害”。虽然耳鸣在退伍军人中很常见，但退伍军人医学中心还没有统一的耳鸣管理方法。这项拟议的研究将继续努力为退伍军人制定耳鸣管理方案。更具体地说，这项研究将开发和评估进行性耳鸣管理(PTM)的适应性，作为退伍军人和经历过脑外伤的军事人员的远程保健计划。将PTM调整为基于家庭的远程医疗服务，有可能为有和没有脑外伤的退伍军人提供所需的耳鸣服务，成本相对较低，对退伍军人医院的影响最小。

DESCRIPTION (provided by applicant): Project Summary/Abstract Traumatic brain injury (TBI) is strongly associated with tinnitus. Tinnitus management for Veterans and military personnel with TBI has become a critical concern. Our research has focused on developing effective, evidence-based methods of tinnitus management for Veterans. These efforts led to the development of Progressive Tinnitus Management (PTM). We are completing a pilot study to adapt PTM to meet the unique tinnitus management needs of Veterans and military members with TBI using a novel home-based telehealth program called Telehealth Tinnitus Intervention (TTI). Preliminary data analyses indicate that TTI is effective. The present study will modify the TTI program in accordance with pilot study findings and evaluate the modified TTI using a randomized clinical trial design. During the first 3 months, TTI will be further modified for more efficient implementation and to improve efficiency and therapeutic efficacy. Information about the study and recruitment flyers will be provided to all potential recruitment sites. The flyer will include a toll-free telephone number and interested callers talk to the Research Assistant (RA) who conducts screening to determine: (a) if the caller has a tinnitus problem warranting the intervention; (b) the caller's probable TBI status; and (c) if the caller has had a hearing evaluation within the past 2 years (and uses hearing aids if recommended). Callers who pass screening are sent a package containing the informed consent form (ICF) and baseline questionnaires. About one week after screening, the Research Coordinator (RC) calls the candidate to (a) explain the ICF; (b) assess capacity to consent; and (c) provide instructions for completing and returning the questionnaires and ICF. After the signed ICF has been received by the RC, the Study Psychologist calls the participant to determine TBI status and conduct screening for anxiety, depression, PTSD, and sleep disorder. Following this call, the RC randomizes the participant to receive either immediate-TTI or Usual Care (UC). (UC participants will receive TTI after 6 months.) The total number of participants required (based on power analysis) is 336. The predicted number of subjects for each category (based on the pilot study recruitment rates) are 168 for mild TBI, 24 for moderate/severe TBI, and 144 for no TBI (total n=336). TTI intervention involves a series of seven telephone appointments, conducted at approximately 2, 3, 4, 5, and 6 weeks, and 3 and 6 months after receipt of the signed ICF. Prior to TTI Appointment 1, participants receive a self-help workbook by mail. At Appointment 1 (week 2) the Psychologist initiates intervention based on Cognitive-Behavioral Therapy (CBT), which is continued at Appointments 3 and 5 (weeks 4 and 6). At Appointment 2 (week 3), the Study Audiologist initiates audiologic counseling, which continues at Appointments 4, 6, and 7 (week 5, months 3 and 6). Additional appointments can be made if necessary to meet intervention needs. Participants complete questionnaires at baseline and at 3, 6, 9, and 12 months post- baseline. The UC group receives TTI after completing the 6-month questionnaires. The primary outcome measure is the Tinnitus Handicap Inventory. PUBLIC HEALTH RELEVANCE: Project Narrative: Although tinnitus has long been a problem for Veterans, it has greatly escalated as a problem during the last decade. This increase is due largely because of exposure to high levels of noise in the military, but also because tinnitus often is associated with traumatic brain injury and post-traumatic stress disorder-"signature injuries" of the Iraq and Afghanistan conflicts. Although tinnitus is so common with Veterans, VA medical centers have not had uniform methods of tinnitus management. The proposed study will continue our efforts to develop tinnitus management protocols for Veterans. More specifically, this study will develop and evaluate an adaptation of Progressive Tinnitus Management (PTM) for use as a telehealth program for Veterans and military personnel who have experienced TBI. Adaptation of PTM as a home-based telehealth service has the potential of providing needed tinnitus services to Veterans with and without TBI for a relatively small cost and with minimal impact on individual VA hospitals.