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。TBI的退伍军人和军事人员的培训管理已成为一个关键问题。我们的研究重点是为退伍军人开发有效的，以证据为基础的耳鸣管理方法。这些努力导致了渐进式时间管理（PTM）的发展。我们正在完成一项试点研究，以适应PTM，以满足退伍军人和军人与TBI使用一种新的家庭为基础的远程医疗计划称为远程医疗耳鸣干预（TTI）独特的耳鸣管理需求。初步的数据分析表明TTI是有效的。本研究将根据初步研究结果修改TTI计划，并使用随机临床试验设计评价修改后的TTI。 在最初的3个月，TTI将进一步修改，以更有效地实施，并提高效率和治疗效果。将向所有潜在招募中心提供研究和招募传单的相关信息。传单将包括一个免费电话号码，感兴趣的呼叫者与研究助理（RA）交谈，研究助理（RA）进行筛选，以确定：（a）呼叫者是否有耳鸣问题而无法进行干预;（B）呼叫者可能的TBI状态;以及（c）呼叫者是否在过去2年内进行过听力评估（如果推荐，使用助听器）。通过筛选的呼叫者将收到一个包含知情同意书（ICF）和基线问卷的包裹。筛选后约一周，研究协调员（RC）致电候选人，（a）解释ICF;（B）评估同意能力;（c）提供填写和返回问卷和ICF的说明。RC收到签署的ICF后，研究心理学家致电受试者，确定TBI状态，并进行焦虑、抑郁、PTSD和睡眠障碍筛查。在该呼叫之后，RC随机分配参与者接受即时TTI或住院治疗（UC）。(UC参加者将在6个月后获得TTI。所需的参与者总数（基于功效分析）为336人。每个类别的受试者预测数量（基于初步研究招募率）为轻度TBI 168例，中度/重度TBI 24例，无TBI 144例（总n=336）。 TTI干预包括在收到签署的ICF后约2、3、4、5和6周以及3和6个月进行的一系列7次电话预约。在TTI预约1之前，参与者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，这在预约3和5（第4周和第6周）继续。在预约2（第3周）时，研究听力学家启动听力学咨询，并在预约4、6和7（第5周、第3个月和第6个月）时继续进行。如有必要，可增加预约，以满足干预需求。参与者在基线和基线后3、6、9和12个月完成问卷调查。UC组在完成6个月的问卷调查后接受TTI。主要的结果指标是TinnessHandicap Inventory。 公共卫生相关性： 项目叙述：虽然耳鸣长期以来一直是退伍军人的问题，它已大大升级为一个问题，在过去十年。这种增加主要是由于暴露在高水平的噪音在军队，但也因为耳鸣往往与创伤性脑损伤和创伤后应激障碍-“签名损伤”的伊拉克和阿富汗冲突。虽然耳鸣是如此常见的退伍军人，退伍军人事务部医疗中心还没有统一的耳鸣管理方法。拟议的研究将继续我们的努力，为退伍军人开发耳鸣管理协议。更具体地说，这项研究将开发和评估适应渐进式创伤管理（PTM）作为远程医疗计划的退伍军人和军事人员谁经历了TBI。将PTM改造为基于家庭的远程医疗服务，有可能以相对较小的成本为患有或未患有TBI的退伍军人提供所需的耳鸣服务，并且对个别退伍军人管理局医院的影响最小。

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.