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.
