Tinnitus Clinical Trial
Official title:
Telehealth Tinnitus Intervention for Patients With TBI
This study will continue the investigators' 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 telephone-based program for Veterans and military personnel who have experienced TBI. Adaptation of PTM as a telephone-based program 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.
Traumatic brain injury (TBI) is strongly associated with tinnitus. Tinnitus management for
Veterans and military members with TBI has become a critical concern. The investigators'
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).
The investigators 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 Telephone Tinnitus Education (TTE). Preliminary data analyses
indicate that TTE is effective. The present study will modify the TTE program in accordance
with pilot study findings and evaluate the modified TTE using a randomized clinical trial
design.
The 4-year study will be based at the VA National Center for Rehabilitative Auditory
Research (NCRAR). TTE will be implemented and evaluated in a randomized clinical trial.
Qualified candidates will be randomized to receive either immediate-TTE or Wait-List Control
(WLC). All subjects will complete questionnaires at baseline and at 3, 6, 9, and 12 months
post-baseline. The WLC group will receive TTE after completing the 6-month questionnaires.
The primary outcome measure will be the Tinnitus Handicap Inventory (THI).
TTE intervention involves a series of seven telephone appointments, conducted at
approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized.
Telephone education is provided by the Study Psychologist at weeks 1, 3, and 5, and by the
Study Audiologist at weeks 2 and 4, and months 3 and 6.
TTE has the potential of providing needed tinnitus services to Veterans and active military
personnel across the country for a relatively small cost and with minimal impact on
individual VA hospitals.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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