Rationale for the tinnitus retraining therapy trial
Craig Formby, Roberta Scherer, TRTT Study Group, Ben Sierra, Ada Haber-Perez, Mark Sullivan, Mark Packer, Carlos Esquivel, Cynthia Eades, Courtney Harper, Keva Simmons, Steven Burkhead, Nathan Christensen, Michele Spencer, Margaret Jylka, Shosannah Kantor, Martin Sorensen, Virginia Teti, George Conley, Naomi Downey, Cathy Matthews, Bruce Snowden, Jow DeChant, Sara Billari, Adriana Farrar, Cynthia Kirby, Amy Ferrell-Pack, Robert Olsson, Rebecca Ellman, John Nicholson, Pfannenstiel Travis, Mile Hoffer, Priscilla Goerge, Patricia Mouck, Emily Vanides, Sean Skelton, Susan Gold, Susan Erdman, Charlotte Nix, Melanie Tucker, Lee Jensinger, Jeni Jones, Lisa Lassiter, Matthew Toepfner, April Broadnax, Alka Ahuja, Gordon Hughes, Craig Formby, Roberta Scherer, TRTT Study Group, Ben Sierra, Ada Haber-Perez, Mark Sullivan, Mark Packer, Carlos Esquivel, Cynthia Eades, Courtney Harper, Keva Simmons, Steven Burkhead, Nathan Christensen, Michele Spencer, Margaret Jylka, Shosannah Kantor, Martin Sorensen, Virginia Teti, George Conley, Naomi Downey, Cathy Matthews, Bruce Snowden, Jow DeChant, Sara Billari, Adriana Farrar, Cynthia Kirby, Amy Ferrell-Pack, Robert Olsson, Rebecca Ellman, John Nicholson, Pfannenstiel Travis, Mile Hoffer, Priscilla Goerge, Patricia Mouck, Emily Vanides, Sean Skelton, Susan Gold, Susan Erdman, Charlotte Nix, Melanie Tucker, Lee Jensinger, Jeni Jones, Lisa Lassiter, Matthew Toepfner, April Broadnax, Alka Ahuja, Gordon Hughes
Abstract
The Tinnitus Retraining Therapy Trial (TRTT) is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT) and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1) directive counseling and sound therapy using conventional sound generators; (2) directive counseling and placebo sound generators; or (3) standard of care as administered in the military. Study centers include a Study Chair's Office, a Data Coordinating Center, and six Military Clinical Centers with treatment and data collection standardized across all clinics. The primary outcome is change in Tinnitus Questionnaire (TQ) score assessed longitudinally at 3, 6, 12, and 18-month follow-up visits. Secondary outcomes include: Change in TQ sub-scales, Tinnitus Handicap Inventory, Tinnitus Functional Index, and TRT interview visual analog scale; audiometric and psychoacoustic measures; and change in quality of life. The TRTT will evaluate TRT efficacy by comparing TRT (directive counseling and conventional sound generators) with standard of care; directive counseling by comparing directive counseling plus placebo sound generators versus standard of care; and sound therapy by comparing conventional versus placebo sound generators. We hypothesize that full TRT will be more efficacious than standard of care, directive counseling and placebo sound generators more efficacious than standard of care, and conventional more efficacious than placebo sound generators in habituating the tinnitus awareness, annoyance, and impact on the study participant's life.
Conflict of interest statement
Conflict of Interest: None declared.
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Source: PubMed