The Tinnitus Retraining Therapy Trial (TRTT): study protocol for a randomized controlled trial

Roberta W Scherer, Craig Formby, Susan Gold, Sue Erdman, Charles Rodhe, Michele Carlson, Dave Shade, Melanie Tucker, Lee McCaffrey Sensinger, Gordon Hughes, George S Conley, Naomi Downey, Cynthia Eades, Margaret Jylkka, Ada Haber-Perez, Courtney Harper, Shoshannah Kantor Russell, Benigno Sierra-Irizarry, Mark Sullivan, Tinnitus Retraining Therapy Trial Research Group, Craig Formby, Susan Gold, Susan Erdman, Charlotte Nix, Melanie Tucker, Roberta W Scherer, Lee McCaffrey Sensinger, Jennifer Jones, Lisa Lassiter, Matthew Toepfner, April Broadnax, Sravan Nagireddy, Michele Carlson, Dave Shade, Charles Rohde, Lauren Parlett, Alka Ahuja, Gordon Hughes, Cynthia Eades, Courtney Harper, Keva Simmons, Steven Burkhead, Nathan Christensen, Andrea Franzer, Christopher Perro, Ada Haber-Perez, Priscilla George, Patricia Mouck, Emily Vanides, Sean Skelton, Elizabeth Burnett, Shawna Lee, Jeffry Kuhn, Virginia Teti, George Conley, Naomi Downey, Cathy Matthews, Terry Bowen, Bruce Snowden, Joe DeChant, Sara Billari, William Recupero, Michael E Hoffer, Cynthia Kirby, Robert Olsson, Amy Ferrall-Pack, Travis Pfannenstiel, Shoshannah Kantor Russell, Margaret Jylkka, April Hovanec, Andrew Senchak, Martin Sorensen, Michele Spencer, Ben Sierra-Irizarry, Ada Haber-Perez, Mark Sullivan, Mark Packer, Carlos Esquivel, Jay Piccirillo, Judy Dubno, James Henry, Jennifer Schumi, Roberta W Scherer, Craig Formby, Susan Gold, Sue Erdman, Charles Rodhe, Michele Carlson, Dave Shade, Melanie Tucker, Lee McCaffrey Sensinger, Gordon Hughes, George S Conley, Naomi Downey, Cynthia Eades, Margaret Jylkka, Ada Haber-Perez, Courtney Harper, Shoshannah Kantor Russell, Benigno Sierra-Irizarry, Mark Sullivan, Tinnitus Retraining Therapy Trial Research Group, Craig Formby, Susan Gold, Susan Erdman, Charlotte Nix, Melanie Tucker, Roberta W Scherer, Lee McCaffrey Sensinger, Jennifer Jones, Lisa Lassiter, Matthew Toepfner, April Broadnax, Sravan Nagireddy, Michele Carlson, Dave Shade, Charles Rohde, Lauren Parlett, Alka Ahuja, Gordon Hughes, Cynthia Eades, Courtney Harper, Keva Simmons, Steven Burkhead, Nathan Christensen, Andrea Franzer, Christopher Perro, Ada Haber-Perez, Priscilla George, Patricia Mouck, Emily Vanides, Sean Skelton, Elizabeth Burnett, Shawna Lee, Jeffry Kuhn, Virginia Teti, George Conley, Naomi Downey, Cathy Matthews, Terry Bowen, Bruce Snowden, Joe DeChant, Sara Billari, William Recupero, Michael E Hoffer, Cynthia Kirby, Robert Olsson, Amy Ferrall-Pack, Travis Pfannenstiel, Shoshannah Kantor Russell, Margaret Jylkka, April Hovanec, Andrew Senchak, Martin Sorensen, Michele Spencer, Ben Sierra-Irizarry, Ada Haber-Perez, Mark Sullivan, Mark Packer, Carlos Esquivel, Jay Piccirillo, Judy Dubno, James Henry, Jennifer Schumi

Abstract

Background: Subjective tinnitus is the perception of sound in the absence of a corresponding external sound for which there is no known medical etiology. For a minority of individuals with tinnitus, the condition impacts their ability to lead a normal lifestyle and is severely debilitating. There is no known cure for tinnitus, so current therapy focuses on reducing the effect of tinnitus on the patient's quality of life. Tinnitus retraining therapy (TRT) uses nonpsychiatric tinnitus-specific educational counseling and sound therapy in a habituation-based protocol to reduce the patient's tinnitus-evoked negative reaction to, and awareness of, the tinnitus, with the ultimate goal of reducing the tinnitus impact on the patient's quality of life. Some studies support the efficacy of TRT, but no trial to date has compared TRT with the current standard of care or evaluated the separate contributions of TRT counseling and sound therapy. The Tinnitus Retraining Therapy Trial (TRTT) is a randomized, double-blind, placebo-controlled, multicenter trial for individuals with intolerable tinnitus.

Methods/design: The TRTT is enrolling active-duty and retired military personnel and their dependents with functionally adequate hearing sensitivity and severe tinnitus at US Air Force, Navy, and Army medical centers. Eligible study participants are randomized to TRT, partial TRT, or standard care to determine the efficacy of TRT and its components (TRT counseling and sound therapy). The primary outcome is change in score on the Tinnitus Questionnaire assessed longitudinally between baseline and follow-up (3, 6, 12, and 18 months following treatment). Secondary outcomes include subscale score changes in the Tinnitus Questionnaire, overall and subscale score changes in the Tinnitus Functional Index and Tinnitus Handicap Inventory, and change in the visual analog scale of the TRT Interview Form. Audiological outcomes include tinnitus pitch and loudness match and measures of loudness discomfort levels. The incidence of depression as a safety measure is assessed at each visit using the Beck Depression Inventory Fast Screen.

Trial registration: Clinicaltrials.gov NCT01177137.

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Source: PubMed

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