TY - JOUR
T1 - The Tinnitus Retraining Therapy Trial (TRTT)
T2 - Study protocol for a randomized controlled trial
AU - Tinnitus Retraining Therapy Trial Research Group
AU - Scherer, Roberta W.
AU - Formby, Craig
AU - Gold, Susan
AU - Erdman, Sue
AU - Rodhe, Charles
AU - Carlson, Michele
AU - Shade, Dave
AU - Tucker, Melanie
AU - Sensinger, Lee Mc Caffrey
AU - Hughes, Gordon
AU - Conley, George S.
AU - Downey, Naomi
AU - Eades, Cynthia
AU - Jylkka, Margaret
AU - Haber-Perez, Ada
AU - Harper, Courtney
AU - Russell, Shoshannah Kantor
AU - Sierra-Irizarry, Benigno
AU - Sullivan, Mark
N1 - Funding Information:
Organizational units of the TRTT include a study chair’s office, a data coordinating center, clinical centers, and various committees. The National Institute on Deafness and Other Communication Disorders (NIDCD) at the National Institutes of Health funds the TRTT through a cooperative grant arrangement and provides a project officer. Leadership in the TRTT is shared by the study chair and the director of the data coordinating center.
Publisher Copyright:
© 2014 Scherer et al.; licensee BioMed Central Ltd.
PY - 2014/10/15
Y1 - 2014/10/15
N2 - 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.
AB - 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.
KW - Randomized clinical trial
KW - Tinnitus
KW - Tinnitus retraining therapy
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U2 - 10.1186/1745-6215-15-396
DO - 10.1186/1745-6215-15-396
M3 - Article
C2 - 25319676
AN - SCOPUS:84934293653
SN - 1745-6215
VL - 15
JO - Trials
JF - Trials
IS - 1
M1 - 396
ER -