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

Abstract

BackgroundSubjective 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/designThe 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 registrationClinicaltrials.gov NCT01177137.

Tinnitus Functional Index: Development, validation, outcomes research, and clinical application

“…The TFI is being utilized in numerous clinical trials, including in the United Kingdom (Fackrell et al, 2013), New Zealand (Chandra, 2013), and the United States (Scherer et al, 2014;Henry et al, 2015). Because of this high level of interest, it is important to provide general guidelines for administering the TFI and for interpreting results.…”

Logistic regression analysis of factors influencing the effectiveness of intensive sound masking therapy in patients with tinnitus

“…Participants with a flat audiogram were more likely to respond positively to the intensive sound masking intervention than those with a HFSS audiogram but there was no relation to an average hearing threshold profile. To our best knowledge, no previous study has investigated the influence of audiometric configuration on the outcome of tinnitus intervention, even though the study by Chang et al 26 showed that patients with a flat pattern audiogram benefited more from hearing aids compared with those with rising or decreasing audiogram in terms of improvement of psychological handicap and quality of life. The present result is likely to be due to tinnitus characteristics together with their associated hearing status.…”

Treatment fidelity in the Tinnitus Retraining Therapy Trial

“…The TRTT protocol has been previously described [9]. Briefly, we assessed the efficacy of TRT and its component parts, TC and ST, compared with SOC in habituating the perceived magnitude, perception, and negative emotional reactions to tinnitus.…”

“…Steps we implemented to address adherence design included engagement of experts to develop standardized protocols, development of checklists, and decisions regarding the number of audiologists and how they were expected to administer treatment within the trial. The TRTT engaged two audiologic experts, one each in TC [9] and SOC [10], to develop the protocols for counseling in the TRTT and serve as protocol monitors. The protocol monitors developed the protocol, trained audiologists, and monitored the quality of the administration of counseling sessions.…”