The Tinnitus Retraining Therapy Counseling Protocol as Implemented in the Tinnitus Retraining Therapy Trial.

Purpose This clinical focus article is a companion to the work of Erdman et al. (2019), in which we described the rationale, development, and implementation of the standard-of-care protocol used in the Tinnitus Retraining Therapy Trial (TRTT), a multicenter, placebo-controlled, randomized, definitive efficacy trial of tinnitus retraining therapy (TRT). We now describe the historical background, development, and standardized implementation and delivery of the TRT counseling protocol (tinnitus counseling [TC]) used in the TRTT. TC is conjectured to be the key component in the TRT protocol for initiating the habituation process that reduces the response to the tinnitus signal and, ultimately, reduces its impact. In the TRTT, participants assigned to receive TC achieved > 30% reduction in the impact of tinnitus. Method and Results The design and implementation of standardized treatments in multisite randomized controlled trials presents many challenges for investigators. Here, subsequent to presenting the background, rationale, and the TRT protocol model, we describe the development, refinement, and training/certification for standardized delivery of TC in the TRTT. The primary challenges encountered while distilling and streamlining TC for standardized delivery across multiple clinicians and their replacements at six participating military treatment centers in the TRTT are considered, and the resulting counseling protocol is detailed. Conclusions The standardized and streamlined TC used in the TRTT was successful for treating debilitating tinnitus among persons with functionally adequate unaided hearing sensitivity. The structured TC protocol described here appears to be the main determinant of the significant and sizable TRT treatment effects measured in the TRTT, thus bolstering the merits of this standardized counseling approach as one model for the clinical implementation of TRT for the treatment of primary tinnitus.