The Tinnitus Retraining Therapy Trial (TRTT) is a five-year study designed to investigate the efficacy of tinnitus retraining therapy (TRT) and its component parts, directive counseling (DC) and sound therapy (ST). The TRTT is a multi-center placebo-controlled randomized trial, enrolling individuals with subjective debilitating tinnitus to one of 3 treatment groups: (1) DC and ST achieved with conventional noise generators (NG);(2) DC and placebo NG;(3) Standard-of-care (SC) as usually administered in the military. We will enroll 76 participants per group using a treatment allocation ratio of 1:1:1 for a total of 228 participants. A standardized protocol for treatment and data collection will be used by all centers. The primary outcome is change in Tinnitus Questionnaire (TQ) score assessed longitudinally at follow-up, taking place at 3, 6, 12, and 18 months following the initial treatment session. Secondary outcomes include change in TQ sub-scores, in Tinnitus Handicap Inventory and Tinnitus Reaction Questionnaire scores, and in the visual analogue scale of the TRT Interview. Other secondary outcomes include audiometric measures, psychoacoustic measures, and change in quality of life. The primary objective of the study is to evaluate the efficacy of TRT (DC and conventional NG) compared with SC. The secondary objectives are to evaluate (1) the efficacy of DC plus placebo NG versus SC, and (2) the efficacy of conventional versus placebo NG in study participants assigned to DC. We hypothesize that (1) full TRT will be more efficacious than SC, (2) DC + placebo NG will be more efficacious than SC , and (3) conventional NG will be more efficacious than placebo NG, in habituating the tinnitus awareness, annoyance, and impact on the study participant's life. Study centers will include a Study Chair's Office, Data Coordination Center, and 6 Clinical Centers, which offer a rich and diverse population for the study of primary tinnitus in the TRTT.
Tinnitus is the perception of sound in the absence of a corresponding external sound, and for which there is no apparent cause. While most individuals with tinnitus require no professional help, as many as 5 million Americans suffer disabling tinnitus with resulting impairment of well being and an inability to lead a normal lifestyle. To address this disability, the Tinnitus Retraining Therapy Trial will test the efficacy of tinnitus retraining therapy, a habituation-based intervention that uses directive counseling and low-level sound therapy to reduce the negative emotional reactions and the perception of the tinnitus in individuals with debilitating tinnitus, resulting in improved quality of life.
|Scherer, Roberta W; Formby, Craig; Gold, Susan et al. (2014) The Tinnitus Retraining Therapy Trial (TRTT): study protocol for a randomized controlled trial. Trials 15:396|
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