title: The Tinnitus Retraining Therapy Trial (TRTT): study protocol for a randomized controlled trial.
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
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01177137.
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. rschere1@jhu.edu.
authors.forename: Roberta W
authors.initials: RW
authors.lastname: Scherer
authors.forename: Craig
authors.initials: C
authors.lastname: Formby
authors.forename: Susan
authors.initials: S
authors.lastname: Gold
authors.forename: Sue
authors.initials: S
authors.lastname: Erdman
authors.forename: Charles
authors.initials: C
authors.lastname: Rodhe
authors.forename: Michele
authors.initials: M
authors.lastname: Carlson
authors.forename: Dave
authors.initials: D
authors.lastname: Shade
authors.forename: Melanie
authors.initials: M
authors.lastname: Tucker
authors.forename: Lee McCaffrey
authors.initials: LM
authors.lastname: Sensinger
authors.forename: Gordon
authors.initials: G
authors.lastname: Hughes
authors.forename: George S
authors.initials: GS
authors.lastname: Conley
authors.forename: Naomi
authors.initials: N
authors.lastname: Downey
authors.forename: Cynthia
authors.initials: C
authors.lastname: Eades
authors.forename: Margaret
authors.initials: M
authors.lastname: Jylkka
authors.forename: Ada
authors.initials: A
authors.lastname: Haber-Perez
authors.forename: Courtney
authors.initials: C
authors.lastname: Harper
authors.forename: Shoshannah Kantor
authors.initials: SK
authors.lastname: Russell
authors.forename: Benigno
authors.initials: B
authors.lastname: Sierra-Irizarry
authors.forename: Mark
authors.initials: M
authors.lastname: Sullivan
mesh_terms: D000161:Acoustic Stimulation / Q000379:methods*; D000223:Adaptation, Psychological; D001306:Auditory Pathways / Q000503:physiopathology; D001307:Auditory Perception; D002985:Clinical Protocols; D003376:Counseling; D004185:Disability Evaluation; D004311:Double-Blind Method; D006185:Habituation, Psychophysiologic; D006309:Hearing; D006801:Humans; D008889:Military Personnel; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D013016:Sound; D011795:Surveys and Questionnaires; D013997:Time Factors; D014012:Tinnitus / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome; D014481:United States