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

Autor: Roberta W, Scherer, Craig, Formby, Susan, Gold, Sue, Erdman, Charles, Rodhe, Michele, Carlson, Dave, Shade, Melanie, Tucker, Lee McCaffrey, Sensinger, Gordon, Hughes, George S, Conley, Naomi, Downey, Cynthia, Eades, Margaret, Jylkka, Ada, Haber-Perez, Courtney, Harper, Shoshannah Kantor, Russell, Benigno, Sierra-Irizarry, Mark, Sullivan, Jennifer, Schumi
Rok vydání: 2014
Předmět:
Counseling
medicine.medical_specialty
Auditory Pathways
Time Factors
Visual analogue scale
Medicine (miscellaneous)
Severity of Illness Index
Tinnitus retraining therapy
law.invention
Disability Evaluation
Tinnitus
Study Protocol
03 medical and health sciences
0302 clinical medicine
Clinical Protocols
Double-Blind Method
Hearing
Randomized controlled trial
Quality of life
law
Surveys and Questionnaires
Multicenter trial
Adaptation
Psychological
Severity of illness
otorhinolaryngologic diseases
Humans
Medicine
Pharmacology (medical)
Habituation
Psychophysiologic
030223 otorhinolaryngology
business.industry
Beck Depression Inventory
United States
3. Good health
Military Personnel
Sound
Treatment Outcome
Acoustic Stimulation
Research Design
Auditory Perception
Quality of Life
Physical therapy
Randomized clinical trial
medicine.symptom
business
030217 neurology & neurosurgery
Zdroj: Trials
ISSN: 1745-6215
Popis: 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. 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. Clinicaltrials.gov NCT01177137 .
Databáze: OpenAIRE
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