Treatment fidelity in the Tinnitus Retraining Therapy Trial.

BACKGROUND: Treatment fidelity, defined as ensuring that the recipient receives the intended intervention, is a critical component for accurate estimation of treatment efficacy. Ensuring fidelity and protocol adherence in behavioral trials requires careful planning during the design phase and implementation during the trial. The Tinnitus Retraining Therapy Trial (TRTT) randomized individuals with severe tinnitus to tinnitus retraining therapy (TRT, comprised of tinnitus-specific educational counseling (TC) and sound therapy (ST) using conventional sound generators (SGs)); Partial TRT (TC and placebo SGs); or standard of care (SOC), using a patient-centered care approach. Study audiologists administered both types of counseling in the TRTT, creating a challenge for managing protocol adherence. METHODS: We developed methods to enhance treatment fidelity including training, competency assessment, scripts, visual aids, and fidelity monitoring. Protocol monitors identified critical topics and content to be addressed for each type of counseling session, prepared corresponding scripts, and developed training aids and treatment-specific checklists covering those topics. Study audiologists' competency assessment required submission and review by the protocol monitors of an audiotape of one TC and one SOC counseling session. Treatment-specific aids included scripts, a 3-D model of the ear, handouts, and for TC, an illustrated flip-chart with talking points that followed the scripted content. During the trial, audiologists completed treatment-specific checklists during each counseling session, indicating topics covered/discussed and submitted audiotapes of counseling sessions. Protocol monitors reviewed audiotapes using corresponding treatment-specific checklists. Results for individual checklist items were tabulated and proportions calculated. RESULTS: Twenty-five audiologists were certified for TC and/or SOC counseling and 24 completed at least one counseling session. Adherence to each of 33 critical items on the TC checklist as assessed by the protocol monitor ranged from 70 to 100% across 37 counseling sessions (median 97%), with no difference between adherence for TRT (median, 97%) and partial TRT (median, 100%). Adherence to each of 44 critical items on the SOC checklist across 30 SOC counseling sessions ranged from 42 to 100% (median, 87.5%). CONCLUSION: The TRTT used multiple methods to address treatment fidelity. The close adherence to each treatment type was critical for evaluating the efficacy of the study interventions in this randomized trial. TRIAL REGISTRATION: clinicaltrials.gov NCT01177137 . Registered on 5 August 2010.

The Tinnitus Retraining Therapy Trial's Standard of Care Control Condition: Rationale and Description of a Patient-Centered Protocol.

Purpose The selection and design of control conditions are critical factors in minimizing the influence of unwanted variables in randomized controlled trials (RCTs). This article describes the rationale, design, and content of a standard of care control condition in a Phase III RCT of tinnitus retraining therapy. Method Existing tinnitus practices at military hospitals were identified and aligned with the American Speech-Language-Hearing Association's (2006) preferred practice patterns for tinnitus management and counseling and embedded in a patient-centered protocol to ensure uniformity and treatment fidelity. Results For those involved in the design of behavioral RCTs, the article identifies options and methods to consider in the selection and design of control conditions. Conclusion For those who provide tinnitus services, the standard of care protocol developed for the tinnitus retraining therapy trial constitutes a patient-centered approach to intervention that can be implemented clinically. Supplemental Material https://doi.org/10.23641/asha.9342503.

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

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/DESIGN: 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. TRIAL REGISTRATION: Clinicaltrials.gov NCT01177137.

Development of the screening test for hearing problems.

PURPOSE: The goal of this study was to develop a brief self-assessment instrument to screen for communication problems and psychosocial adjustment to hearing impairment as part of a rehabilitative needs assessment. METHOD: A pseudorandom sample of 1,000 cases was drawn from a large, heterogeneous clinical database containing audiometric data and responses to the Communication Profile for the Hearing Impaired (CPHI; Erdman & Demorest, 1998a). Item response theory was used to derive item-characteristic curves, and item selection was based primarily on item discrimination. Internal consistency, factor structure, sensitivity, and specificity of 2 scales, Communication and Adjustment, were evaluated in a holdout sample of 319 cases from the same database. RESULTS: A 9-item Communication scale and an 11-item Adjustment scale both showed satisfactory internal consistency, and the 20-item test presented a clear 2-factor structure. Sensitivity and specificity functions and positive and negative predictive values indicated that the 2 scales could be used to identify the bottom 2 quartiles of the clinical population, as defined by factor scores on the CPHI. CONCLUSION: The 2 scales of the Screening Test for Hearing Problems can be used to screen for communication and adjustment problems that warrant a comprehensive rehabilitative assessment.

Psychosocial correlates of hearing aid adjustment.

Despite considerable evidence regarding the detrimental effects of untreated hearing loss, there continues to be an underutilization of hearing aids by adults. The Long Term Follow-Up of Patients in the National Institute on Deafness and Other Communication Disorders/Veterans Affairs (NIDCD/VA) Hearing Aid Clinical Trial (Cooperative Studies Program [CSP] 418-A) provided the opportunity to compare a number of potential psychosocial influences and outcomes for hearing aid users and nonusers from the original CSP 418 study. The Communication Profile for the Hearing Impaired (CPHI) results provide compelling evidence of hearing aid benefit. Mean Communication Performance (CP) scores for hearing aid users on the Social, Work, and Home scales improved significantly from the original CSP 418 administration. For nonusers, there were no significant CPHI changes from the previous administration. Although hearing aid users and nonusers did not differ in optimism, this parameter was correlated with personal adjustment, measured via the CPHI. Hearing aid use was associated with the perception of major life events, such as illness, retirement, and so forth.