posted on 2019-08-19, 21:19authored bySue Ann Erdman, Roberta W. Scherer, Benigno Sierra-Irizarry, Craig Formby
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 S1. Military audiologists' practices.
Supplemental Material S2. TRTT standard of care handouts.
Erdman, S. A., Scherer, R. W., Sierra-Irizarry, B., & Formby, C. (2019). The Tinnitus Retraining Therapy Trial’s Standard of Care Control Condition: Rationale and Description of a Patient-Centered Protocol. American Journal of Audiology, 28, 534–547. https://doi.org/10.1044/2019_AJA-18-0068
Acknowledgments This study was funded by National Institute on Deafness and Other Communication Disorders Grant U01DC007411 awarded to Craig Formby, Tinnitus Retraining Therapy Trial Study Chair, and Grant U01DC007422 awarded to Roberta W. Scherer, Data Coordinating Center Director.