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

Erdman, Sue Ann; Scherer, Roberta W.; Sierra-Irizarry, Benigno; Formby, C.

doi:10.1044/2019_aja-18-0068

Cited by 4 publications

(9 citation statements)

References 87 publications

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“…Steps we implemented to address adherence design included engagement of experts to develop standardized protocols, development of checklists, and decisions regarding the number of audiologists and how they were expected to administer treatment within the trial. The TRTT engaged two audiologic experts, one each in TC [9] and SOC [10], to develop the protocols for counseling in the TRTT and serve as protocol monitors. The protocol monitors developed the protocol, trained audiologists, and monitored the quality of the administration of counseling sessions.…”

Section: Design Of Steps For Adherencementioning

confidence: 99%

“…To achieve consistency across clinical sites, each protocol monitor first identified critical topics for each type of counseling session. This effort included survey of the existing care for tinnitus patients at each site preliminary to establishing the TC protocol [10]. These critical steps were incorporated into a written protocol that became a chapter within the TRTT Manual of Procedures.…”

Section: Design Of Steps For Adherencementioning

confidence: 99%

“…Allowances were made within the scripts for personal counselor style or variation, keeping critical elements intact. These protocols, described in detail elsewhere [9,10], were considered crucial for the successful standardized management of tinnitus within each arm of the trial across the six participating military clinical centers in the TRTT.…”

Section: Design Of Steps For Adherencementioning

confidence: 99%

“…To begin development of the protocol for each type of counseling, protocol monitors began by identifying critical topics for each type of counseling session. They then incorporated these topics into scripts and used them to develop checklists covering those topics, keeping in mind the site survey results describing the typical care at the military sites [10]. Because some topics were critical for both TC and SOC counseling sessions (e.g., how we hear), it was important to ensure that the scripts and associated talking points were linked to the visual aids developed for use for each type of counseling.…”

Section: Deliverymentioning

confidence: 99%

“…The TRTT also evaluated the necessity for the use of SGs by including a third study arm, the Partial TRT group, which used TC and short-acting placebo SGs as a control for ST. The SOC group received counseling that used an interactive patient-centered care approach focusing on assisting the study patient to become actively engaged in his or her symptom relief [10]. All three study groups were encouraged to use environmental sound at all times.…”

Section: Introductionmentioning

confidence: 99%

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Treatment fidelity in the Tinnitus Retraining Therapy Trial

Scherer

Erdman²,

Gold

et al. 2020

Trials

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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 treatmentspecific 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.

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Section: Design Of Steps For Adherencementioning

confidence: 99%

Section: Design Of Steps For Adherencementioning

confidence: 99%

Section: Design Of Steps For Adherencementioning

confidence: 99%

Section: Deliverymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Treatment fidelity in the Tinnitus Retraining Therapy Trial

Scherer

Erdman²,

Gold

et al. 2020

Trials

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The Tinnitus Retraining Therapy Counseling Protocol as Implemented in the Tinnitus Retraining Therapy Trial

2021

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Purpose This clinical focus article is a companion to the work of Erdman et al. (2019), in which we described the rationale, development, and implementation of the standard-of-care protocol used in the Tinnitus Retraining Therapy Trial (TRTT), a multicenter, placebo-controlled, randomized, definitive efficacy trial of tinnitus retraining therapy (TRT). We now describe the historical background, development, and standardized implementation and delivery of the TRT counseling protocol (tinnitus counseling [TC]) used in the TRTT. TC is conjectured to be the key component in the TRT protocol for initiating the habituation process that reduces the response to the tinnitus signal and, ultimately, reduces its impact. In the TRTT, participants assigned to receive TC achieved > 30% reduction in the impact of tinnitus. Method and Results The design and implementation of standardized treatments in multisite randomized controlled trials presents many challenges for investigators. Here, subsequent to presenting the background, rationale, and the TRT protocol model, we describe the development, refinement, and training/certification for standardized delivery of TC in the TRTT. The primary challenges encountered while distilling and streamlining TC for standardized delivery across multiple clinicians and their replacements at six participating military treatment centers in the TRTT are considered, and the resulting counseling protocol is detailed. Conclusions The standardized and streamlined TC used in the TRTT was successful for treating debilitating tinnitus among persons with functionally adequate unaided hearing sensitivity. The structured TC protocol described here appears to be the main determinant of the significant and sizable TRT treatment effects measured in the TRTT, thus bolstering the merits of this standardized counseling approach as one model for the clinical implementation of TRT for the treatment of primary tinnitus.

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Contributions of Counseling and Sound Generator Use in Tinnitus Retraining Therapy: Treatment Response Dynamics Assessed in a Secondary Analysis of a Randomized Trial

Formby

Yang

Scherer

2022

J Speech Lang Hear Res

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Purpose: Tinnitus retraining therapy (TRT) has been widely used for 30 years, but its efficacy and the component contributions from counseling and sound therapy remain controversial. The purpose of this secondary analysis from the Tinnitus Retraining Therapy Trial (TRTT) was to compare treatment response dynamics for TRT (counseling and conventional sound generators) with partial TRT (pTRT; counseling and placebo sound generators) and standard of care (SOC; a patient-centered counseling control). Method: The TRTT randomized 151 participants with primary tinnitus ( no significant hearing or sound tolerance problems ) to TRT, pTRT, or SOC, each of which encouraged use of enriched environmental sound. The primary outcome, mean change in Tinnitus Questionnaire score assessed at baseline and follow-up across 18 months, was normalized for a common baseline and fitted with an exponential model. Time constants were estimated to quantify and compare the treatment response dynamics, which were evaluated for statistical significance using bootstrap analyses. Results: The change in response to TRT took less time to achieve than that for either pTRT or SOC, as demonstrated by time for normalized Tinnitus Questionnaire scores to decline to 63% and 99% of baseline TRT values: 1.2 months (95% CI [0.2, 1.9]) and 5.7 months (95% CI [0.9, 9.0]), respectively. Corresponding SOC values were 2.7 months (95% CI [1.5, 4.1]) and 12.4 months (95% CI [6.9, 19.0]), while those for pTRT were 2.2 months (95% CI [1.2, 3.4]) and 10.1 months (95% CI [5.7, 15.9]). The differences were significant for TRT versus SOC ( p = .020), borderline significant for TRT versus pTRT ( p = .057), but nonsignificant for pTRT versus SOC ( p = .285). The magnitude of the asymptotic treatment response did not differ significantly among groups. Conclusion: Sound generator use in TRT increases treatment efficiency (beyond any advantage from enriched environmental sound) without affecting treatment efficacy (determined by counseling).

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

Cited by 4 publications

References 87 publications

Treatment fidelity in the Tinnitus Retraining Therapy Trial

Treatment fidelity in the Tinnitus Retraining Therapy Trial

The Tinnitus Retraining Therapy Counseling Protocol as Implemented in the Tinnitus Retraining Therapy Trial

Contributions of Counseling and Sound Generator Use in Tinnitus Retraining Therapy: Treatment Response Dynamics Assessed in a Secondary Analysis of a Randomized Trial

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