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

ABSTRACT: 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.

SUBMITTER: Scherer RW

PROVIDER: S-EPMC4210573 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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

Scherer Roberta W RW Formby Craig C Gold Susan S Erdman Sue S Rodhe Charles C Carlson Michele M Shade Dave D Tucker Melanie M Sensinger Lee McCaffrey LM Hughes Gordon G Conley George S GS Downey Naomi N Eades Cynthia C Jylkka Margaret M Haber-Perez Ada A Harper Courtney C Russell Shoshannah Kantor SK Sierra-Irizarry Benigno B Sullivan Mark M

Trials 20141015

<h4>Background</h4>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-speci ...[more]

PMID: 25319676

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Project description:BackgroundTreatment 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.MethodsWe 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.ResultsTwenty-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%).ConclusionThe 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 registrationclinicaltrials.gov NCT01177137 . Registered on 5 August 2010.

Project description:ImportanceTinnitus retraining therapy (TRT) is an internationally recognized, but controversial, protocol of uncertain efficacy that uses tinnitus-specific educational counseling (TC) and sound therapy (ST) to reduce the patient's tinnitus-evoked negative reaction to, and awareness of, tinnitus.ObjectiveTo compare the efficacy of TRT and its components, ST and TC, with the standard of care (SoC) in reducing the negative effect of tinnitus on quality of life.Design, setting, and participantsA randomized, placebo-controlled, multicenter phase 3 trial was conducted from August 4, 2011, to June 20, 2017, at 6 US military hospitals, the study chairs' office, and a data coordinating center, among 151 active-duty and retired military personnel and dependents with functionally adequate hearing sensitivity and moderate to severe subjective tinnitus. All analyses were based on intention to treat.InterventionsCentral randomized allocation to TRT (TC and ST with conventional sound generators), partial TRT (TC with placebo sound generators), or SoC.Main outcomes and measuresThe primary outcome was mean change on the Tinnitus Questionnaire (TQ), assessed longitudinally between baseline and 18 months after start of therapy. The secondary outcomes were changes in TQ subscales, Tinnitus Functional Index (TFI), and Tinnitus Handicap Inventory (THI) total and subscales, as well as a 10-point visual analog scale (VAS).ResultsAmong the 151 participants in the study (44 women and 107 men; mean [SD] age, 50.6 [11.3] years), 51 were randomized to receive TRT, 51 to receive partial TRT, and 49 to receive standard of care. Longitudinal analyses showed no difference between partial TRT or TRT compared with SoC, or partial TRT compared with TRT, on TQ, TFI, or THI total scores. Comparison of changes in mean score from baseline to the 18-month visit also showed no difference between treatment groups. Significant improvement was observed at 18 months in all treatment groups on TQ scores for TRT (effect size, -1.32; 95% CI, -1.78 to -0.85), partial TRT (effect size, -1.16; 95% CI, -1.56 to -0.76), and SoC (effect size, -1.01; 95% CI, -1.41 to -0.61). Compared with baseline scores, at 18 months there were reductions in scores by 7 points or more on the TQ score for 86 of 111 participants (77.55%; 95% CI, 69.7%-85.2%), 13 points or more on the TFI for 52 of 111 participants (46.8%; 95% CI, 37.6%-56.1%), 7 points or more on the THI for 63 of 111 participants (56.8%; 95% CI, 47.5%-66.0%), and 2 points or more on the VAS for 45 of 93 participants (48.4%; 95% CI, 38.2%-58.5%).Conclusions and relevanceThere were few differences between treatment groups. About half of participants showed clinically meaningful reductions in the effect of tinnitus.Trial registrationClinicalTrials.gov identifier: NCT01177137.

Project description:Tinnitus occurs in a large part of the general population with prevalences ranging from 10% to 15% in an adult population. One subtype is cervicogenic somatic tinnitus, arising from cervical spine dysfunctions, justifying cervical spine assessment and treatment. This study aims to investigate the effect of a standardized physical therapy treatment, directed to the cervical spine, on tinnitus. Additionally, a second aim is to identify a subgroup within the tinnitus population that benefits from physical therapy treatment.This study is designed as a randomized controlled trial with delayed treatment design. Patients with severe subjective tinnitus (Tinnitus Functional Index (TFI) between 25 and 90 points), in combination with neck complaints (Neck Bournemouth Questionnaire (NBQ) >14 points) will be recruited from the University Hospital of Antwerp. Patients suffering from tinnitus with clear otological etiologies, severe depression, traumatic cervical spine injury, tumors, cervical spine surgery, or conditions in which physical therapy is contra-indicated, will be excluded.After screening for eligibility, baseline data such as TFI, NBQ, and a set of cervical biomechanical and sensorimotor tests will be collected. Patients are randomized in an immediate therapy group and in a group with a delayed start of therapy by 6 weeks. Patients will receive physical therapy with a maximum of 12 sessions of 30 min for a 6-week program. Data from the TFI and NBQ will be collected at baseline (week 0), at the start of therapy (weeks 0 or 6), at the end of therapy (weeks 6 or 12), 6 weeks after therapy (weeks 12 or 18), and 3 months after therapy (weeks 18 or 24). Secondary outcome measures will be collected at baseline and 6 weeks after the therapy (weeks 12 or 18), as the maximal therapy effect on the cervical spine dysfunctions is expected at that moment.This study is the first to investigate the effect of a standardized physical therapy treatment protocol on somatic tinnitus with a prospective comparative delayed design and with blinded evaluator for baseline, end of therapy, and 6 and 12 weeks after therapy.12 September 2013, ClinicalTrials.gov: NCT02016313.

Project description:Background The Tinnitus Retraining Therapy Trial (TRTT), a randomized, placebo-controlled, multi-center trial, evaluated the efficacy of tinnitus retraining therapy and its individual components, tinnitus-specific educational counseling and sound therapy versus the standard of care, in military practice to improve study participants' quality of life. The trial was conducted at six US military hospitals to take advantage of the greater prevalence of tinnitus in the military population. Methods During the trial, various challenges arose that were uniquely related to the military setting. To convey these challenges to investigators planning future multi-center trials in military hospitals, we itemized various challenges that arose during the trial, interviewed clinic directors and coordinators to elicit their viewpoints, and then collated and organized their responses, together with those challenges presented while conducting the Tinnitus Retraining Therapy Trial. Results We encountered challenges in site selection, the approval process, administrative issues, study personnel training and retention, participant recruitment methods and issues, adherence to protocol, reimbursement issues, and military security. Site selection involved visiting 20 military hospitals to identify six sites that enrolled and followed study participants. We found that commitment for the trial must be obtained from the full military chain of command, but with ongoing changes in staff or military priorities, initial commitments were insufficient to sustain support throughout the entire trial. More time is required to obtain necessary administrative approvals by various military authorities and institutional review boards than is typically experienced in civilian settings. Recruitment strategies must be flexible due to changing military regulations regarding display of materials. Protracted periods of inactivity were due to sequestration and delays in institutional review board approval of required study personnel or protocol amendments. While mostly adherent to the protocol, study staff had difficulties in integrating study visits into the military clinical schedule. Unexpected study expenses revolved around hiring civilian study staff and obtaining associated security clearance while maintaining a consistent flow of funds to each site. The added expense negated cost savings realized by conducting the National Institutes of Health-funded trial at federal institutions, whose personnel could not be reimbursed for their efforts. Military security concerns impacted the use of web-based data systems and led to increased time and effort required for site visits. Conclusion Overall, US military hospitals provide a unique setting to conduct multi-center trials. Challenges arise mainly due to ever-changing authority personnel and military priorities. Pre-planning and flexibility are keys in overcoming these challenges. Multi-center trials conducted in the military will likely take longer to initiate and complete than those in the civilian sector due to multiple levels of command and administrative approvals.

Project description:BackgroundCurrent theories of tinnitus assume that the phantom sound is generated either through increased spontaneous activity of neurons in the auditory brain, or through pathological temporal firing patterns of the spontaneous neuronal discharge, or a combination of both factors. With this in mind, Tass and colleagues recently tested a number of temporally patterned acoustic stimulation strategies in a proof of concept study. Potential therapeutic sound regimes were derived according to a paradigm assumed to disrupt hypersynchronous neuronal activity, and promote plasticity mechanisms that stabilize a state of asynchronous spontaneous activity. This would correspond to a permanent reduction of tinnitus. The proof of concept study, conducted in Germany, confirmed the safety of the acoustic stimuli for use in tinnitus, and exploratory results indicated modulation of tinnitus-related pathological synchronous activity with potential therapeutic benefit. The most effective stimulation paradigm is now in clinical use as a sound therapy device, the acoustic coordinated reset (CR®) neuromodulation (Adaptive Neuromodulation GmbH (ANM), Köln, Germany).Methods/designTo measure the efficacy of CR® neuromodulation, we devised a powered, two-center, randomized controlled trial (RCT) compliant with the reporting standards defined in the Consolidated Standards of Reporting Trials (CONSORT) Statement. The RCT design also addresses the recent call for international standards within the tinnitus community for high-quality clinical trials. The design uses a between-subjects comparison with minimized allocation of participants to treatment and placebo groups. A minimization approach was selected to ensure that the two groups are balanced with respect to age, gender, hearing, and baseline tinnitus severity. The protocol ensures double blinding, with crossover of the placebo group to receive the proprietary intervention after 12 weeks. The primary endpoints are the pre- and post-treatment measures that provide the primary measures of efficacy, namely a validated and sensitive questionnaire measure of the functional impact of tinnitus. The trial is also designed to capture secondary changes in tinnitus handicap, quality (pitch, loudness, bandwidth), and changes in tinnitus-related pathological synchronous brain activity using electroencephalography (EEG).DiscussionThis RCT was designed to provide a confident high-level estimate of the efficacy of sound therapy using CR® neuromodulation compared to a well-matched placebo intervention, and uniquely in terms of sound therapy, examine the physiological effects of the intervention against its putative mechanism of action.Trial registrationClinicalTrials.gov, NCT01541969.

Project description:BackgroundTinnitus is a symptom that can be very distressing owing to hearing sounds not related to any external sound source. Managing tinnitus is notoriously difficult, and access to evidence-based care is limited. Cognitive behavioral therapy (CBT) is a tinnitus management strategy with the most evidence of effectiveness but is rarely offered to those distressed by tinnitus. The provision of internet-based CBT for tinnitus overcomes accessibility barriers; however, it is not currently readily available in the United States.ObjectiveThe aim of this study is to investigate the efficacy of internet-based CBT compared with that of weekly monitoring for the management of tinnitus in reducing tinnitus distress; reducing tinnitus-related comorbidities, including tinnitus cognitions, insomnia, anxiety, and depression; and assessing the stability of the intervention effects 2 months after the intervention.MethodsA 2-arm randomized clinical trial comparing audiologist-guided internet-based CBT (n=79) to a weekly monitoring group (n=79) with a 2-month follow-up assessed the efficacy of internet-based CBT. Eligible participants included adults seeking help for tinnitus. Recruitment was conducted on the web using an open-access website. Participants were randomized via 1:1 allocation, but blinding was not possible. The study was undertaken by English or Spanish speakers on the web. The primary outcome was a change in tinnitus distress as measured using the Tinnitus Functional Index. Secondary outcome measures included anxiety, depression, insomnia, tinnitus cognition, hearing-related difficulties, and quality of life.ResultsInternet-based CBT led to a greater reduction in tinnitus distress (mean 36.57, SD 22) compared with that in weekly monitoring (mean 46.31, SD 20.63; effect size: Cohen d=0.46, 95% CI 0.14-0.77) using an intention-to-treat analysis. For the secondary outcomes, there was a greater reduction in negative tinnitus cognition and insomnia. The results remained stable over the 2-month follow-up period. No important adverse events were observed. Further, 16% (10/158) of participants withdrew, with low overall compliance rates for questionnaire completion of 72.3% (107/148) at T1, 61% (91/148) at T2, and 42% (62/148) at T3.ConclusionsThis study is the first to evaluate and indicate the efficacy of audiologist-delivered internet-based CBT in reducing tinnitus distress in a US population. It was also the first study to offer internet-based CBT in Spanish to accommodate the large Hispanic population in the United States. The results have been encouraging, and further work is indicated in view of making such an intervention applicable to a wider population. Further work is required to improve compliance and attract more Spanish speakers.Trial registrationClinicalTrials.gov NCT04004260; https://clinicaltrials.gov/ct2/show/NCT04004260.

Project description:IntroductionChronic subjective tinnitus has become an increasingly serious hazard that affects the health-related quality of life for millions of people. Due to the lack of curative treatment strategies, this study aims to introduce a novel acoustic therapy named the modified tinnitus relieving sound (MTRS) for tinnitus and to evaluate the efficacy of MTRS in comparison with unmodified music (UM) which served as a control.Methods and analysisA randomized, double-blinded, controlled, clinical trial will be carried out. Sixty-eight patients with subjective tinnitus will be recruited and randomly allocated into two groups in 1:1 ratio. The primary outcome is Tinnitus Handicapped Inventory (THI); the secondary outcomes are the Hospital Anxiety and Distress Scale (HADS; HADS subscales for Anxiety (HADS-A) and Depression (HADS-D)), Athens Insomnia Scale (AIS), the visual analog scale (VAS) for tinnitus, and tinnitus loudness matched by sensation level (SL). Assessment will be performed at baseline and at 1, 3, 9, and 12 months post-randomization. The sound stimulus will be persistent until 9 months after randomization, and be interdictory in the last three months. Data collected during the intervention process will be analyzed and compared to baseline.Ethics and disseminationThis trial received ethical approval from the Institutional Review Board (IRB) of Eye & ENT Hospital of Fudan University (No. 2017048). The study results will be disseminated via academic journals and conferences.FundingThis study is supported by the Shanghai Shenkang Development Program (SHDC12019119), the Excellent Doctors-Excellent Clinical Researchers Program (SYB202008), the Shanghai Rising-Star Program (23QC1401200), the Shanghai Rising Stars of Medical Talent Youth Development Program (2021-99), the National Natural Science Foundation of China (81800912), and the National Natural Science Foundation of Shanghai (21ZR1411800).Trial registrationClinicalTrials.gov NCT04026932. Registered on 18 July 2019.

Dataset Information

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

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

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