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Bimodal Therapy for Chronic Subjective Tinnitus: A Randomized Controlled Trial of EMDR and TRT Versus CBT and TRT.

ABSTRACT: Introduction:To date, guidelines recommend the use of a stepped care approach to treat tinnitus. The current clinical management of tinnitus frequently consists of audiologic interventions and tinnitus retraining therapy (TRT) or cognitive behavioral therapy (CBT). Due to the high heterogeneity of the tinnitus population and comorbidity of tinnitus with insomnia, anxiety, and depression, these interventions may not be sufficient for every patient. The current study aims to determine whether a bimodal therapy for chronic, subjective tinnitus consisting of the combination of TRT and eye movement desensitization reprocessing (EMDR) results in a clinically significant different efficacy in comparison with the prevailing bimodal TRT and CBT therapy. Methods:Patients were randomized in two treatment groups. The experimental group received the bimodal therapy TRT/EMDR and the active control group received the bimodal therapy TRT/CBT. Evaluations took place at baseline (T0), at the end of the treatment (T1), and 3 months after therapy (T2). The tinnitus functional index (TFI) was used as primary outcome measurement. Secondary outcome measurements were the visual analog scale of tinnitus loudness (VASLoudness), tinnitus questionnaire (TQ), hospital anxiety and depression scale (HADS), hyperacusis questionnaire (HQ), global perceived effect (GPE), and psychoacoustic measurements. Findings:The TFI showed clinically significant improvement in both bimodal therapies (mean decrease 15.1 in TRT/CBT; p < 0.001 vs. 16.2 in TRT/EMDR; p < 0.001). The total score on the TQ, HADS, HQ, and VASLoudness all demonstrated significant decrease after treatment and follow-up (p < 0.001) in the experimental and the active control group. GPE-measurements revealed that more than 80% (i.e., 84% in TRT/CBT vs. 80% in TRT/EMDR) of the patients experienced substantial improvement of tinnitus at follow up. Treatment outcome remained stable after 3 month follow-up and no adverse events were observed. Conclusion:Both psychotherapeutic protocols result in a clinically significant improvement for patients with chronic subjective tinnitus. No significant different efficacy was found for the TRT/EMDR treatment compared to the combination of TRT and CBT. Clinical Trial registration:ClinicalTrials.gov, ID: NCT03114878. April 14, 2017.

SUBMITTER: Luyten TR

PROVIDER: S-EPMC7511540 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Bimodal Therapy for Chronic Subjective Tinnitus: A Randomized Controlled Trial of EMDR and TRT Versus CBT and TRT.

Luyten Tine Roanna TR Jacquemin Laure L Van Looveren Nancy N Declau Frank F Fransen Erik E Cardon Emilie E De Bodt Marc M Topsakal Vedat V Van de Heyning Paul P Van Rompaey Vincent V Gilles Annick A

Frontiers in psychology 20200910

<h4>Introduction</h4>To date, guidelines recommend the use of a stepped care approach to treat tinnitus. The current clinical management of tinnitus frequently consists of audiologic interventions and tinnitus retraining therapy (TRT) or cognitive behavioral therapy (CBT). Due to the high heterogeneity of the tinnitus population and comorbidity of tinnitus with insomnia, anxiety, and depression, these interventions may not be sufficient for every patient. The current study aims to determine whet ...[more]

PMID: 33013517

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Project description:More than 10% of the population suffers from tinnitus, which is a phantom auditory condition that is coded within the brain. A new neuromodulation approach to treat tinnitus has emerged that combines sound with electrical stimulation of somatosensory pathways, supported by multiple animal studies demonstrating that bimodal stimulation can elicit extensive neural plasticity within the auditory brain. More recently, in a large-scale clinical trial, bimodal neuromodulation combining sound and tongue stimulation drove significant reductions in tinnitus symptom severity during the first 6 weeks of treatment, followed by diminishing improvements during the second 6 weeks of treatment. The primary objective of the large-scale randomized and double-blinded study presented in this paper was to determine if background wideband noise as used in the previous clinical trial was necessary for bimodal treatment efficacy. An additional objective was to determine if adjusting the parameter settings after 6 weeks of treatment could overcome treatment habituation effects observed in the previous study. The primary endpoint at 6-weeks involved within-arm and between-arm comparisons for two treatment arms with different bimodal neuromodulation settings based on two widely used and validated outcome instruments, Tinnitus Handicap Inventory and Tinnitus Functional Index. Both treatment arms exhibited a statistically significant reduction in tinnitus symptoms during the first 6-weeks, which was further reduced significantly during the second 6-weeks by changing the parameter settings (Cohen's d effect size for full treatment period per arm and outcome measure ranged from - 0.7 to - 1.4). There were no significant differences between arms, in which tongue stimulation combined with only pure tones and without background wideband noise was sufficient to reduce tinnitus symptoms. These therapeutic effects were sustained up to 12 months after the treatment ended. The study included two additional exploratory arms, including one arm that presented only sound stimuli during the first 6 weeks of treatment and bimodal stimulation in the second 6 weeks of treatment. This arm revealed the criticality of combining tongue stimulation with sound for treatment efficacy. Overall, there were no treatment-related serious adverse events and a high compliance rate (83.8%) with 70.3% of participants indicating benefit. The discovery that adjusting stimulation parameters overcomes previously observed treatment habituation can be used to drive greater therapeutic effects and opens up new opportunities for optimizing stimuli and enhancing clinical outcomes for tinnitus patients with bimodal neuromodulation.

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.

Project description:ObjectiveThis study aimed to understand the demographics, clinical characteristics, and psychoacoustic status of subjective tinnitus patients to explore the factors associated with acute and chronic tinnitus in the general hospitals of Shanghai.MethodsA cross-sectional study was conducted to investigate the clinical characteristics and psychoacoustic status of subjective tinnitus patients with history greater than 1 month. Data were collected during January 2021 and January 2022 from eight general hospitals in five districts of Shanghai, China. All patients accepted questionnaires and acoustic examination, then SPSS 22.0 and GraphPad Prism 8.0.2 were applied for data analysis.ResultsAmong the 359 tinnitus patients, 126 cases were diagnosed with acute tinnitus, 58 cases were subacute tinnitus, and 175 cases were chronic tinnitus. Patients with acute and chronic tinnitus differed in terms of side of tinnitus, hearing loss, frequency of tinnitus, severity of tinnitus, anxiety, depression, and sleep status. Different characteristics were included in the multivariate ordinal logistic regression analysis. Persistent tinnitus (OR = 2.00, p = .008), high frequency hearing loss (OR = 4.77, p < .001), depression (OR = 1.23, p < .001) were found to be positively associated with the course of tinnitus. Unilateral tinnitus (OR = 0.48, p = .003), mild (OR = 0.29, p = .001) and moderate (OR = 0.46, p = .038) hearing loss, VAS scores (OR = 0.82, p = .032), anxiety (OR = 0.81, p < .001), THI scores (OR = 0.98, p = .002), and sleep disorders (OR = 0.94, p = .025) were found to be negatively associated with the course of tinnitus.ConclusionPatients with acute tinnitus were at greater risk for anxiety, sleep disturbances, and exacerbation of tinnitus perception, and those with chronic tinnitus were at greater risk for depression.Lay summaryOur study demonstrated that patients with acute tinnitus were at greater risk for anxiety, sleep disturbances, and exacerbation of tinnitus perception, and those with chronic tinnitus were at greater risk for depression.

Dataset Information

Bimodal Therapy for Chronic Subjective Tinnitus: A Randomized Controlled Trial of EMDR and TRT Versus CBT and TRT.

Publications

Bimodal Therapy for Chronic Subjective Tinnitus: A Randomized Controlled Trial of EMDR and TRT Versus CBT and TRT.

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