Better Together. Group versus individual Cognitive-Behavioral Therapy for tinnitus: A Multiple-Baseline Single-Case Experimental Design.

OBJECTIVES: Chronic tinnitus is effectively treated through cognitive-behavioral therapy (CBT). Both group and individual CBT for tinnitus are effective, but no study has directly compared the two. The current study explores group versus individual CBT for tinnitus. DESIGN: A multiple-baseline single-case experimental design was employed to observe changes within/between individual and group treatments. Six participants started a 10-week CBT protocol and were equally divided into individual or group treatment. Participants were exchanged between treatments at random time points. Diary data included 14 variables on tinnitus experience (e.g. annoyance and distraction) and wellbeing (e.g. happiness and stress). Five male participants (59- to 67-year-old) completed treatment. RESULTS: Randomization tests comparing means between individual and group treatments did not reveal significant differences. Analysis of data overlap and trend (Tau-U) revealed minor significant improvements for seven variables (50%) in group treatment as compared to individual treatment. Diminished happiness and activity levels were observed in participants who went from group to individual treatment. CONCLUSIONS: Low effect sizes and homogeneity of sample restrict the generalizability of data. Group CBT indicated potential benefits when compared to individual CBT. Social learning may be an underlying process in group delivery boosting tinnitus recovery. Findings are limited to male patients with chronic disabling tinnitus.

Pragmatic Uncontrolled Study of Specialized Cognitive Behavioral Therapy for Adults With Chronic Tinnitus.

OBJECTIVES: Tinnitus is the perception of sound without an external source, affecting quality of life that can cause severe distress in approximately 1 to 3% of the population of people with tinnitus. Randomized controlled trials of cognitive behavioral therapy for tinnitus have demonstrated its effectiveness in improving quality of life, but the effects of their implementation on a large scale in routine practice remains unknown. Therefore, the main purpose of this study was to examine the effects of stepped-care cognitive behavioral therapy for tinnitus delivered in a tertiary audiological center of a regional hospital. Second, we wished to examine predictors of favorable outcome. DESIGN: Four hundred three adults with chronic tinnitus were enrolled in this prospective observational study (at 3 months, N=334, 8 months, N=261; 12 months, N=214). The primary outcome was health-related quality of life as measured by the Health Utilities Index III (HUI-III) at 12 months. Secondary outcomes were self-reported levels of tinnitus-related distress, disability, affective distress and tinnitus-related negative beliefs and fear. Measures were completed pre-intervention at 3 months, 8 months, and 12 months. Multilevel modeling was used to examine effects and their predictors. RESULTS: Younger participants with lower levels of tinnitus distress were more likely to dropout while those with higher tinnitus distress at baseline and quality of life were more likely to receive step 2 of treatment. MLM analyses revealed, with one exception, no relation between any baseline variable and outcome change over time. Most participants' improvement exceeded minimally clinical important difference criteria for quality of life, tinnitus-related handicap, and tinnitus distress. CONCLUSIONS: Results from this large pragmatic study complements those from randomized controlled trials of cognitive behavioral therapy for chronic tinnitus distress and supports its implementation under "real-world" conditions.

The Daily Experience of Subjective Tinnitus: Ecological Momentary Assessment Versus End-of-Day Diary.

OBJECTIVE: Traditional methods of self-report assessments are susceptible to bias (i.e., memory, recall, and recency). Ecological momentary assessment (EMA) may curb these biases by repeated momentary assessment of the participant throughout the day. High costs and participant burden may, however, impede the use of EMA. End-of-day diary (EDD) provides an attractive alternative to EMA, though no direct comparison has been performed in the tinnitus field. DESIGN: Four thousand seven-hundred thirty-two data entries were collected from nine participants undergoing cognitive behavioral treatment for tinnitus. Eleven equivalent EMA and EDD items were collected for approximately 3 months. Tinnitus experience (i.e., anger, annoyance, avoidance, distraction, fear, invasiveness, pleasantness, and sadness) and well-being (i.e., anxiety, happiness, and stress) were correlated and means compared (t-tests). RESULTS: All variables presented adequate correlation (r > 0.68) between the EMA and EDD counterparts. Small (<3.9%) significant daily mean differences between EMA and EDD were found for six variables (tinnitus anger, invasiveness, pleasantness, sadness, as well as anxiety and stress) with worse results reported in EDD. CONCLUSION: The small significant effects found may be attributed to the large number of data points. When EMA is not possible or recommended, EDD provides a viable alternative to assess tinnitus experience daily. Further research on the underlying mechanisms of tinnitus experience and recollection is warranted.

The Fear of Tinnitus Questionnaire: Toward a Reliable and Valid Means of Assessing Fear in Adults with Tinnitus.

OBJECTIVES: The purpose of this study was to assess the factor structure, reliability, and validity of the Fear of Tinnitus Questionnaire (FTQ); a brief self-report measure of people's fears about potential cognitive, emotional, behavioral, and social consequences of living with tinnitus. DESIGN: Five hundred eighty-eight Dutch-speaking adults with tinnitus completed an online battery of questionnaires measuring tinnitus-related distress, fear, catastrophizing, and quality of life. The sample was randomly split into two to perform exploratory and Bayesian confirmatory factor analyses. A subsample of participants (n = 144) completed the battery of questionnaires a second time after a 2-week interval to calculate test-retest reliability and conduct a Bland-Altman analysis. Convergent and concurrent validity of the FTQ was assessed with the complete data set and measures of tinnitus-related distress as the outcome. RESULTS: Exploratory factor analyses indicated that single- and three-factor FTQ models were both valid solutions. Posterior predictive p values for the Bayesian confirmatory factor analyses ranged between 0.51 and 0.53 indicating that the respective models were an excellent fit for the data. The FTQ showed excellent test-retest reliability (average value intraclass correlation coefficient (ICC) = 0.92; 95% confidence interval, 0.89-0.95) and in the Bland-Altman analysis, satisfactory agreement between participants' scores after a 2-week interval. Furthermore, the FTQ demonstrated good internal reliability (α = 0.83, 95% confidence interval, 0.81-0.85) and added statistically significant amounts of variance to models predicting tinnitus-related distress and interference in daily life. CONCLUSIONS: The FTQ has good psychometric properties and can be used to assess people's fear of tinnitus in research or clinical settings. Further work to establish the reliability and validity should be conducted and include an examination of a version of the FTQ that uses Likert-type response scales which might offer improved sensitivity.

Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial.

BACKGROUND: Up to 21% of adults will develop tinnitus, which is one of the most distressing and debilitating audiological problems. The absence of medical cures and standardised practice can lead to costly and prolonged treatment. We aimed to assess effectiveness of a stepped-care approach, based on cognitive behaviour therapy, compared with usual care in patients with varying tinnitus severity. METHODS: In this randomised controlled trial, undertaken at the Adelante Department of Audiology and Communication (Hoensbroek, Netherlands), we enrolled previously untreated Dutch speakers (aged >18 years) who had a primary complaint of tinnitus but no health issues precluding participation. An independent research assistant randomly allocated patients by use of a computer-generated allocation sequence in a 1:1 ratio, stratified by tinnitus severity and hearing ability, in block sizes of four to receive specialised care of cognitive behaviour therapy with sound-focused tinnitus retraining therapy or usual care. Patients and assessors were masked to treatment assignment. Primary outcomes were health-related quality of life (assessed by the health utilities index score), tinnitus severity (tinnitus questionnaire score), and tinnitus impairment (tinnitus handicap inventory score), which were assessed before treatment and at 3 months, 8 months, and 12 months after randomisation. We used multilevel mixed regression analyses to assess outcomes in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00733044. FINDINGS: Between September, 2007 and January, 2011, we enrolled and treated 492 (66%) of 741 screened patients. Compared with 247 patients assigned to usual care, 245 patients assigned to specialised care improved in health-related quality of life during a period of 12 months (between-group difference 0·059, 95% CI 0·025 to 0·094; effect size of Cohen's d=0·24; p=0·0009), and had decreased tinnitus severity (-8·062, -10·829 to -5·295; d=0·43; p<0·0001) and tinnitus impairment (-7·506, -10·661 to -4·352; d=0·45; p<0·0001). Treatment seemed effective irrespective of initial tinnitus severity, and we noted no adverse events in this trial. INTERPRETATION: Specialised treatment of tinnitus based on cognitive behaviour therapy could be suitable for widespread implementation for patients with tinnitus of varying severity. FUNDING: Netherlands Organisation for Health Research and Development (ZonMW).

Tinnitus: a cost study.

OBJECTIVES: The aim of this study was to examine the costs of tinnitus in The Netherlands from a health care and a societal perspective. Furthermore, the impact of disease characteristics and demographic characteristics on these costs were examined. METHODS: A bottom-up cost of illness study was performed, using the baseline data on a cost questionnaire of a randomized controlled trial investigating the (cost) effectiveness of an integral multidisciplinary treatment for tinnitus versus care as usual. Mean yearly costs were multiplied by the prevalence figure of tinnitus for the adult general population to estimate the total cost of illness of tinnitus to society. Because cost data usually are not normally distributed, a nonparametric bootstrap resampling procedure with 1000 simulations was performed to determine statistical uncertainty of the cost estimates per category. Several questionnaires measuring disease and demographic characteristics were administered. The impact of disease characteristics and demographics on costs was investigated using a multivariate regression analysis. RESULTS: Total mean societal cost of illness was €6.8 billion (95% confidence interval: €3.9 billion-€10.8 billion). The larger part of total cost of illness was not related to health care. Total mean health care costs were €1.9 billion (95% confidence interval: €1.4 billion-€2.5 billion). Significant predictors of both health care costs and societal costs were tinnitus severity, age, shorter duration of tinnitus, and more severe depression. CONCLUSION: The economical burden of tinnitus to society is substantial, and severity of tinnitus is an important predictor of the costs made by patients.

Autobiographical memory specificity in patients with tinnitus versus patients with depression and normal controls.

Several studies show that patients with depression and post-traumatic stress disorder respond with fewer specific autobiographical memories in a cued memory task (i.e. the autobiographical memory test; AMT) compared to healthy controls. One previous study found this phenomenon among tinnitus patients as well (Andersson, Ingerholt, & Jansson, 2003). The aim of this study was to replicate the previous study with an additional control group of depressed patients and memory errors as measured with the AMT as an additional outcome. We included 20 normal hearing tinnitus patients, 20 healthy controls and 20 persons diagnosed with clinical depression. The AMT was administered together with self-report measures of depression, anxiety and tinnitus distress. Both the tinnitus and depression groups differed from the healthy control group in that they reported fewer specific autobiographical memories. There were, however, differences between the tinnitus and depression groups in terms of the errors made on the AMT. The depression group had more overgeneral memories than the normal control group, whereas the tinnitus group did not differ from the control group on this memory error. The tinnitus group had more semantic associations and non-memories than the other two groups, suggesting that executive functioning may play a role for the tinnitus group when completing the AMT. Clinical and theoretical implications of the findings are discussed.

Fear influences phantom sound percepts in an anechoic room.

Aims and hypotheses: In an environment of absolute silence, researchers have found many of their participants to perceive phantom sounds (tinnitus). With this between-subject experiment, we aimed to elaborate on these research findings, and specifically investigated whether-in line with the fear-avoidance model of tinnitus perception and reactivity-fear or level of perceived threat influences the incidence and perceptual qualities of phantom sound percepts in an anechoic room. We investigated the potential role of individual differences in anxiety, negative affect, noise sensitivity and subclinical hearing loss. We hypothesized that participants who experience a higher level of threat would direct their attention more to the auditory system, leading to the perception of tinnitus-like sounds, which would otherwise be subaudible, and that under conditions of increased threat, narrowing of attention would lead to perceptual distortions. Methods: In total, N = 78 normal-hearing volunteers participated in this study. In general, the study sample consisted of young, mostly female, university students. Their hearing was evaluated using gold-standard pure tone audiometry and a speech-in-noise self-test (Digit Triplet Test), which is a sensitive screening test to identify subclinical hearing loss. Prior to a four-minute stay in an anechoic room, we randomized participants block design-wise in a threat (N = 37) and no-threat condition (N = 41). Participants in the threat condition were deceived about their hearing and were led to believe that staying in the room would potentially harm their hearing temporarily. Participants were asked whether they perceived sounds during their stay in the room and rated the perceptual qualities of sound percepts (loudness and unpleasantness). They were also asked to fill-out standardized questionnaires measuring anxiety (State-Trait Anxiety Inventory), affect (Positive and Negative Affect Schedule) and noise sensitivity (Weinstein Noise Sensitivity Scale). The internal consistency of the questionnaires used was verified in our study sample and ranged between α = 0.61 and α = 0.90. Results: In line with incidence rates reported in the literature, 74% of our participants reported having heard tinnitus-like sounds in the anechoic room. Speech-in-noise identification ability was comparable for both groups of participants. The experimental manipulation of threat was proven to be effective, as indicated by significantly higher scores on a Threat Manipulation Checklist among participants in the threat condition as compared to those in the no-threat condition (p < 0.01). Nevertheless, participants in the threat condition were as likely to report tinnitus percepts as participants in the no-threat condition (p = 1), and tinnitus percepts were not rated as being louder (p = 0.76) or more unpleasant (p = 0.64) as a function of level of threat. For participants who did experience tinnitus percepts, a higher level of threat was associated with a higher degree of experienced unpleasantness (p < 0.01). These associations were absent in those who did not experience tinnitus. Higher negative affect was only slightly associated with higher ratings of tinnitus unpleasantness (p < 0.01). Conclusion: Whereas our threat manipulation was successful in elevating the level of fear, it did not contribute to a higher percentage of participants perceiving tinnitus-like sounds in the threat condition. However, higher levels of perceived threat were related to a higher degree of perceived tinnitus unpleasantness. The findings of our study are drawn from a rather homogenous participant pool in terms of age, gender, and educational background, challenging conclusions that are applicable for the general population. Participants generally obtained normophoric scores on independent variables of interest: they were low anxious, low noise-sensitive, and there was little evidence for the presence of subclinical hearing loss. Possibly, there was insufficient variation in scores to find effects.

Catastrophizing and fear of tinnitus predict quality of life in patients with chronic tinnitus.

OBJECTIVES: It is well established that catastrophic misinterpretations and fear are involved in the suffering and disability of patients with chronic pain. This study investigated whether similar processes explain suffering and disability in patients with chronic tinnitus. We hypothesized that patients who catastrophically (mis)interpret their tinnitus would be more fearful of tinnitus, more vigilant toward their tinnitus, and report less quality of life. Moreover, tinnitus-related fear was expected to act as a mediator in reduced quality of life. DESIGN: Sixty-one tinnitus patients from an outpatient ENT department of the University Hospital of Antwerp (Belgium) completed a number of questionnaires about their tinnitus. Hierarchical regression analyses were performed to test hypothesized associations and to assess mediation by tinnitus-related fear. RESULTS: Analyses revealed significant associations between catastrophizing and fear and between catastrophizing and increased attention toward the tinnitus. Furthermore, both tinnitus-related catastrophizing and fear were negatively associated with quality of life; moreover, tinnitus-related fear fully mediated the association between catastrophizing about the tinnitus and quality of life. CONCLUSIONS: The findings confirm earlier suggestions that tinnitus-related concerns and fears are associated with impaired quality of life, which is in line with a cognitive behavioral account of chronic tinnitus. Future research avenues and clinical applications are discussed.

Tinnitus interferes with daily life activities: a psychometric examination of the Tinnitus Disability Index.

OBJECTIVES: Tinnitus Disability Index (TDI) is presented as a novel and brief self-report measure for the assessment of the interference of tinnitus with performance in specific daily life activities. We hypothesized that the TDI is a reliable and valid measure and that tinnitus disability is strongly associated with tinnitus severity, subjective tinnitus intensity ratings, and ratings of general health. DESIGN: Six hundred fifteen tinnitus patients from across the Netherlands completed online a number of questionnaires about their tinnitus, their general health, and demographics. Two samples were extracted by a random split: Sample I (N = 311) for exploratory factor analysis and Sample II (N = 304) for confirmatory analysis, using structural equation modeling. One hundred forty-three of the first included respondents repeated assessment after a 2-wk time interval for test/retest analysis. Regression analyses were employed to investigate construct validity. RESULTS: Present analyses reveal that tinnitus disability, as measured with the TDI, might be best understood as a single-component construct, that is, one single underlying factor. The TDI is reliable over time, and tinnitus-related disability, as measured with the TDI, is strongly associated with subjective ratings of tinnitus intensity, negatively associated with quality of life ratings, and distress due to tinnitus. CONCLUSIONS: The TDI is a brief and easily administered index measuring a unique construct, namely the experienced interference of the tinnitus with daily life activities, which is invaluable in the assessment and treatment of tinnitus patients.

Assessment of health state in patients with tinnitus: a comparison of the EQ-5D and HUI mark III.

OBJECTIVES: Expressing the outcomes of treatment in quality-adjusted life years is increasingly important as a tool to aid decision makers concerning the allocation of scarce resources within the health care sector. A quality-adjusted life year is a measure of life expectancy that is weighted by health-related quality of life. These weights are referred to as utility scores and are usually measured by multiattribute utility measures. Several studies found that different utility measures provide different estimates of the same person's level of utility. The aim of this study was to investigate which of two widely used utility measures, the EQ-5D and the HUI mark III, is preferred in a tinnitus population. METHODS: Baseline and follow-up data on EQ-5D and HUI mark III of 429 patients of a randomized controlled clinical trial, investigating cost-effectiveness of usual care versus specialized care of tinnitus, were included. Agreement, discriminative power, and responsiveness of the health state description and the utility scores were examined. RESULTS: Corresponding dimensions of the EQ-5D and HUI mark III showed large correlations; although ceiling effects were more frequently observed in the EQ-5D. Mean utility scores for EQ-5D (0.77; SD 0.22) and HUI mark III (0.64; SD 0.28) were significantly different (Wilcoxon signed ranks test, p < 0.001), and agreement was low to moderate (intraclass correlation coefficient = 0.53). Both health state description and utility scores of both measures discriminated between different severity groups. These groups were based on baseline scores of the Tinnitus Questionnaire. The HUI mark III had a higher ability than the EQ-5D to detect improved patients from randomly selected pairs of improved and unimproved patients. CONCLUSION: This study shows that different utility measures lead to different health state descriptions and utility scores among tinnitus patients. However, both measures are capable of discriminating between clinically different groups. The HUI mark III is more responsive than the EQ-5D, and therefore preferred in a tinnitus population.

Effects of ecological momentary assessment (EMA) induced monitoring on tinnitus experience: A multiple-baseline single-case experiment.

INTRODUCTION: Ecological momentary assessment (EMA) is a method capable of assessing tinnitus experience throughout the day, enabling the exploration of daily dynamic changes of tinnitus expression. However, the effects on patients' tinnitus experience itself are still largely unknown. This study seeks to test the hypothesis that the use of EMA negatively influences tinnitus experience in participants with severe tinnitus. METHOD: A multiple-baseline single-case experimental design included four severely affected tinnitus volunteers who were recruited online and randomized into different phasing schedules. Baseline phase (A) ranged from 11 to 24 days, followed by an EMA phase (B) for the remainder of the 33-day schedule. End-of-day diary assessments of tinnitus experience (e.g., annoyance, intrusiveness, mood) were visually inspected, and complemented with inferential statistics (randomization tests and Tau-U). RESULTS: End-of-day diary data revealed no change in broadened median between phases. Nevertheless, tinnitus experience scores improved as variability decreased and a significant improvement in stress was observed through weighted Tau-U statistics. CONCLUSION: Findings of this study corroborate that EMA assessment does not negatively affect tinnitus experience. On the contrary, participants may have improved. The underlying mechanism of improvements are still to be uncovered. Findings are limited to severely affected tinnitus sufferers at present.

Tinnitus healthcare: a survey revealing extensive variation in opinion and practices across Europe.

Tinnitus remains a scientific and clinical problem whereby, in spite of increasing knowledge on effective treatment and management for tinnitus, very little impact on clinical practice has been observed. There is evidence that prolonged, obscure and indirect referral trajectories persist in usual tinnitus care. OBJECTIVE: It is widely acknowledged that efforts to change professional practice are more successful if barriers are identified and implementation activities are systematically tailored to the specific determinants of practice. The aim of this study was to administer a health service evaluation survey to scope current practice and knowledge of standards in tinnitus care across Europe. The purpose of this survey was to specifically inform the development process of a European clinical guideline that would be implementable in all European countries. DESIGN: A health service evaluation survey was carried out. SETTING: The survey was carried out online across Europe. PARTICIPANTS: Clinical experts, researchers and policy-makers involved in national tinnitus healthcare and decision-making. OUTCOME MEASURES: A survey was developed by the study steering group, piloted on clinicians from the TINNET network and underwent two iterations before being finalised. The survey was then administered to clinicians and policy-makers from 24 European countries. RESULTS: Data collected from 625 respondents revealed significant differences in national healthcare structures, use of tinnitus definitions, opinions on characteristics of patients with tinnitus, assessment procedures and particularly in available treatment options. Differences between northern and eastern European countries were most notable. CONCLUSIONS: Most European countries do not have national clinical guidelines for the management of tinnitus. Reflective of this, clinical practices in tinnitus healthcare vary dramatically across countries. This equates to inequities of care for people with tinnitus across Europe and an opportunity to introduce standards in the form of a European clinical guideline. This survey has highlighted important barriers and facilitators to the implementation of such a guideline.

Tinnitus-related fear: Mediating the effects of a cognitive behavioural specialised tinnitus treatment.

OBJECTIVE: Cognitive behavioural treatments (CBT) for the reduction of tinnitus complaints have been shown to be effective; however the specific mechanisms of change are yet to be unveiled. Reductions in tinnitus-related fear have been indicated to be an important factor in alleviating tinnitus suffering. The role of tinnitus-related fear has been proposed as a mediator explaining the cognitive behavioural treatment effects on tinnitus severity, tinnitus-related impairment and general quality of life of tinnitus patients. METHODS: A two-group, single-centre RCT was carried out with adult tinnitus patients (n = 492), with 3 follow-up assessments up to 12 months after randomization. Patients were randomly assigned to Usual Care (UC) or Specialised cognitive behavioral stepped Care (SC). A repeated-measures design, with group as a between subjects factor, and time as the within-subject factor, was used in an intention-to-treat analysis. Mixed regressions for assessing mediation effects were performed with general health, tinnitus distress, tinnitus related impairment as the dependent variables and tinnitus related fear as the mediator variable. RESULTS: Tinnitus-related fear appears to mediate part of the treatment benefits of specialized CBT for Tinnitus, as compared to usual care, with respect to increased quality of life ratings, and decreased tinnitus severity and tinnitus related impairments. CONCLUSIONS: The effectiveness of specialized cognitive behavioural treatment approaches for tinnitus might be partly explained by significant reductions in tinnitus-related fear. These results are relevant in that currently, though CBT approaches in tinnitus management have been proven to lead to decreased suffering of tinnitus patients, the psychological mechanisms causing these benefits are still to be discovered.

Different Teams, Same Conclusions? A Systematic Review of Existing Clinical Guidelines for the Assessment and Treatment of Tinnitus in Adults.

Background: Though clinical guidelines for assessment and treatment of chronic subjective tinnitus do exist, a comprehensive review of those guidelines has not been performed. The objective of this review was to identify current clinical guidelines, and compare their recommendations for the assessment and treatment of subjective tinnitus in adults. Method: We systematically searched a range of sources for clinical guidelines (as defined by the Institute of Medicine, United States) for the assessment and/or treatment of subjective tinnitus in adults. No restrictions on language or year of publication were applied to guidelines. Results: Clinical guidelines from Denmark, Germany, Sweden, The Netherlands, and the United States were included in the review. There was a high level of consistency across the guidelines with regard to recommendations for audiometric assessment, physical examination, use of a validated questionnaire(s) to assess tinnitus related distress, and referral to a psychologist when required. Cognitive behavioral treatment for tinnitus related distress, use of hearing aids in instances of hearing loss and recommendations against the use of medicines were consistent across the included guidelines. Differences between the guidelines centered on the use of imaging in assessment procedures and sound therapy as a form of treatment for tinnitus distress respectively. Conclusion: Given the level of commonality across tinnitus guidelines from different countries the development of a European guideline for the assessment and treatment of subjective tinnitus in adults seems feasible. This guideline would have the potential to benefit the large number of clinicians in countries where clinical guidelines do not yet exist, and would support standardization of treatment for patients across Europe.

Innovations in Doctoral Training and Research on Tinnitus: The European School on Interdisciplinary Tinnitus Research (ESIT) Perspective.

Tinnitus is a common medical condition which interfaces many different disciplines, yet it is not a priority for any individual discipline. A change in its scientific understanding and clinical management requires a shift toward multidisciplinary cooperation, not only in research but also in training. The European School for Interdisciplinary Tinnitus research (ESIT) brings together a unique multidisciplinary consortium of clinical practitioners, academic researchers, commercial partners, patient organizations, and public health experts to conduct innovative research and train the next generation of tinnitus researchers. ESIT supports fundamental science and clinical research projects in order to: (1) advancing new treatment solutions for tinnitus, (2) improving existing treatment paradigms, (3) developing innovative research methods, (4) performing genetic studies on, (5) collecting epidemiological data to create new knowledge about prevalence and risk factors, (6) establishing a pan-European data resource. All research projects involve inter-sectoral partnerships through practical training, quite unlike anything that can be offered by any single university alone. Likewise, the postgraduate training curriculum fosters a deep knowledge about tinnitus whilst nurturing transferable competencies in personal qualities and approaches needed to be an effective researcher, knowledge of the standards, requirements and professionalism to do research, and skills to work with others and to ensure the wider impact of research. ESIT is the seed for future generations of creative, entrepreneurial, and innovative researchers, trained to master the upcoming challenges in the tinnitus field, to implement sustained changes in prevention and clinical management of tinnitus, and to shape doctoral education in tinnitus for the future.

Genetics of Tinnitus: An Emerging Area for Molecular Diagnosis and Drug Development.

Subjective tinnitus is the perception of sound in the absence of external or bodily-generated sounds. Chronic tinnitus is a highly prevalent condition affecting over 70 million people in Europe. A wide variety of comorbidities, including hearing loss, psychiatric disorders, neurodegenerative disorders, and temporomandibular joint (TMJ) dysfunction, have been suggested to contribute to the onset or progression of tinnitus; however, the precise molecular mechanisms of tinnitus are not well understood and the contribution of genetic and epigenetic factors remains unknown. Human genetic studies could enable the identification of novel molecular therapeutic targets, possibly leading to the development of novel pharmaceutical therapeutics. In this article, we briefly discuss the available evidence for a role of genetics in tinnitus and consider potential hurdles in designing genetic studies for tinnitus. Since multiple diseases have tinnitus as a symptom and the supporting genetic evidence is sparse, we propose various strategies to investigate the genetic underpinnings of tinnitus, first by showing evidence of heritability using concordance studies in twins, and second by improving patient selection according to phenotype and/or etiology in order to control potential biases and optimize genetic data output. The increased knowledge resulting from this endeavor could ultimately improve the drug development process and lead to the preventive or curative treatment of tinnitus.

Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults.

BACKGROUND: There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus. METHODS: Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded. RESULTS: Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used. CONCLUSIONS: Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments. PROSPERO REGISTRATION: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525 . Registered on 12 March 2015 revised on 15 March 2016.

Cognitive-behavioral treatments for tinnitus: a review of the literature.

BACKGROUND: Tinnitus can be defined as the perception of an auditory sensation, perceivable without the presence of an external sound. PURPOSE: The aim of this article is to systematically review the peer-reviewed literature on treatment approaches for tinnitus based on cognitive-behavioral therapy (CBT) and to provide a historical overview of developments within these approaches. RESEARCH DESIGN: Experimental studies, (randomized) trials, follow-up assessments, and reviews assessing educational, counseling, psychological, and CBT treatment approaches were identified as a result of an electronic database metasearch. RESULTS: A total of 31 (of the initial 75 studies) were included in the review. Results confirm that CBT treatment for tinnitus management is the most evidence-based treatment option so far. Though studied protocols are diverse and are usually a combination of different treatment elements, and tinnitus diagnostics and outcome assessments vary over investigations, a common ground of therapeutic elements was established, and evidence was found to be robust enough to guide clinical practice. CONCLUSIONS: Treatment strategy might best be CBT-based, moving toward a more multidisciplinary approach. There is room for the involvement of different disciplines, using a stepped-care approach. This may provide brief and effective treatment for a larger group of tinnitus patients, and additional treatment steps can be provided for those suffering on a more severe level.

Cost-effectiveness of specialized treatment based on cognitive behavioral therapy versus usual care for tinnitus.

OBJECTIVE: To evaluate the cost-effectiveness of specialized multidisciplinary tinnitus treatment based on cognitive behavioral therapy, compared with care as usual. DESIGN: Randomized controlled trial including an economic evaluation from a health-care and societal perspective, using a one-year time horizon. SETTING: Audiologic center. PATIENTS: A referred sample of 626 patients with tinnitus were eligible for participation. Approximately 492 patients were included in the study. Eighty-six (35%) of 247 patients in the usual care group, and 74 (30%) of 245 patients in the specialized care group were lost to follow-up by month 12. MAIN OUTCOME MEASURES: Quality adjusted life years (QALYs) as measured with the Health Utilities Index Mark III and cost in US dollars. RESULTS: Compared with patients receiving usual care, patients who received specialized care gained on average 0.015 QALYs (95% bootstrapped confidence interval [BCI], -0.03 to 0.06). The incremental costs from a societal perspective are $357 (95% BCI,-$1,034 to $1,785). The incremental cost per QALY from a societal perspective amounted to $24,580. The probability that SC is cost-effective from a societal perspective is 58% for a willingness to pay for a QALY of $45,000. CONCLUSION: Specialized multidisciplinary tinnitus treatment based on cognitive behavioral therapy is cost-effective as compared with usual care. Although uncertainty surrounding the incremental costs and effects is considerable, sensitivity analysis indicated that cost-effectiveness results were robust.