Rilana F. F. Cima

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 Cohens 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).

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.

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.

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 &OV0556;6.8 billion (95% confidence interval: &OV0556;3.9 billion–&OV0556;10.8 billion). The larger part of total cost of illness was not related to health care. Total mean health care costs were &OV0556;1.9 billion (95% confidence interval: &OV0556;1.4 billion–&OV0556;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.

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.

Cost-effectiveness of multidisciplinary management of Tinnitus at a specialized Tinnitus centre

BackgroundTinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus, quality of life is often impaired. At present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests that a comprehensive multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of a comprehensive treatment provided by a specialized tinnitus center versus usual care. This paper describes the study protocol.Methods/DesignIn a randomized controlled clinical trial 198 tinnitus patients will be randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus sufferers referred to the audiological centre are eligible. Included patients will be followed for 12 months. Primary outcome measure is generic quality of life (measured with the Health Utilities Index Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the number of patients to include is 198. Economic evaluation will be performed from a societal perspective.DiscussionThis is, to our knowledge, the first randomized controlled trial that evaluates a comprehensive treatment of tinnitus and includes a full economic evaluation from a societal perspective. If this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated.Trial RegistrationThe trial has been registered at ClinicalTrial.gov. The trial registration number is NCT00733044

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 persons 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.

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.

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.

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.