Randomised controlled trial of interventions for bothersome tinnitus: DesyncraTM versus cognitive behavioural therapy.

OBJECTIVE: Compare the relative efficacy of DesyncraTM and Cognitive Behavioural Therapy (CBT). DESIGN AND STUDY SAMPLE: Sixty-one participants were randomly assigned to receive either DesyncraTM (n = 29) or CBT (n = 32). Randomisation included stratification regarding current hearing aid (HA) use. Depending on group assignment, participants attended approximately 7-12 visits. Tinnitus distress was measured using the Tinnitus Questionnaire (TQ). RESULTS: Mean TQ scores decreased post-baseline from 5-15 points across treatment arms and strata. Model-based findings for the no-HA stratum showed a difference of -2.0 TQ points favouring Desyncra at 24-weeks, with a 90% posterior interval varying from -5.4 points favouring Desyncra to 0.8 TQ points favouring CBT. For the HA stratum, results show a difference of -1.0 TQ points favouring Desyncra, with a 90% posterior interval ranging from -4.7 points favouring Desyncra to 2.9 points favouring CBT. CONCLUSIONS: The difference between Desyncra and CBT on average showed greater improvement with Desyncra in the no-HA stratum by about 2 TQ points. To the extent that the study sample represents a clinical population and recognising the assumptions in the design and analysis, these results suggest Desyncra is just as effective or more so than CBT in reducing tinnitus distress.

Telephone-Based Progressive Tinnitus Management for Persons With and Without Traumatic Brain Injury: A Randomized Controlled Trial.

OBJECTIVES: This randomized controlled trial evaluated the efficacy of delivering coping skills education from Progressive Tinnitus Management (PTM) by telephone (Tele-PTM). The trial followed a previous pilot study that showed positive results for Tele-PTM. DESIGN: Participants included individuals with bothersome tinnitus (N = 205) located anywhere within the United States. A special emphasis was given to including individuals who had experienced one or more traumatic brain injuries (TBIs). Participants were randomized to either Tele-PTM intervention or 6-month wait-list control (WLC). The Tele-PTM intervention involved five telephone appointments-two led by an audiologist (teaching how to use therapeutic sound) and three by a psychologist (teaching coping skills derived from cognitive-behavioral therapy). It was hypothesized that Tele-PTM would be more effective than WLC in reducing functional effects of tinnitus as measured with the Tinnitus Functional Index. Additional outcome measures included the Self-Efficacy for Managing Reactions to Tinnitus questionnaire and the Hospital Anxiety and Depression Scale. The effect of Tele-PTM on outcomes was estimated using linear mixed models. RESULTS: Overall results showed convincingly that the Tele-PTM group had significantly better outcomes than the WLC group. These results were consistent across all outcome measures, indicating not only a reduction of tinnitus functional distress but also increased self-efficacy. Improvements in measures of anxiety and depression were also observed. Tele-PTM participants in all TBI categories showed significant improvement. CONCLUSIONS: Results provide strong support for use of Tele-PTM methodology for persons with bothersome tinnitus, regardless of whether the person also has TBI symptoms. The effect size for Tele-PTM was high for the primary outcome measure, the Tinnitus Functional Index, and all other outcome measures showed significant improvement. Combined with our previous pilot study, the Tele-PTM method is validated for potential nationwide provision of tinnitus services.

Toward development of a tinnitus magnitude index.

OBJECTIVES: The aim of the study was to provide preliminary evidence of a unique "tinnitus magnitude" domain describing intensity of tinnitus perception that will assist in the development of a cognitive-behavioral mediation model of psychological distress associated with tinnitus. DESIGN: A sample of 347 participants with tinnitus was previously recruited from four audiology clinics for the purpose of developing a tinnitus distress measure, the Tinnitus Functional Index (TFI). From the questions used for TFI development, potential tinnitus magnitude items were selected by including those that minimally overlapped with tinnitus reactions. The three items having the least overlap were analyzed retrospectively to assess internal consistency, test-retest reliability, group differences using demographics and tinnitus-relevant descriptive variables, and discriminant validity. The three-item scale was developed in an effort to establish a model for prospective development of a Tinnitus Magnitude Index (TMI) that would assess the magnitude of tinnitus variables independent of reactions to tinnitus. RESULTS: Internal consistency (α = 0.86) and repeated measures tests (r = 0.74, df = 29, p < 0.001) indicate the three-item scale is reliable. Discriminant validity was supported by only moderate correlations (r≥ 0.30 and r ≤ 0.69) of the scale with the Tinnitus Handicap Inventory (r = 0.62), the Beck Depression Inventory for Primary Care (r = 0.38), and the seven independent domains of tinnitus reactions measured using subscales of the TFI (r = 0.49 to 0.72). Correlations between the scale and two tinnitus reactions (distress) subscales were high (r > 0.70) as compared with moderate correlations. CONCLUSIONS: This study involved a retrospective analysis of data from questions that were originally evaluated for use in a tinnitus outcome questionnaire. The analysis was conducted to establish a model for prospective development of a TMI. Results of this analysis suggest that a TMI can be developed that would provide a reliable and valid measure of tinnitus magnitude that overlaps minimally in content with measures of cognitive, behavioral, and emotional tinnitus reactions. A fully validated TMI would provide a measure of tinnitus magnitude that is not confounded by emotional reactions to tinnitus or general depressive symptoms and would be useful in developing a testable model of psychological distress due to tinnitus. Although the primary goal is to develop a measure of tinnitus magnitude that predicts cognitive, behavioral, and emotional reactions to tinnitus, a TMI may also have utility in assessing this construct in clinical settings.

Factors affecting the implementation of evidence-based Progressive Tinnitus Management in Department of Veterans Affairs Medical Centers.

PURPOSE: Progressive Tinnitus Management (PTM) is an evidence-based interdisciplinary stepped-care approach to improving quality of life for patients with tinnitus. PTM was endorsed by Department of Veterans Affairs (VA) Audiology leadership in 2009. Factors affecting implementation of PTM are unknown. We conducted a study to: 1) estimate levels of PTM program implementation in VA Audiology and Mental Health clinics across the country; and 2) identify barriers and facilitators to PTM implementation based on the experiences of VA audiologists and mental health providers. METHOD: We conducted an anonymous, web-based survey targeting Audiology and Mental Health leaders at 144 major VA facilities. Quantitative analyses summarized respondents' facility characteristics and levels of program implementation (full PTM, partial PTM, or no PTM). Qualitative analyses identified themes in factors influencing the implementation of PTM across VA sites. RESULTS: Surveys from 87 audiologists and 66 mental health clinicians revealed that few facilities offered full PTM; the majority offered partial or no PTM. Inductive analysis of the open-ended survey responses identified seven factors influencing implementation of PTM: 1) available resources, 2) service collaboration, 3) prioritization, 4) Veterans' preferences and needs, 5) clinician training, 6) awareness of (evidence-based) options, and 7) perceptions of scope of practice. CONCLUSION: Results suggest wide variation in services provided, a need for greater engagement of mental health providers in tinnitus care, and an interest among both audiologists and mental health providers in receiving tinnitus-related training. Future research should address barriers to PTM implementation, including methods to: 1) improve understanding among mental health providers of their potential role in tinnitus management; 2) enhance coordination of tinnitus-related care between health care disciplines; and 3) collect empirical data on Veterans' need for and interest in PTM, including delivery by telehealth modalities.

Cognitive Behavioral Therapy for Veterans With Tinnitus.

Cognitive behavioral therapy encourages acquisition, practice, and use of a range of specific coping strategies to enhance perceptions of self-control and self-efficacy for patients with tinnitus.

Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used With Progressive Tinnitus Management.

Purpose: This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). Method: At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention involved 5 group workshops: 2 led by an audiologist (teaching how to use sound as therapy) and 3 by a psychologist (teaching coping skills derived from cognitive behavioral therapy). It was hypothesized that PTM would be more effective than wait-list control in reducing functional effects of tinnitus and that there would be no differences in effectiveness between sites. Results: At both sites, a statistically significant improvement in mean Tinnitus Functional Index scores was seen at 6 months for the PTM group. Combined data across sites revealed a statistically significant improvement in Tinnitus Functional Index relative to wait-list control. The effect size for PTM using the Tinnitus Functional Index was 0.36 (small). Conclusions: Results suggest that PTM is effective at reducing tinnitus-related functional distress in clinical settings. Although effect sizes were small, they provide evidence of clinical effectiveness of PTM in the absence of stringent research-related inclusion criteria and with a relatively small number of sessions of cognitive behavioral therapy.

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.

Development of a progressive audiologic tinnitus management program for Veterans with tinnitus.

Tinnitus is the most prevalent service-connected disability awarded to Veterans. However, clinical protocols for management of tinnitus have been inconsistent across Department of Veterans Affairs (VA) medical centers. A study was funded to develop and pilot test a protocol to provide tinnitus services consistently across VA audiology clinics. Drawing on a series of prior VA and external research projects, a clinical model was formulated, supporting materials in multimedia were developed, and a pilot study was conducted. Five hierarchical levels of care were defined and labeled the Progressive Audiologic Tinnitus Management (PATM) model. The model facilitates access to medical services for tinnitus and includes detailed protocols for evaluation, education, and counseling of patients. Patients at each level of care have the option to "progress" to the next level of PATM if further services are required. Clinical procedures were defined for each level and materials were produced for audiologists and patients. The PATM model was then piloted with clinical patients at the James A. Haley Veterans' Hospital (JAHVH) in Tampa, Florida. Throughout the pilot study, feedback from patients and clinicians was carefully noted. Training materials for audiologists, incorporation of the protocol into clinic activities, and patient outcomes were evaluated. The model was implemented within the JAHVH Audiology Clinic and to assist Veterans with tinnitus management. The most notable finding was how little tinnitus-specific intervention was required for the majority of patients. This finding supports a clinical model that offers stepped-care ("progressive") levels of care until tinnitus management is achieved by the patient.

Pilot study to develop telehealth tinnitus management for persons with and without traumatic brain injury.

Tinnitus, or "ringing in the ears," affects 10%-15% of adults; cases can be problematic and require lifelong management. Many people who have experienced traumatic brain injury (TBI) also experience tinnitus. We developed Progressive Tinnitus Management (PTM), which uses education and counseling to help patients learn how to self-manage their reactions to tinnitus. We adapted PTM by delivering the intervention via telephone and by adding cognitive-behavioral therapy. A pilot study was conducted to evaluate the feasibility and potential efficacy of this approach for individuals with and without TBI. Participants with clinically significant tinnitus were recruited into three groups: probable symptomatic mild TBI (n = 15), moderate to severe TBI (n = 9), and no symptomatic TBI (n = 12). Participants received telephone counseling (six sessions over 6 months) by an audiologist and a psychologist. Questionnaires were completed at baseline, 12 weeks, and 24 weeks. All groups showed trends reflecting improvement in self-perceived functional limitations due to tinnitus. A follow-up randomized clinical study is underway.