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. ACKNOWLEDGMENTS: The authors give special recognition for significant contributions to this study by Cody Blankenship, BS; Johnna Gonzalez, BA, MS, BSN; Samantha Boris Karpel, PhD, MPH (dec); Marcia Legro, PhD; and Daniel McDermott, MA. J.A.H., E.J.T., T.L.Z., C.K., G.P.M, C.J.S., and P.J.M. designed the study. Study coordination was provided by E.J.T. and C.K. Telephone interventions were performed by T.L.Z. and C.J.S. Data analysis was performed by E.J.T. and G.P.M. All authors contributed to writing the manuscript. This trial was registered with ClinicialTrials.gov (identifier: NCT01129141). This study was funded by VA Rehabilitation Research and Development Service (C7452I and C9247S). The authors have no conflicts of interest to disclose. Address for correspondence: James A. Henry, VA Portland Health Care System (NCRAR), 3710 SW US Veterans Hospital Rd, Portland, OR 97239, USA. E-mail: james.henry@va.gov Received March 25, 2017; accepted April 5, 2018. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and text of this article on the journal’s Web site (www.ear-hearing.com). Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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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. ACKNOWLEDGMENTS: The authors give special recognition for significant contributions to this study by Cody Blankenship, BS; Johnna Gonzalez, BA, MS, BSN; Samantha Boris Karpel, PhD, MPH (dec); Marcia Legro, PhD; and Daniel McDermott, MA. J.A.H., E.J.T., T.L.Z., C.K., G.P.M, C.J.S., and P.J.M. designed the study. Study coordination was provided by E.J.T. and C.K. Telephone interventions were performed by T.L.Z. and C.J.S. Data analysis was performed by E.J.T. and G.P.M. All authors contributed to writing the manuscript. This trial was registered with ClinicialTrials.gov (identifier: NCT01129141). This study was funded by VA Rehabilitation Research and Development Service (C7452I and C9247S). The authors have no conflicts of interest to disclose. Address for correspondence: James A. Henry, VA Portland Health Care System (NCRAR), 3710 SW US Veterans Hospital Rd, Portland, OR 97239, USA. E-mail: james.henry@va.gov Received March 25, 2017; accepted April 5, 2018. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and text of this article on the journal’s Web site (www.ear-hearing.com). Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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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. ACKNOWLEDGMENTS: The authors give special recognition for significant contributions to this study by Cody Blankenship, BS; Johnna Gonzalez, BA, MS, BSN; Samantha Boris Karpel, PhD, MPH (dec); Marcia Legro, PhD; and Daniel McDermott, MA. J.A.H., E.J.T., T.L.Z., C.K., G.P.M, C.J.S., and P.J.M. designed the study. Study coordination was provided by E.J.T. and C.K. Telephone interventions were performed by T.L.Z. and C.J.S. Data analysis was performed by E.J.T. and G.P.M. All authors contributed to writing the manuscript. This trial was registered with ClinicialTrials.gov (identifier: NCT01129141). This study was funded by VA Rehabilitation Research and Development Service (C7452I and C9247S). The authors have no conflicts of interest to disclose. Address for correspondence: James A. Henry, VA Portland Health Care System (NCRAR), 3710 SW US Veterans Hospital Rd, Portland, OR 97239, USA. E-mail: james.henry@va.gov Received March 25, 2017; accepted April 5, 2018. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and text of this article on the journal’s Web site (www.ear-hearing.com). Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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