Dataset Information

Long-term efficacy of audiologist-guided Internet-based cognitive behaviour therapy for tinnitus in the United States: A repeated-measures design.

ABSTRACT:

Objectives

This study investigated the long-term outcomes 1-year after undertaking an Internet-based cognitive behavioural therapy (ICBT) for tinnitus distress in a US population. Secondary aims were to identify the effects on additional difficulties associate with tinnitus and any unwanted events related to ICBT for tinnitus.

Methods

A repeated-measures design with 4 time points was used. Participants previously undertaking two randomized ICBT efficacy trials for tinnitus in the US were invited to participate. Of the 200 invited, 132 (66 %) completed the 1-year follow-up questionnaire. The primary outcome was a change in tinnitus distress from baseline at one year post-intervention, as assessed by the Tinnitus Functional Index. Secondary assessment measures were included for anxiety, depression, insomnia, hearing disability, hyperacusis, tinnitus cognitions and health-related quality of life.

Results

Undertaking ICBT for tinnitus led to significant improvements 1-year post-intervention for tinnitus severity, with a large effect size (d = 1.06; CI: 0.80 to 1.32). Medium effects were found for anxiety (d = 0.54; CI: 0.29 to 0.79), depression (d = 0.46; CI: 0.21 to 0.70), insomnia (d = 0.47; CI: 0.22 to 0.72), and tinnitus cognitions (d = 0.43, CI: 0.18 to 0.68). Small effect sizes were found for hearing disability, hyperacusis and health-related quality of life. Adverse events related to the intervention were only reported by 1 participant.

Conclusions

The benefits of audiologist-guided ICBT for tinnitus and tinnitus-related difficulties were maintained 1-year post-intervention with very few adverse events reported. Ways of disseminate evidence-based easily accessible interventions to the general population with bothersome tinnitus should be sought.

SUBMITTER: Beukes EW

PROVIDER: S-EPMC9637888 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Long-term efficacy of audiologist-guided Internet-based cognitive behaviour therapy for tinnitus in the United States: A repeated-measures design.

Beukes Eldré W EW Andersson Gerhard G Manchaiah Vinaya V

Internet interventions 20221030

<h4>Objectives</h4>This study investigated the long-term outcomes 1-year after undertaking an Internet-based cognitive behavioural therapy (ICBT) for tinnitus distress in a US population. Secondary aims were to identify the effects on additional difficulties associate with tinnitus and any unwanted events related to ICBT for tinnitus.<h4>Methods</h4>A repeated-measures design with 4 time points was used. Participants previously undertaking two randomized ICBT efficacy trials for tinnitus in the ...[more]

PMID: 36353148

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Project description:Background Patients often report that living with a condition such as tinnitus can be debilitating, worrying, and frustrating. Efficient ways to foster management strategies for individuals with tinnitus and promoting tinnitus self-efficacy are needed. Internet-based cognitive behavioral therapy (ICBT) for tinnitus shows promise as an evidence-based intervention in Europe, but is not available in the United States. The aim of this pilot study was to evaluate the feasibility of an ICBT intervention for tinnitus in the United States. Method This study reports the Phase 1 trial intended to support implementation of a larger randomized clinical trial (RCT) comparing ICBT to a weekly monitoring group. As a pilot study, a single-group pretest-posttest design was used to determine outcome potential, recruitment strategy, retention, and adherence rates of ICBT for tinnitus. The primary outcome was a change in tinnitus distress. Secondary outcome measures included measures of anxiety, depression, insomnia, tinnitus cognitions, hearing-related difficulties, and quality of life. Results Of the 42 screened participants, nine did not meet the inclusion criteria and six withdrew. There were 27 participants who completed the intervention, with a mean age of 55.48 (± 9.9) years. Feasibility was established, as a large pretest-posttest effect size of d = 1.6 was found for tinnitus severity. Large pretest-posttest effect sizes were also found for tinnitus cognitions and hearing-related effects, and a medium effect was found for insomnia and quality of life. Treatment adherence varied with a retention rate of 85% (n = 23) at post-intervention assessment and 67% (n = 18) for the follow-up assessment. Conclusions This pilot study supported the feasibility of ICBT for tinnitus in the United States. Ways of improving intervention retention and recruitment rates need to be explored in future ICBT studies. Protocol refinements that were identified will be implemented prior to further RCTs to investigate the efficacy of ICBT for tinnitus in the United States. Supplemental Material https://doi.org/10.23641/asha.15501135.

Project description:BackgroundTinnitus is a symptom that can be very distressing owing to hearing sounds not related to any external sound source. Managing tinnitus is notoriously difficult, and access to evidence-based care is limited. Cognitive behavioral therapy (CBT) is a tinnitus management strategy with the most evidence of effectiveness but is rarely offered to those distressed by tinnitus. The provision of internet-based CBT for tinnitus overcomes accessibility barriers; however, it is not currently readily available in the United States.ObjectiveThe aim of this study is to investigate the efficacy of internet-based CBT compared with that of weekly monitoring for the management of tinnitus in reducing tinnitus distress; reducing tinnitus-related comorbidities, including tinnitus cognitions, insomnia, anxiety, and depression; and assessing the stability of the intervention effects 2 months after the intervention.MethodsA 2-arm randomized clinical trial comparing audiologist-guided internet-based CBT (n=79) to a weekly monitoring group (n=79) with a 2-month follow-up assessed the efficacy of internet-based CBT. Eligible participants included adults seeking help for tinnitus. Recruitment was conducted on the web using an open-access website. Participants were randomized via 1:1 allocation, but blinding was not possible. The study was undertaken by English or Spanish speakers on the web. The primary outcome was a change in tinnitus distress as measured using the Tinnitus Functional Index. Secondary outcome measures included anxiety, depression, insomnia, tinnitus cognition, hearing-related difficulties, and quality of life.ResultsInternet-based CBT led to a greater reduction in tinnitus distress (mean 36.57, SD 22) compared with that in weekly monitoring (mean 46.31, SD 20.63; effect size: Cohen d=0.46, 95% CI 0.14-0.77) using an intention-to-treat analysis. For the secondary outcomes, there was a greater reduction in negative tinnitus cognition and insomnia. The results remained stable over the 2-month follow-up period. No important adverse events were observed. Further, 16% (10/158) of participants withdrew, with low overall compliance rates for questionnaire completion of 72.3% (107/148) at T1, 61% (91/148) at T2, and 42% (62/148) at T3.ConclusionsThis study is the first to evaluate and indicate the efficacy of audiologist-delivered internet-based CBT in reducing tinnitus distress in a US population. It was also the first study to offer internet-based CBT in Spanish to accommodate the large Hispanic population in the United States. The results have been encouraging, and further work is indicated in view of making such an intervention applicable to a wider population. Further work is required to improve compliance and attract more Spanish speakers.Trial registrationClinicalTrials.gov NCT04004260; https://clinicaltrials.gov/ct2/show/NCT04004260.

Project description:PurposeThe purpose of this study was to investigate the long-term outcomes 1 year after undertaking an audiologist-guided Internet-based cognitive behavioral therapy (iCBT) intervention for tinnitus. Secondary aims were to identify any predictors of outcome and whether there were any unwanted events related to undertaking iCBT for tinnitus.MethodParticipants who had previously undertaken a randomized iCBT efficacy trial for tinnitus were invited to participate. Of the 146 who were initially randomized for the efficacy trial, 104 participants completed the 1-year postintervention assessment measures. The primary outcome was a change in tinnitus distress as assessed by the Tinnitus Functional Index. Secondary assessment measures were included for insomnia, anxiety, depression, hearing handicap, hyperacusis, cognitive failures, and satisfaction with life. An intention-to-treat analysis using repeated-measures analysis of variance and hierarchical multiple regression was used for statistical analysis. Unwanted effects were categorized according to the unwanted events checklist.ResultsUndertaking iCBT for tinnitus led to significant improvements 1 year postintervention for tinnitus and related difficulties, for example, insomnia, anxiety, depression, hearing handicap, hyperacusis, and life satisfaction. The best predictors of improving tinnitus severity at 1-year postintervention were greater baseline tinnitus severity scores, reading more of the modules, and higher satisfaction with the intervention. Unwanted events were reported by 11% of the participants and were more likely to be reported by women than men. These events were related to worsening of symptoms, the emergence of new symptoms, negative well-being, and prolongation of treatment.ConclusionsThe clinical benefits of audiologist-guided iCBT for tinnitus and tinnitus-related difficulties were sustained 1 year postintervention. Predictors of outcome indicated that the intervention is applicable to a wide range of participants regardless of their demographic backgrounds. Attempts should be made to minimize unwanted events in subsequent trials.

Project description:Introduction: An internet-based cognitive behavioral therapy (ICBT) offers a way to increase access to evidence-based tinnitus care. To increase the accessibility of this intervention, the materials were translated into Spanish to reach Spanish as well as English speakers. A clinical trial indicated favorable outcomes of ICBT for tinnitus for the population of the United States. In view of later dissemination, a way to increase the applicability of this intervention is required. Such understanding is best obtained by considering the perspectives and experiences of participants of an intervention. This study aimed to identify the processes that could facilitate or hinder the clinical implementation of ICBT in the United States. Methods: This study evaluated the processes regarding enrolment, allocation, intervention delivery, the outcomes obtained, and the trial implementation. The study sample consisted of 158 participants who were randomly assigned to the experimental and control group. Results: Although the recruitment was sufficient for English speakers, recruiting the Spanish participants and participants belonging to ethnic minority groups was difficult despite using a wide range of recruitment strategies. The allocation processes were effective in successfully randomizing the groups. The intervention was delivered as planned, but not all the participants chose to engage with the materials provided. Compliance for completing the outcome measures was low. The personal and intervention factors were identified as barriers for the implementation whereas the facilitators included the support received, being empowering, the accessibility of the intervention, and its structure. Conclusion: An understanding regarding the factors contributing to the outcomes obtained, the barriers and facilitators of the results, engagement, and compliance were obtained. These insights will be helpful in preparing for the future dissemination of such interventions. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04004260. Registered on 2 July 2019.

Project description:ImportanceAccessible clinical care is not always available to individuals with distressing tinnitus. Internet-based cognitive behavioral therapy has the potential to increase access to evidence-based services that manage tinnitus. Research comparing the effectiveness of this internet-based intervention with face-to-face care is required.ObjectiveTo evaluate whether an internet-based cognitive behavioral therapy intervention is at least as effective as established individualized face-to-face clinical care in reducing tinnitus distress and tinnitus-related difficulties.Design, setting, and participantsA randomized, multicenter, 2-arm parallel group, noninferiority trial with 2-month follow-up was performed between October 4, 2016, and July 14, 2017. Invited to participate were 374 adults based in the United Kingdom who had been referred to their local tinnitus clinics because of bothersome tinnitus. The experimental group received the internet-based intervention online, and the active control group underwent the usual face-to-face tinnitus care at 1 of 3 UK-based National Health Service hospitals. Participants were randomly assigned (1:1) to either intervention using variable permuted block sizes of 4 and 6. Of 92 participants who were randomized (46 each in the experimental and control groups), 88 participants completed the assessment immediately after intervention and 74 participants completed the follow-up assessment.InterventionsParticipants were randomized to receive either 8 weeks of guided internet-based cognitive behavioral therapy or a mean of 2 to 3 individualized face-to-face appointments in a tinnitus clinic.Main outcomes and measuresThe primary outcome was a change in tinnitus distress (assessed by the Tinnitus Functional Index). Secondary assessment measures were included for insomnia, anxiety, depression, hearing disability, hyperacusis, cognitive failures, and satisfaction with life.ResultsOf 92 patients overall, 55 (60%) were men with a mean (SD) age of 52.96 (12.07) years and mean (SD) tinnitus duration of 6.54 (9.25) years. The between-group difference in the Tinnitus Functional Index scores after intervention were 5.18 (95% CI, -4.17 to 14.53) at the initial assessment and 5.52 (95% CI, -4.60 to 15.61) at follow-up; both differences were within the noninferiority margin of 13 points for the lower 95% CI. For the secondary outcomes, only outcomes for insomnia fell outside the noninferiority margin, both after intervention and at follow-up, favoring internet-based cognitive behavioral therapy.Conclusions and relevanceThis is the first trial, to our knowledge, to compare an internet-based intervention with standard individualized face-to-face care for tinnitus. It revealed that both interventions are equally effective for reducing tinnitus distress and most tinnitus-related difficulties.Trial registrationClinicalTrials.gov identifier: NCT02665975.

Dataset Information

Long-term efficacy of audiologist-guided Internet-based cognitive behaviour therapy for tinnitus in the United States: A repeated-measures design.

Objectives

Methods

Results

Conclusions

Publications

Long-term efficacy of audiologist-guided Internet-based cognitive behaviour therapy for tinnitus in the United States: A repeated-measures design.

Similar Datasets

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