Development and technical functionality of an Internet-based intervention for tinnitus in the UK

Purpose: Creative approaches to improve access to evidence-based tinnitus treatments are required. The purpose of this study was to develop an Internet-based cognitive behavioural therapy (iCBT) intervention, for those experiencing tinnitus in the United Kingdom(UK). Furthermore, it aimed, through technical functionality testing, to identify specific aspects of the iCBT that require improving. Method: An innovative iCBT intervention for treating tinnitus in the UK has been developed using a cognitivebehavioural theoretical framework. This iCBT was evaluated by two user groups during this developmental phase. Initially, five expert reviews evaluated the intervention, prior to evaluation by a group of 29 adults experiencing significant levels of tinnitus distress. Both groups evaluated iCBT in an independent measures design, using a specifically designed satisfaction outcome measure. Results: Overall, similar ratingswere given by the expert reviewers and adults with tinnitus, showing a high level of satisfaction regarding the content, suitability, presentation, usability and exercises provided in the intervention. The iCBT intervention has been refined following technical functionality testing. Conclusions: Rigorous testing of the developed iCBT intervention has been undertaken. These evaluations provide confidence that further clinical trials can commence in the UK, to assess the feasibility and effectiveness of this iCBT intervention for tinnitus

Audiologist-guided internet-based cognitive behavior therapy for adults with tinnitus in the United Kingdom: a randomized controlled trial

Objectives: Specialist tinnitus services are in high demand as a result of the negative effect tinnitus may have on quality of life. Additional clinically and cost-effective tinnitus management routes are needed. One potential route is providing Cognitive Behavioural Therapy for tinnitus via the Internet (iCBT). This study aimed to determine the efficacy of guided iCBT, using audiological support, on tinnitus distress and tinnitus-related comorbidities, in the United Kingdom. A further aim was to establish the stability of intervention effects 2-months postintervention. The hypothesis was that iCBT for tinnitus would be more effective at reducing tinnitus distress than weekly monitoring.Design: A randomized, delayed intervention efficacy trial, with a 2-month follow-up was implemented to evaluate the efficacy of iCBT in the United Kingdom. Participants were randomly assigned to the experimental (n = 73) or weekly monitoring control group (n = 73) after being stratified for tinnitus severity and age. After the experimental group completed the 8-week long iCBT intervention, the control group undertook the same intervention. Intervention effects were, therefore, evaluated in two independent groups at two time points. The primary outcome was a change in tinnitus distress between the groups as assessed by the Tinnitus Functional Index. Secondary assessment measures were included for insomnia, anxiety, depression, hearing disability, hyperacusis, cognitive failures, and satisfaction with life. These were completed at baseline, postintervention, and at a 2-month postintervention follow-up.Results: After undertaking the iCBT intervention, the experimental group had a greater reduction in tinnitus distress when compared with the control group. This reduction was statistically significant (Cohen's d = 0.7) and was clinically significant for 51% of the experimental group and 5% of the control group. This reduction was evident 4 weeks after commencing the iCBT intervention. Furthermore, the experimental group had a greater reduction in insomnia, depression, hyperacusis, cognitive failures, and a greater improvement in quality of life, as evidenced by the significant differences in these assessment measures postintervention. Results were maintained 2 months postintervention.Conclusions: Guided (using audiological support) iCBT for tinnitus resulted in statistically significant reductions in tinnitus distress and comorbidities (insomnia, depression, hyperacusis, cognitive failures) and a significant increase in quality of life. These effects remained stable at 2-months postintervention. Further trials to determine the longer term efficacy of iCBT to investigate predictors of outcome and to compare iCBT with standard clinical care in the United Kingdom are required

Effectiveness of Guided Internet-Based Cognitive Behavioral Therapy vs Face-to-Face Clinical Care for Treatment of Tinnitus: A Randomized Clinical Trial

Importance: Accessible 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. Objective: To 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 Participants: A 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. Interventions: Participants 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 Measures: The 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. Results: Of 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 Relevance: This 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