Dismantling internet-based cognitive behavioral therapy for tinnitus. The contribution of applied relaxation: A randomized controlled trial

Abstract

Background Internet-based cognitive behavioral therapy (ICBT) for tinnitus is an evidence-based intervention. The components of ICBT for tinnitus have, however, not been dismantled and thus the effectiveness of the different therapeutic components is unknown. It is, furthermore, not known if heterogeneous tinnitus subgroups respond differently to ICBT. Aims This dismantling study aimed to explore the contribution of applied relaxation within ICBT for reducing tinnitus distress and comorbidities associated with tinnitus. A secondary aim was to assess whether outcomes varied for three tinnitus subgroups, namely those with significant tinnitus severity, those with low tinnitus severity, and those with significant depression. Methods A parallel randomized controlled trial design ( n = 126) was used to compare audiologist-guided applied relaxation with the full ICBT intervention. Recruitment was online and via the intervention platform. Assessments were completed at four-time points including a 2-month follow-up period. The primary outcome was tinnitus severity as measured by the Tinnitus Functional Index. Secondary outcomes were included for anxiety, depression, insomnia, negative tinnitus cognitions, health-related quality of life, hearing disability, and hyperacusis. Treatment engagement variables including the number of logins, number of modules opened, and the number of messages sent. Both an intention-to-treat analysis and completer's only analysis were undertaken. Results Engagement was low which compromised results as the full intervention was undertaken by few participants. Both the ICBT and applied relaxation resulted in large reduction of tinnitus severity (within-group effect sizes d = 0.87 and 0.68, respectively for completers only analysis), which were maintained, or further improved at follow-up. These reductions in tinnitus distress were greater for the ICBT group, with a small effect size differences (between-group d = 0.15 in favor of ICBT for completers only analysis). Tinnitus distress decreased the most at post-intervention for those with significant depression at baseline. Both ICBT and applied relaxation contributed to significant reductions on most secondary outcome measures, with no group differences, except for a greater reduction of hyperacusis in the ICBT group. Conclusion Due to poor compliance partly attributed to the COVID-19 pandemic results were compromised. Further studies employing strategies to improve compliance and engagement are required. The intervention's effectiveness increased with initial level of tinnitus distress; those with the highest scores at intake experienced the most substantial changes on the outcome measures. This may suggest tailoring of interventions according to tinnitus severity. Larger samples are needed to confirm this.

The Impact of COVID-19 and the Pandemic on Tinnitus: A Systematic Review

“…Most importantly, digital therapeutical approaches should be prioritized to provide psychological interventions to those suffering from tinnitus and not able to access services due to demand on healthcare as well as not having access to services such as these, which are seen as low priority by hearing healthcare professionals during the pandemic [64]. Several studies across the globe have demonstrated the efficacy and effectiveness of Internet-based cognitive behavioral therapy (ICBT) for tinnitus [65][66][67][68], although not many programs are available for individuals. For this reason, clinicians and policymakers need to consider alternative ways of offering tinnitus services using teleaudiology approaches.…”

Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States

“…This study was a process evaluation of an RCT of ICBT for tinnitus conducted between March 2020 and July 2020. The process evaluation was conducted in parallel to a clinical trial that investigated the efficacy of ICBT for tinnitus in the United States ( 23 ). The participants were randomized with a 1:1 allocation ratio to the experimental group to receive ICBT for 8 weeks, or the control group who received the intervention after a delay of 8 weeks during which time they were monitored weekly.…”

“…The participants were asked to read the modules weekly and ideally spend at least 10 min each day practicing the suggested strategies. The intervention specifically targeted reducing the activity limitations and participation restrictions and included applied relaxation due to the importance of this aspect in tinnitus managment ( 40 ). Both the groups received the same intervention, only the timings regarding receiving the intervention varied.…”

“…To further increase the availability of CBT, the intervention was adapted for the population of the United States ( 19 ) and also translated into Spanish to reach the Spanish and English speakers ( 20 ). As a pilot study indicated the feasibility of the intervention ( 21 , 22 ), a randomized clinical trial (RCT) was undertaken ( 21 , 23 ). The studies in the United Kingdom were the first in which the ICBT was delivered by an audiologist ( 16 – 18 ).…”

“…The research objective of the present study was to identify the processes that could facilitate or hinder the clinical implementation of ICBT for tinnitus in the United State ( 23 ). This was done by considering the full trial implication from the recruitment to post-intervention follow-up.…”