Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jan 30, 2021
Date Accepted: Oct 5, 2021
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Internet-based audiologist-guided cognitive behavioral therapy tinnitus in the United States: A randomized controlled trial
ABSTRACT
Background:
Tinnitus is a symptom that can be very distressing due 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 is the tinnitus management strategy with the most evidence of effectiveness, but is rarely offered to those distressed by tinnitus. Provision of Internet-based cognitive behavioral therapy (ICBT) for tinnitus overcomes accessibility barriers, but is not at this time readily available in the US.
Objective:
The aim of this study was to investigate the efficacy of ICBT compared with weekly monitoring for the management of tinnitus in i) reducing tinnitus distress; ii) reducing tinnitus-related comorbidities including tinnitus cognitions, insomnia, anxiety, and depression and iii) assessing the stability of the intervention effects two-months post intervention.
Methods:
A two-arm randomized clinical trial comparing audiologist-guided ICBT (n = 79) against a weekly monitoring group (n =79) with a 2-month follow-up assessed the efficacy of ICBT. Eligibility included adults seeking help for bothersome tinnitus. Recruitment was online using an open-access website. Participants were randomized with a 1:1 allocation but blinding was not possible. The study was undertaken online by English or Spanish speakers. The primary outcome was a change in tinnitus distress as measured by the Tinnitus Functional Index. Secondary outcome measures included measures of anxiety, depression, insomnia, tinnitus cognitions, hearing-related difficulties, and quality of life.
Results:
ICBT led to a greater reduction in tinnitus distress (mean: 36.57, SD: 22:00) compared with weekly monitoring (mean: 46.31, SD: 20.63) with an effect size of d = 0.46 [0.14 to 0.77] using an intention-to-treat analysis. For the secondary outcomes there was a greater reduction in negative tinnitus cognitions and insomnia. There results remained stable over the 2-month follow-up period. No important adverse events were reported. There were 10 (16%) participants who withdraw, with compliance rates for questionnaire completion of 72% at T1, 57% at T2 and 42% at T3.
Conclusions:
This study is the first to evaluate and indicate the efficacy of audiologist-delivered ICBT in reducing tinnitus distress for a US population. It was also the first study to offer ICBT in Spanish to accommodate the large Hispanic population in the US. 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. Clinical Trial: Clinical Trials.gov: clinical trial NCT04004260. Registered on 2 July 2019
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