Abstract
BackgroundInnovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. population. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus.Methods/designThis will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin.DiscussionThis protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems.Trial registrationClinicalTrials.gov identifier: NCT02665975. Registered on 22 January 2016.
Highlights
Innovative strategies are required to improve access to evidence-based tinnitus interventions
This protocol outlines phase III of a clinical trial comparing a new Internet-based cognitive behavioural therapy (iCBT) with established face-to-face care for tinnitus
If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus
Summary
Innovative strategies are required to improve access to evidence-based tinnitus interventions. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. Beukes et al Trials (2017) 18:186 informational counselling, patient education, sound therapy, relaxation therapy, sleep management, the fitting of hearing aids or wearable sound generators, and the use of cognitive behavioural therapy (CBT). CBT has been shown to reduce the effects of a range of conditions, such as insomnia, anxiety, depression and pain [9] It is a practical solution-focused therapeutic approach aimed at modifying unhelpful thought patterns in order to promote tinnitus habituation [10]. Informational counselling and CBT were rated more effective than the use of sound therapy and fitting of hearing aids or sound generators by patients attending one audiology department in England [12]
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