Guided Internet-based versus face-to-face clinical care in the management of tinnitus: Study protocol for a multi-centre randomised controlled trial

Beukes, Eldré W. and Baguley, David M. and Allen, Peter M. and Manchaiah, Vinaya and Andersson, Gerhard (2017) Guided Internet-based versus face-to-face clinical care in the management of tinnitus: Study protocol for a multi-centre randomised controlled trial. Trials, 18 (186). ISSN 1745-6215

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Official URL: http://dx.doi.org/10.1186/s13063-017-1931-6

Abstract

Background 3 Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive based therapy (iCBT) intervention for tinnitus was, therefore, developed for a UK population. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and the associated comorbidities such as insomnia, anxiety and depression. The aim of this phase III randomised control trial is to compare this new iCBT intervention to an established intervention, namely face-to-face clinical care for tinnitus. Methods This 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 two-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control will receive usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after being stratified for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a predefined non-inferiority margin. Discussion This protocol outlines phase III of a clinical trial comparing a new Internet-based intervention (iCBT) to that of established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as 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 registration: ClinicalTrials.gov NCT02665975; registered on 22/01/2016

Item Type: Journal Article
Keywords: service development, tinnitus managment, non-inferiority trial, tinnitus treatment, tinnitus distress, Internet-intervention, cognitive behavioural therapy
Faculty: Faculty of Science & Technology
Depositing User: Unnamed user with email eldre.beukes@anglia.ac.uk
Date Deposited: 26 Apr 2017 09:37
Last Modified: 26 Apr 2017 09:37
URI: http://arro.anglia.ac.uk/id/eprint/701718

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