Guided Internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial

Beukes, Eldre W. and Andersson, Gerhard and Allen, Peter M. and Manchaiah, Vinaya and Baguley, David (2018) Guided Internet-based versus face-to-face clinical care in the treatment of tinnitus: a multicentre randomized non-inferiority trial. JAMA Otolaryngology–Head & Neck Surgery . ISSN 2168-619X (In Press)

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Abstract

Importance: Accessible clinical care is not always available to those with distressing tinnitus. Internet-based cognitive behavioural therapy has potential to increase access to evidence-based tinnitus services. Research comparing the effectiveness of this intervention with face to face care is required.

Objective: To evaluate whether an Internet-based cognitive behavioural therapy intervention is at least as effective as established individualized face-to-face care in reducing tinnitus distress and tinnitus-related difficulties.

Design: A randomized, multi-centre, two-arm parallel group, non-inferiority trial with 2-month follow-up was run between October 2016 and July 2017. Participants were randomly assigned (1:1) to either intervention using variable permuted block sizes of four and six.

Setting: The experimental group received the Internet-intervention online while the active control undertook the usual face-to-face tinnitus care at one of three UK-based National Health Service hospitals.

Participants: Adults that had been referred to their local tinnitus clinics due to bothersome tinnitus, were invited to participate (n =374). 92 participants were randomized (experimental n = 46; control n= 46), of which 88 completed the immediate post-intervention assessment and 72 completed follow-up assessment measures.

Interventions: Participants were randomized to receive either 8 weeks of guided Internet-based cognitive behavioural therapy or 2-3 individualized face-to-face appointments in a tinnitus clinic.

Main Outcome measures: The primary outcome was a change in tinnitus distress (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.

Results: The between-group difference in the Tinnitus Functional Index scores at post-intervention of 5.19 (95% CI -4.17 to 14.53) and 5.18 (95% CI -4.17 to 14.53) at follow-up, fell within the non-inferiority margin of 13 points for the lower 95% confidence interval. For the secondary outcomes, only outcomes for insomnia fell outside the non-inferiority margin, at both post-intervention and follow-up, favouring the iCBT group.

Conclusions and Relevance: This is the first trial to compare an Internet-based intervention with standard individualized care for tinnitus. It demonstrates that both interventions were equally effective for reducing tinnitus distress and most tinnitus-related difficulties.

Trial Registration Clinicaltrials.gov: Identifier: NCT02665975

Item Type: Article
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Clinical Neuroscience
Depositing User: Eprints, Support
Date Deposited: 14 Sep 2018 10:23
Last Modified: 04 Feb 2019 11:40
URI: http://eprints.nottingham.ac.uk/id/eprint/54957

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