Internet-based Versus Face-to-face Clinical Care for Tinnitus: A Multi-study Randomised Control Trial
Phase: NA
Conditions: Tinnitus
Sponsor: Anglia Ruskin University

 
 
 
 
 
 
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Study Protocol        Version 4 
IRAS identification number:  195565  Created: 10 March 2016. Amended:  10 July 2016   
Author: Eldré Beukes 
PROTOCOL 
Internet-based intervention versus face-to-face clinical care for 
tinnitus: A randomized control trial 
Clinical Trials registration number: NCT02665975 
Principle Investigator: Eldré Beukes  (eldre.beukes@anglia.ac.uk) 
Ethical approval: Cambridge South Research Ethics Committee, 16/EE/0148. HRA 
approval under IRAS project identification number 195565 
Sponsor: Anglia Ruskin University 
Grant: British Society of Audiology Applied Research Grant Fund 
Clinical Sites: Norfolk and Norwich University Hospitals NHS Foundation Trust 
Hinchingbrooke Health Care HNS Trust 
Milton Keynes University Hospital NHS Foundation Trust 
Date of protocol version:10 Juy 2016 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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Study Protocol        Version 4 
IRAS identification number:  195565  Created: 10 March 2016. Amended:  10 July 2016   
Author: Eldré Beukes 
INTRODUCTION 
Tinnitus places a burden on healthcare systems, leaving many people with distressing 
tinnitus without appropriated care. Innovative management strategies are required to 
improve access to evidence-based treatments. A guided Internet-based intervention for 
tinnitus was therefore developed (iCBT) for a UK population. Initial clinical trials 
indicated that iCBT in the UK is effective at reducing tinnitus distress and associated 
comorbidities. The aim of this randomized control trial is to compare this iCBT 
intervention to that of standard tinnitus care provided face-to-face in clinical settings, 
for reducing tinnitus distress and associated problems.  
OBJECTIVES 
The primary aim of this study is to evaluate the effectiveness of iCBT for tinnitus 
distress, compared to standard care. The key secondary objective is to determine the 
effectiveness of iCBT for tinnitus related comorbidities, compared to standard care. 
Further objectives are to determine the longer-term effects of iCBT compared to that of 
standard care, two months post-intervention and establish if there are any predictor 
variables associated with outcomes for iCBT compared to those for standard care. 
STUDY DESIGN 
A randomised, multi-centre, two-arm parallel group, non-inferiority trial with a 
sequential adaptive design and a two-month follow-up will be followed. The 
experimental group will receive eight weeks of guided internet-delivered treatment 

 
 
 
 
 
 
3
Study Protocol        Version 4 
IRAS identification number:  195565  Created: 10 March 2016. Amended:  10 July 2016   
Author: Eldré Beukes 
(iCBT) as seen in Figure 1. The control group will receive a standard individual face-
to-face audiological care. The hypothesis is that there will be no difference in outcomes 
for the treatment and control groups. These groups will be followed prospectively for 
two months, to establish the maintenance and effectiveness of both treatments on 
tinnitus distress.  
 

 
 
 
 
 
 
4
Study Protocol        Version 4 
IRAS identification number:  195565  Created: 10 March 2016. Amended:  10 July 2016   
Author: Eldré Beukes 
Randomisation 
Those interested complete an online 
and telephone screening  (T0)
T1: Post-intervention assessment online and 
on the telephone
T2  :  Follow-up online assessment 2 months 
later
Enrollment
Allocation
Follow-up
Analysis
Analysed n= 
Experimental group: iCBT 
Group n=65
Control group:
F2F group n=65
Assessed for eligibility for a standard tinnitus 
consultation by Audiologist/ ENT at each hospital 
site. Informed of study and invited to participate
 
Figure 1: Trial design 
PARTICIPANTS 
Sample size 
 

 
 
 
 
 
 
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Study Protocol        Version 4 
IRAS identification number:  195565  Created: 10 March 2016. Amended:  10 July 2016   
Author: Eldré Beukes 
Sample size calculations have indicated that 65 participants are required per group. 
Estimated recruitment is 50 participants from both Norfolk and Norwich University 
Hospital and Hinchingbrookes Hospital and 30 from Milton Keynes University 
Hospital. 
 
ENROLLMENT 
All adult patients referred to the three participating Tinnitus Clinics during the 
recruitment period, who meet inclusion criteria, will be invited to participate.  It is 
estimated that recruitment will occur over a two-month period. Eligibility is determined 
on the basis of the following criteria: 
 
Inclusion Criteria 
i) Having undergone a clinical evaluation by either their ENT Specialist or the 
Audiologist at participating sites, to rule out the presence of serious auditory 
pathology 
ii) Experiencing tinnitus distress deemed to require a referral to the tinnitus clinic 
by the referring ENT Specialist or Audiologist 
iii) Aged 18 years and over, living in the UK with the ability to read and type in 
English 
iv) Regular access to a computer and the internet and the ability to use these 
 
Exclusion Criteria 

 
 
 
 
 
 
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Study Protocol        Version 4 
IRAS identification number:  195565  Created: 10 March 2016. Amended:  10 July 2016   
Author: Eldré Beukes 
i) 
Reporting any major medical or psychiatric conditions 
ii) 
Undergoing any tinnitus therapy concurrently to partaking in this study 
 
Withdrawal 
Participants will be informed of the right to withdraw without penalty. Statistical 
analysis will be done on an intention to treat basis unless they request all data removal.  
SCHEDULE 
Recruitment will be aimed to start in August, with initial participants from the face-to-
face interventions to be seen between September 2016-January 2017 for their initial 
and follow-up appointments. Study close out will be two months after their intervention 
ended, which is estimated to be by April 2017. A broad outline of responsibilities is 
given in Table 1. 
 
Table 1: Responsibilities of clinical sites and PI 
Recruitment and distributing PIS 
Clinical sites 
Providing information about the study 
Principle investigator (PI) 
Study consent 
Online (PI) 
Assessment 
Online. PI to pass on results to clinical 
sites 
Initial 
telephonic 
contact 
with 
participants 
PI 
Randomisation and allocation 
PI and PI to pass on allocation to clinical 
sites 
Triage for the need for amplification 
Clinical sites. Appointments to be 
considered on an individual basis 

 
 
 
 
 
 
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Study Protocol        Version 4 
IRAS identification number:  195565  Created: 10 March 2016. Amended:  10 July 2016   
Author: Eldré Beukes 
iCBT group: 8 weeks treatment 
PI 
Face to face standard care group 
treatment and appointment worksheet 
completion 
Clinical sites 
Post-intervention outcome measures 
Online. PI to pass on results to clinical 
sites 
Post treatment phone call 
PI 
Follow up assessment  
Online. PI to pass on results to clinical 
sites 
 
Data management 
All personal data will be kept confidentiality. Each participant will be assigned a 
random user code (four digits followed by four letters), this is used by therapists to 
identify the participant during treatment. Secure communications to take place between 
clinicians and the therapist via the tackling tinnitus website, for which login details have 
been provided. All personal participant information to be saved safely according 
clinical sites IT policies.