CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom: A Randomise Controlled Trial
Phase: NA
Conditions: Tinnitus
Sponsor: Anglia Ruskin University

1 
 
Study protocol: 
 
Title of Project: Internet-based cognitive behaviour therapy for adults with 
tinnitus in the United Kingdom 
Trial registration: ClinicalTrials.gov; NCT02370810, date 05/03/2015 
Ethical approval: Research Ethics Committee (REC) of Anglia Ruskin University 
(FST/FREP/14/478) 
Author: Eldré W. Beukes,  
 
Date: 17 September 2015 
 
 
 
 

2 
 
INTRODUCTION 
Tinnitus is one of the most distressing and debilitating hearing-related symptoms.1 Unwanted 
sounds, such as ringing or buzzing are experienced, in the absence of a concurrent external 
sound source.2 It is highly prevalent, affecting between 10-15% of adults in the UK, with an 
increased prevalence in older adults.3  
Despite much research, medical treatments are usually ineffective at reducing tinnitus and a 
cure remains to be found.4 Tinnitus is therefore managed as a chronic condition, thereby adding 
strain on current healthcare systems.5 For some, experiencing tinnitus can result in a complex 
set of complaints.6 As there is a strong relationship between tinnitus and hearing difficulties, 
this adds to the distress experienced.7 In addition to the possible adverse effects on daily life, 
such as the impact on sleep, mood and concentration, there may also be a number of indirect 
psychological and psychosocial effects, including depression and anxiety.8 These concurrent 
physical and psychological effects add to the healthcare burden, as further input may be 
required from various health professionals.9  
 
When it comes to tinnitus management strategies, there is a low evidence-base for many 
practices.10 Good Practice Guidelines for tinnitus management were set by the Department of 
Health in the UK in 2009.11 Hoare and colleagues,12 found poor guideline adherence, unequal 
access to care, lack of standardization and limited use of psychological interventions for 
tinnitus. Innovative ways of addressing these issues in the UK are therefore required.  
 
Cognitive Behavioural Therapy (CBT) is a technique, which reduces the distress associated 
with tinnitus,13 and is one of the tinnitus treatment options with the most evidence of 
effectiveness.14 It has been shown to add to the efficacy of Audiology/ENT approaches to 
treatment.15 It is however, rarely offered in clinical practice,16 particularly in the UK.17 This is 
largely due to a shortage of those with appropriate CBT training, such as Psychologists who 
are audiologically literate, and willing to manage tinnitus.18   
 
To provide an accessible evidence-based tinnitus treatment, an internet-based, CBT 
intervention (iCBT) was developed by Andersson and colleagues,19 and results of their initial 
Randomized Control Trial (RCT) showed promising effects. Following intervention 
improvements, further studies, run in Sweden and Germany, indicated similar results to face-

3 
 
to-face group CBT.20,21 A further RCT in Australia by Abbott and colleagues,22 found results 
of iCBT did not show any statistically significant benefit over a information-only control 
program (without CBT content). In addition, the attrition rate was higher in the iCBT group. 
This poses questions regarding whether the structure and presentation of the intervention 
requires updating to improve overall outcomes. If iCBT for tinnitus distress was feasible in the 
UK it may bridge a gap for those who have not been able to access appropriate tinnitus services. 
It could furthermore reduce the burden on the healthcare system for those who do not require 
supra-specialist support.  
 
A study to determine whether iCBT could be a suitable intervention is therefore of value. The 
aim of this study is to further our knowledge of the feasibility and effectiveness of iCBT for 
tinnitus management in the UK. This research is timely and in line with two of the tinnitus 
research priorities recommended by the James Lind Alliance,4 namely: research investigating 
which management strategies are more effective than the usual model of audiological care in 
improving outcomes for people with tinnitus and research determining whether CBT, delivered 
by audiology professionals, is effective for people with tinnitus. 
 
The research objectives for this study are therefore as follows: 
1. To establish the feasibility of using iCBT for tinnitus distress, as an intervention for 
adults with tinnitus in the UK 
2. To evaluate the effectiveness of iCBT for tinnitus distress in reducing the impact 
associated with tinnitus for adults in the UK. 
3. To ascertain predictors of outcome for whom this iCBT intervention is a suitable 
intervention 
4. To determine the longer term effects of iCBT, 12 months post-intervention 
 
METHODS 
Study design 
This will be an internet-based study run in the UK.  This intervention study will be implemented 
as a two-armed RCT, with a one-year follow-up, to evaluate the effectiveness iCBT on tinnitus 
distress. An effectiveness trial has been selected, to increase the extent to which the study 
results can be generalised and be used to identify for which subgroups of tinnitus sufferers this 
is a suitable intervention. A delayed treatment design using a weekly check-in control (WCI) 
group will be used, as shown in Figure 1. The objective is to test the superiority of the 

4 
 
intervention, with the hypothesis that the treatment group will perform better than the weekly 
check-in group. These groups will be followed prospectively for 1 year, to establish the long-
term effectiveness of the intervention programme.  
 
This study design is described using the Standard Protocol Items, Recommendations for 
Interventional Trials (SPIRIT) checklist.23,24  and has been registered with Clinical Trials.gov: 
NCT02370810, date 05/03/2015 
 

5 
 
Excluded n=
(reasons)
Randomisation (T0)
Telephone screening 
Excluded n=
(reasons)
T1: Post-intervention assessment (8 weeks)
T2  :  Post intervention assessment (16 weeks) 
Enrollment
Allocation
Follow-up
Analysis
Analysed n= 
Excluded n=
(reasons)
Treatment Group n=70
8 week iCBT intervention 
 Not completed  n= 
Weekly Check in Group n=70
Weekly THI-S completion
 Not completed  n= 
Weekly check in group:
8 week iCBT intervention  
Assessed for eligibility (n= ): online screening and 
baseline measurements(-T1)
Tx :1 year month post intervention assessment and close 
out
 
 
Study groups 
There will be two study groups. The Test Group will receive the eight-week long iCBT 
treatment following baseline measurements and allocation (after T0). The weekly check-in 
Control Group will be monitored during the active treatment phase by means of the Tinnitus 

6 
 
Handicap Inventory- Screening Version.25 but will have no other contact or involvement in the 
study during this period. The control group will undergo the same iCBT intervention once the 
treatment group finishes the programme (after T1).  
 
Inclusion Criteria 
 
A clinical evaluation prior to partaking in the study is desirable, to rule out the presence of a 
serious auditory pathology or associated psychological problem, which may be related to 
having tinnitus.26    If there are any concerns, a letter will be provided for participants to take 
to their General Practitioner, for further management.  
 
Participant’s eligibility for the study is as follows: 
i) 
Aged 18 years and over living in the UK 
ii) 
The ability to read and type in English  
iii) 
No barriers to using a computer (e.g. significant fine motor control or visual 
problems) 
iv) 
Internet and e-mail access, and the ability to use these 
v) 
Commitment to completing the programme  
vi) 
Completion of the online screening and outcome questionnaires 
vii) 
Agreeing to participate in either group and be randomized to one of these groups 
viii) 
Understanding and working towards the end goal of reducing the impact and 
distress of tinnitus, although the strength of the tinnitus may remain the same 
ix) 
Be available for 12 months after starting the study to complete a 1 year follow-up 
questionnaire 
x) 
Suffering with tinnitus for a minimum period of 3 months 
xi) 
Tinnitus outcome measure scores indicating the need for tinnitus care (26 or above 
on the Tinnitus Functional Index)27  
 
Exclusion Criteria 
i) 
Reporting any major medical or psychiatric conditions 
ii) 
Reporting pulsatile, objective or unilateral tinnitus, which have not been 
investigated medically 
iii) 
Tinnitus as a consequence of a medical disorder, still under investigation 
iv) 
Undergoing any tinnitus therapy concurrently to partaking in this study 

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A two-staged selection procedure will be followed: 
i) 
An online screening questionnaire, which includes health and mental health related 
questions 
ii) 
A telephone interview, during which the researcher will re-check eligibility and 
provide the opportunity for potential participants to ask any questions related to the 
study.  
 
Recruitment 
Recruitment will be UK wide, using as many different forms as possible to achieve adequate 
participant enrolment. Information about the study will be advertised at tinnitus and hearing-
related support groups and charities, in their newsletters and drop in centres. It will furthermore 
be advertised in Audiology Departments and by using social media. Talks to professionals, 
such as ENT Consultants and Audiologists, will also be given to introduce the study and aid 
recruitment. Those interested can obtain information and register interest on the study website.  
 
Sample size 
Sample size estimation was calculated using Power and Sample Size Programme, version 3.1.2 
and based on achieving a clinically relevant change of 13 points (std dev 24.7) in the main 
outcome measure to be used for this study; the Tinnitus Functional Index.27 This indicated 30 
participants were required per group; with an allocation ratio of 1:1, to achieve a two-sided 
significance level of 0.05 and effect size of 0.8. As these calculations are based on a fairly new 
outcome measure and there may be dropouts, an additional 40 participants will be added, to 
ensure enough valid data to draw conclusions from.  Therefore, 70 participants will be assigned 
to the experimental group, and 70 participants to the control group. This is roughly in line with 
the sample sizes used in similar studies.  
 
Allocation 
Participants will be randomly assigned to either control or experimental group with a 1:1 
allocation using a computer generated randomization schedule (http://www.randomizer.org/) by 
an independent researcher. To prevent an unequal distribution among groups, participants will 
be pre-stratified on the factors of age (<= 60 or >60 year) and Tinnitus severity (TFI <= 50 or 
>50). Furthermore, block randomization, with blocks of four, will be applied to ensure equal 
groups sizes within each stratum.  

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Following allocation participants will be contacted by telephone, to provide the opportunity to 
discuss the aspects of the study and answer any questions. This initial contact has been found 
to be valuable to ensure participants are motivated to complete the treatment.20  
 
Intervention 
The intervention to be followed, is built on an internet-based CBT self-help programme (iCBT) 
for reducing tinnitus distress developed by Andersson and colleagues.19 It incorporates a 
combination of a cognitive rational,28 and a learning theory approach.29 The original 
intervention was largely text based. The present authors have redesigned and modified the 
intervention content and presentation, to have an interactive e-learning version, as shown in 
Figure 2. This will ensure the intervention is visually stimulating, engaging and responsive to 
participant’s progress.  
 
The intervention consists of fixed and optional modules, covered over a period of 8 weeks, as 
shown in Table 1. The modules contain a mixture of information, videos, quizzes, diagrams, 
suggested techniques to apply to daily life, worksheets to keep track of progress, solutions for 
common problems and downloadable information.   
 
The iCBT intervention will be delivered on a secure web platform, for which participants will 
receive password protected login information.   
 
 
 
 
Table 1: The components of the iCBT intervention 
Week 
Module 
Explanation 
Application 
1 
About this treatment 
Introduction to the modules 
Reading 
 
Tinnitus overview 
In depth information   
Quizzes 
2 
Relaxation: step 1 
Deep relaxation  
10-15 min, twice/day  
Identifying 
negative 
thoughts 
The link between thoughts and 
feelings  
Writing down thoughts 
*Sound enrichment 
Using background sounds 
Applying external sounds  
3 
 Relaxation: step 2 
Diaphragmatic breathing 
5-7 min, twice/day 
Cognitive restructuring  
Analysing thoughts 
Writing down situation, 
thoughts, feelings 
*Sleep guidelines 
Various Techniques 
Chose 
and 
apply 
techniques 

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4 
Relaxation: step 3 
Entire body relaxation 
2-3 min, twice/day 
Positive imagery 
Use to enhance relaxation  
Twice/day after relaxation 
*Concentration tips 
Techniques discussed 
Engage 
in 
mentally 
engaging activities 
5 
Relaxation: step 4 
Rapid relaxation 
20-60 sec, 5-10 times/day  
Focus exercises 
Mindful awareness 
Twice/day after relaxation 
*Sensitivity to sound 
Gradual exposure  
Listen to non-damaging, 
non-annoying sounds 
6 
Relaxation: step 5 
Rapid 
relaxation 
in 
more 
difficult situations 
30-60 sec, 10-15 times/day 
Reinterpretation 
of 
tinnitus 
Change 
negative 
tinnitus 
associations  
Writing 
about 
tinnitus 
thoughts 
* Hearing tactics 
Communication advice 
Follow advice 
7 
Relaxation: step 6 
Making relaxation part of daily 
routines and habits 
Rapid relaxation 10-20 
times/day 
Exposure to tinnitus 
Decrease negative emotions and 
avoidance of tinnitus  
Actively listen to tinnitus 
for 5-10 min, once/day, 
after relaxation 
8 
Key points summary  
Highlighting key concepts  
Online quiz 
Future planning 
Maintenance 
and 
relapse 
prevention 
Making a plan to use tools 
in daily life 
Optional modules are marked with an * 
 
Monitoring progress 
Participants will be minimally guided via a secure online messaging system. This therapeutic 
alliance will allow for feedback and assistance if participants have any difficulties and has 
shown better outcomes than internet interventions without this communication.30 The clinician 
will contact any participants who have not completed their weekly progress worksheets to 
ensure they are assisted as required. In these worksheets, participants record details about 
when, where, and for how long they practiced the suggested techniques and how effective these 
techniques were.  
 
As tinnitus therapy is largely delivered by the audiology community in the UK, an experienced 
Audiological Scientist, registered with the Health Professions Council, will therefore undertake 
the role of supporting the participants, to maintain consistency with the standard approach. 
Support will however be provided by a Psychologist, with experience in iCBT interventions 
and a protocol for dealing with different situations will be used.  
 

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Assessment 
The assessment battery will consist of a screening eligibility questionnaire and relevant self-
reported outcome measures, related to areas which may be affected by tinnitus. Outcome 
measures for tinnitus severity, hearing handicap, insomnia, cognitive functioning, hyperacusis, 
anxiety, depression and life satisfaction were therefore selected. Careful consideration was 
given to ensure each questionnaire was as brief as possible and had good psychometric 
properties as seen in Table 2.  The outcomes were furthermore selected to be aligned with the 
International Classification of Functioning, Disability and Health (ICF)31 framework on the 
domains of activity limitation and participation restriction.  
 
 
 
The assessment battery and outcome measures will include: 
 
1. 
Eligibility screening: A range of demographic, tinnitus specific and health related 
questions will be asked to determine demographic variability and study eligibility. 
Open-ended questions asking about positive and negative experiences related to 
having tinnitus will also be incorporated. 
 
2. 
The main outcome measures: The Tinnitus Functional Index (TFI), has been 
selected to determine tinnitus severity, as it is validated for assessing responsiveness 
to treatment both for scaling the severity and negative impact of tinnitus and for 
measuring treatment-related changes in tinnitus.27 The TFI was specifically 
designed to measure the effectiveness of interventions, a feature lacking in previous 
tinnitus outcome measures.32 Due to its validation for assessing treatment 
responsiveness, it was chosen above some other more established questionnaires, 
such as the Tinnitus Handicap Inventory.33 
 
3. 
Secondary outcome measures: 
 
3.1 The Tinnitus Handicap Inventory -Screening Version (THI-S),25 will be used as 
a concise outcome measure, particularly to monitor tinnitus handicap on a weekly 
basis during the active treatment phase.  

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3.2 As there is a strong relationship between tinnitus and hearing difficulties,7 the 
Hearing Handicap Inventory for Adults-Screening Version (HHIA-S),34 will be 
administered to quantify perceived hearing handicap. It includes both emotional and 
social/situational subscales.  
3.3 As sleep disturbances are commonly associated with tinnitus,35 the Insomnia 
Severity Index (ISI)36 will be included. This questionnaire assesses the nature, 
severity, and impact of insomnia by assessing sleep duration, sleep quality, the 
negative impact on daily functioning and psychological well-being.  
3.4 As having tinnitus may disrupt cognitive functioning,37 the Cognitive Failures 
questionnaire (CFQ)38 will be included. It was designed to assess proneness to 
committing cognitive slips and errors in the completion of everyday tasks such as 
failures in perception, memory, and motor function.  
3.5 As there is a high comorbidity of  hyperacusis (a reduced tolerance of everyday 
sounds)39 in those with tinnitus,40 the Hyperacusis Questionnaire41 will be 
administered.  Although further work on the structure of this questionnaire is 
required to establish its reliability for measuring hyperacusis in the tinnitus research 
population, the scores obtained will be useful to compare pre and post-intervention 
changes. 
 
3.6 As anxiety and depression are common comorbid conditions in individuals with 
tinnitus,6 the Patient Health Questionnaire (PHQ-9),42 to measure depression 
severity and the Generalised Anxiety Disorder (GAD-7),43 to assess anxiety severity 
will be administered. 
3.7 To include a measure of quality of life, the Satisfaction with Life Scales,44 
assessing global life satisfaction will be used. For the purpose of this study, it was 
felt that the questions in this scale were more appropriate than those of longer 
quality of life measures, which include areas of mobility and self-care, which are 
not directly targeted by this study.  
 
Permission has been obtained to use the questionnaires, for which it is required, such as the 
TFI.  
Table 2: Known psychometric properties of the questionnaires to be administered at some 
point during the study 
 

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Measure and validation reference 
Items 
Scale used 
Internal 
consistency 
(Cronbach’s alpha) 
Tinnitus Functional Index27 
25 
1-10 
0.97 
Tinnitus Handicap Inventory-Screening25  
10 
1-3 
0.87 
Hearing Handicap Inventory: Screening34 
10 
1-3 
0.93 
Insomnia Severity Index36 
7 
0-4 
0.74 
Cognitive Failures Questionnaire38  
25 
0-4 
0.89 
Hyperacusis Questionnaire41 
14 
0-4 
0.66-0.68 
Patient Health Questionnaire42 
9 
0-3 
0.83 
Generalised Anxiety Disorder45 
7 
0-3 
0.89 
Satisfaction with Life Scales44 
5 
1-7 
0.87 
 
 
 
Questionnaire delivery 
The format of the questionnaire delivery will remain consistent throughout the study using 
online questionnaires. Not all questionnaires to be used have been validated for internet use. 
Previous research has found comparable results in terms of psychometric properties between  
computer and paper questionnaire delivery, with high test-retest reliability and completion rate 
on the internet.46,47 See Table 3 for the schedule of outcome measure delivery.  
 
 
Process Evaluation 
An intervention, such as iCBT is known as a ‘complex intervention’ as it combines different 
components but does not involve drugs or surgical procedures.48 To fully investigate the 
different aspects of this complex intervention, we will be exploring the processes involved in 
implementing the iCBT intervention, as shown in Figure 3, in parallel to the iCBT study. By 
integrating this process evaluation information with the outcome data, we will maximise our 
ability to interpret the results and the effectiveness of the intervention.49  
 
We will be combining components from three evaluation models, namely the Reach, Efficacy, 
Adoption, Implementation and Maintenance (RE-AIM model);50,51 and those of Linnan and 
Steckler,52 as well as those of Baranowski and Stables.53 The following eight components have 
been selected:  
1. Recruitment: procedures used to approach and attract participants. 
2. Reach: the extent to which the targeted population were drawn to the study and were 
willing to be involved in this intervention study. 

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3. Context: characteristics of the participants that affect the iCBT intervention including 
social, demographical, socio-economic factors. 
4. Dose delivered: The number of modules and component included in this iCBT 
intervention. 
5. Dose received: The extent to which participants actively engage and interact with the 
resources provided by this iCBT intervention. 
6. Effectiveness: examining both the positive and negative consequences of the 
intervention, as well as factors that may positively or negatively influence the 
effectiveness of the intervention from the participant’s perspective. 
7. Maintenance: keeping participants involved in this iCBT intervention and data 
collection. 
8. Fidelity: The extent to which the intervention was implemented as planned. 
 
These processes will be monitored during the intervention, by reflecting on study procedures 
and participant’s experiences. After undergoing the intervention, participant satisfaction will 
be established using a Likert scale and telephone interview.  
 
 
 
Pilot study 
All materials will be piloted prior to running the study. Both professionals and those with 
tinnitus will test all aspects of the platform. Likert scaled questionnaire will be administered, 
asking specific questions related to the suitability, usability, content and experiences with the 
intervention and questionnaires, together with open-ended questions. The aim will be to 
identify any hindrances regarding use of the platform and possible barriers to participation. If 
any major changes are required, the ethical committee and trial body will be notified. 
 
Further feasibility measures will include the recruitment rates, retention of participants, 
compliance and acceptability of the intervention by participants.  The feasibility of having an 
Audiological professional running the intervention under supervision, instead of a Psychologist 
will also be evaluated.  
 
Data collection 

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All data will be collected online. Baseline data will be collected at pre-treatment (-T1), prior to 
allocation. During the active phase of the intervention, the 10 questions on the THI-S25 will be 
collected on a weekly basis. Data will then be collected at post-treatment (T1) and after the 
control group completes the intervention (T2).  To determine long-term effectiveness of the 
intervention, data will again be collected 12 months (Tx) after the start of the intervention at 
close out, and this will end the study. The specific outcome measures for each collection point 
are shown in Table 3. 
 
To improve attrition rates at follow-up, an e-mail will be sent to encourage participants to 
complete the questionnaires, with a maximum of three reminders. If they do not wish to further 
participate in the study, the reasons for their withdrawal will be recorded, where provided, by 
means of a post-treatment satisfaction questionnaire. 
Table 3: Schedule of enrolment, interventions and assessment  
 
STUDY PERIOD 
 
Enrolment 
Allocation 
Post-allocation 
Close-out 
TIMEPOINT 
-T1 
T0 
T1 
(8 
weeks) 
T2 (16 
weeks) 
Tx (1 year) 
ENROLMENT 
Eligibility screen 
X 
 
 
 
 
Informed consent  
X 
 
 
 
 
Allocation 
 
X 
 
 
 
INTERVENTIONS 
Experimental group 
 
 
 
 
 
Control group 
 
 
 
 
 
ASSESSMENTS 
 
Tinnitus Functional Index 
X 
 
X 
X 
X 
Tinnitus 
Handicap 
Inventory-
Screening Version 
X 
X 
(weekly) 
X  
X  
X 
Hearing 
Handicap 
Inventory- 
Screening Version 
X 
 
X 
X 
X 
Insomnia Severity Index 
X 
 
X 
X 
X 
Cognitive Failures Questionnaire 
X 
 
X 
X 
X 
Hyperacusis Questionnaire 
X 
 
X 
X 
X 
 

15 
 
Patient Health Questionnaire 
X 
 
X 
X 
X 
Generalised Anxiety Disorder 
X 
 
X 
X 
X 
Satisfaction with Life 
X 
 
X 
X 
X 
 
 
Data Management 
All participants will receive a non-traceable unique reference code to keep their identities 
blinded during the result analysis. All files used will be password protected. The researchers, 
statisticians and internal data monitoring committee (DMC), will have access to the final 
dataset. The DMC includes researchers who are independent to this study without competing 
interests. They will ensure accurate analysis and result interpretation. 
 
 
Data Analysis 
Data analysis will be in accordance with Consolidated Standards of Reporting Trials 
(CONSORT) guidelines for randomized clinical trials.54 The Statistical Package for Social 
Sciences (SPSS) version 20.0 will be used and the data analyst will be blinded to the groups, 
to minimise bias. Results at post-treatment will be based on an intention-to-treat paradigm, in 
which incomplete data sets will be analysed using multiple imputation, offered by SPSS. For 
all analyses, a two-tailed significance level of < 0.05 will be considered statistically significant. 
The data will be analysed, using a general linear model repeated measures approach to look at 
the effects of the intervention and changes over time.  
 
Qualitative content analysis with a positivist philosophical approach will be used to analyse 
the responses for open-ended questions.55 Integrating different analysis methods will yield 
further insight into the study outcomes.56  
 
The study results will be shared in peer reviewed publications by the present authors and 
presented at research conferences. A summary of the findings will be available to study 
participants, members of tinnitus support and tinnitus charity groups. 
  
Ethical considerations 
Ethical approval has been granted by the Research Ethics Committee (REC) of Anglia Ruskin 
University (FST/FREP/14/478).  Participation is voluntary and all participants will provide 

16 
 
informed consent online. A full explanation of every step of the study and will given and 
participants will be able to withdraw at any stage without penalty. 
 
A protocol has been established to ensure the security of participant’s confidentiality on the 
web-portal, complying with European guidelines for internet studies. Participant’s data will be 
anonymised as unique reference codes will be used. Protocols to minimise the risks to 
participants and the researcher have been put in place. The data, together with any other 
spontaneously reported adverse events during the intervention will be reported. If any 
participants were identified as requiring additional support, a letter will be provided for them 
to take to their General Practitioner, so that this care can be arranged.  
 
DISCUSSION 
 
In this paper, the design of a study, to investigate the effectiveness and feasibility of an internet-
based intervention for tinnitus in the UK, is outlined. The strength of the proposed methodology 
is the randomised design. A further strength is that not only the effects of the iCBT intervention, 
but also the process evaluation will be investigated, to fully determine the interventions 
feasibility and effectiveness. 
 
This particular tinnitus intervention has been selected due to the numerous potential benefits it 
may have. It is a standardised treatment, in which each participant has access to the same 
materials. The researchers have however carefully considered how to improve on methods used 
in similar previous studies and built on these. The following improvements will be made during 
this study. Firstly, redesigning the module content and combining both CBT and audiology 
principles, thereby ensuring it is multidisciplinary in nature. Secondly, transforming the 
presentation of materials into an interactive e-learning version, which is visually stimulating 
may improve participant engagement. Thirdly, using a main outcome measure that is 
specifically designed for measuring intervention effects. Fourthly, assessing a range of 
outcomes to help identify for whom this intervention is most suited. Fifthly, enabling the 
intervention to be presented by an Audiologist instead of a Psychologist. Lastly, aiming for 
good participant retention by careful inclusion criteria and screening methods. 
 
There are however potential barriers that can be forecasted for this study. Although according 
to the 2015 report from the Office of Statistics,57 86% of the population in Great Britain have 

17 
 
internet access, there is still a proportion who don’t have access and will therefore not be able 
to partake in this study. Those without access may be older adults, which might impact the 
sample selected.  There are also people with visual or motor disabilities who will be unable to 
use a computer effectively, and therefore may not be suitable for this intervention unless they 
have assistance.  A further barrier is that participants will require motivation to complete the 
questionnaires and treatment modules. A limitation of the study design is that it is not possible 
to blind the researcher and participants during the intervention, as they will know in which 
group they have been placed. Bias will however be minimized by stratification and blinding 
during randomisation, and data analysis.  
 
Feasibility and uptake of such an intervention will be determined by this study. It is however 
encouraging that other internet based studies, run within the UK, for other health related 
concerns,58,59 have reported sufficient interest.  Due to the multidisciplinary nature of the study, 
it furthermore has the prospect of determining the effects of the iCBT intervention not only on 
tinnitus outcomes, but also on the person globally, as various comorbid factors are being 
investigated.  
The potential impact of this research is that it can change the way in which tinnitus services 
are delivered in the UK.  If effective, iCBT may be suggested for certain tinnitus sufferers 
following their clinical examination. This will address differential clinical demands and reduce 
the number of tinnitus suffers needing face-to-face consultations. This may in turn diminish 
the current burden on the NHS healthcare and lead to a significant potential cost saving to the 
health service. It may also make treatment available to many who are unable to access speciality 
tinnitus services  
 
If this intervention is feasible, future studies should focus on comparing iCBT to the usual 
tinnitus care in the UK. It is expected that the results of this study will become available early 
in 2017. 
 
 
Figure legends 
 
Figure 1: Flow chart of the study design 
Figure 2: The modified iCBT intervention 
Figure 3: The processes to be evaluated following the study 
 

18 
 
Abbreviations 
CBT- Cognitive Behavioural Therapy 
CFQ- Cognitive Failures Questionnaire 
CONSORT- CONsolidated  Standards of Reporting Trials  
CSQ-8 - Client satisfaction questionnaire 
DMC- data monitoring committee 
DOH- Department of Health 
GAD-7- Generalized anxiety Disorder 
HFDTT- High Frequency Digit Triplet Test  
HHIA-S – Hearing Handicap Inventory for Adults- Screening Version 
HQ- Hyperacusis Questionnaire 
iCBT- Internet based Cognitive Behavioural Therapy Intervention 
ICF- International Classification of Functioning 
ISI- Insomnia Severity Index 
NHS- National Health System  
PHQ-9 Patient Health Questionnaire 
REC-Research Ethics Committee 
RCT-Randomized Control Trial 
SPIRIT-Standard Protocol Items, Recommendations for Interventional Trials 
SPSS - Statistical Package for Social Sciences 
SWLS- Satisfaction with Life Scales 
TFI- Tinnitus Functional Index 
THI-S- Tinnitus Handicap Inventory-Screening Version 
UK – United Kingdom 
WCI- weekly check-in control group 
 
 
Funding 
This research received no specific grant from any funding agency in the public, commercial or 
not-for-profit sectors. 
 
 
 
 
 
 
 
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daily life activities: a psychometric examination of the Tinnitus Disability Index. Ear Hear 
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