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PARTICIPANT INFORMATION SHEET AND EXPRESSION OF INTEREST

Study Title: "Is Two better than One? Investigating the effectiveness of dual therapy for tinnitus management"

Introduction:

A warm welcome from the Hearing and Tinnitus Research Innovation Group at Flinders University in Adelaide, South Australia!

We would like to invite you to take part in a research study.
This research study is part of a project that investigates tinnitus management - particularly this project will investigate non-invasive brain stimulation as a new treatment for tinnitus and its dual impact with cognitive behavioural therapy.

You must be over 18 years old and have been experiencing constant tinnitus for at least 6 months to be eligible for this study.

Before you decide to take part, it is important for you to understand why the research is being done and what it will involve. Please take your time to read the participant information carefully. Please contact us if anything is unclear or if you need more information.

Take your time to decide if you would like to participate. Participation is voluntary.

Researchers:

Chief Investigator
Ms. Tharin Sayed
College of Education, Psychology and Social Work
Flinders University
Email: tinnitus.research@flinders.edu.au

Supervisor
Professor Raj Shekhawat
College of Education, Psychology and Social Work
Flinders University
Email: giriraj.shekhawat@flinders.edu.au

Associate Professor Kenneth Pope
College of Science and Engineering
Flinders University
Email: kenneth.pope@flinders.edu.au

Professor Vinaya Manchaiah
School of Medicine
University of Colorado
Email: vinaya.manchaiah@cuanschutz.edu

What is this research about?

Around 10-15% of people hear sounds such as ringing in their ears, which is called tinnitus. To some of these people, this is severely distressing. There is currently no cure for tinnitus.

We want to find out if a new research tool can offer relief to people who suffer from tinnitus. This research tool is called high-definition transcranial direct current stimulation (HD-tDCS). HD-tDCS is a non-invasive and safe technique which delivers a small amount of electrical current through the scalp and into the brain regions involved in tinnitus (i.e. brain stimulation).
We will be combining the effects of HD-tDCS with Cognitive Behavioural Therapy (CBT). CBT is the only gold-standard treatment method indicated for tinnitus, however access to CBT services is low - especially in South Australia. We will be using an online CBT application, iTerapi, that is a self-help program that was originally developed in Sweden. It has since been studied extensively for UK and US populations. Progress through iTerapi is self-paced, with weekly modules, videos and further guidance provided by an audiologist.

This research study is supported by the Royal National Institute for the Deaf (UK), the Rosetree foundation and Flinders University.

What benefit will I gain from being involved in this study?

You may enjoy taking part and contributing to tinnitus research and the brain stimulation may give you some relief from your tinnitus. You will also receive a free hearing test and tinnitus assessment. The sharing of your experiences will help us learn more about tinnitus so that we can work to improve tinnitus care and develop a long-term treatment.

Who can participate?

You can participate if you:

Are over the age of 18
Have been experiencing constant tinnitus for at least 6 months
Have access to and can use the internet and email effectively

You will not be able to participate in this study if you:

Have tinnitus that varies with your pulse
May be pregnant
Have a history of epilepsy or seizures
Have any implanted devices such as a hearing implant, pacemaker or defibrillator
Have any implanted metal in your head or neck (not including dental fillings)
Have ever had brain surgery
Have ever had a skull fracture
Are currently undergoing another tinnitus treatment
Are awaiting surgical intervention for hearing/tinnitus

How do I register my interest in participating?

If after reading this participant information sheet, you would like to express your interest in participating in our study, you will be directed to complete an "Expression of Interest" form.

This can be done online OR by completing the form at the end of this document and returning it via email.

What will I be asked to do?

Stage 1: Pre-Screening
If you qualify for our study based on the answers you provide in your 'Expression of Interest', a researcher will contact you via email and arrange a time that is convenient for you to take part in a short, voluntary phone call. During this phone call, we will discuss the answers you have provided in your form to ensure that you are eligible and that it is safe for you to participate in our research study.

Stage 2: Initial appointment
If it is safe for you to undergo HD-tDCS and CBT, you will be asked to initially attend a 1 hr appointment at the Flinders University Tonsley campus, where we will:

Discuss the study with you
Answer and questions you might have
Ask you to sign a consent form to show that you are willing to participate in the study
Ask you to fill out several questionnaires about your tinnitus and your general lifestyle
Perform hearing assessments and tinnitus measures

We will then assign you to a study group.
Brain stimulation: There is a 50% chance you will receive placebo brain stimulation. This is assigned at random.
CBT: Allocation to this group will depend on your availability - there is a significant time commitment of 8 weeks of online therapy with weekly check-ins.

Stage 3: Brain stimulation
You will be asked to come to Flinders University Tonsley campus for 6 consecutive sessions. This may be 2 sessions over 3 weeks or 3 sessions over 2 weeks. Each session will take 30 minutes.

During these appointments you will receive 20 minutes of brain stimulation. The technique we use is called high-definition transcranial direct current stimulation or HD-tDCS. This method is safe and painless. We will put a cap on your head, that has holes that can fit electrodes. We will put several small electrodes in the cap with gel for conduction. A little bit of gel will therefore get in your hair (hair washing facilities are available, if required). A very small current will then be applied to your brain via the scalp. This might itch or tingle.

You will be asked to rate your tinnitus loudness and annoyance, at the beginning and end of each stimulation session. We will also ask you to note any changes in your tinnitus since your last session.

The researcher will be unable to tell you if you have received the placebo stimulation until the very end of the study.

Stage 4: CBT

Not all participants will undergo CBT during the study. However, access to iTerapi can be provided to participants, at the conclusion of the study.

You will be asked to log-in to iTerapi online, using your unique login and password. From there you will be guided through weekly modules consisting of information, videos and exercises about tinnitus management. This will last 8 weeks and can be done at your own pace throughout the week. Any answers to exercises will be available to the researcher. At the end of each week, you will be asked to fill out two, short questionnaires. Additional guidance can be provided at any time, using the online 'Message' feature.

Stage 5: Follow-up appointments
You will be required to attend 2 follow-up appointments at Flinders University Tonsley campus - at the conclusion of your treatment/s and 2 months after the treatment.

Potential Risks:

Questionnaires, hearing tests and tinnitus assessments
We do not expect the questions or assessments in this study to cause any harm or discomfort to you. However, if you experience feelings of distress as a result of participation in this study, please let the research team know immediately and we will stop the session without penalty. You can also contact the following services for support:

Lifeline - 13 11 14, www.lifeline.org.au
Beyond Blue - 1300 22 4636, www.beyondblue.org.au

HD-tDCS
HD-tDCS is a safe and non-invasive method but may cause the skin under the electrode to go a bit red, feel itchy or tingle - this is not dangerous and usually fades quickly. There are no known long-term risks associated with HD-tDCS. You can stop the session at any time without giving a reason and without penalty. It is possible your tinnitus symptoms may worsen during treatment.

Withdrawal Rights:

You may, without any penalty, decline to take part in this research study. If you decide to take part and later change your mind, you may, without any penalty, withdraw at any time without providing an explanation. To withdraw, please contact the Chief Investigator or you may just refuse to answer any questions / close the internet browser and leave the online survey / not participate in exercises at any time without penalty. Any data collected up to the point of your withdrawal will be securely destroyed.

Confidentiality and Privacy:

Only researchers listed on this form have access to the individual information provided by you. Privacy and confidentiality will be assured at all times. The research outcomes may be presented at conferences, written up for publication or used for other research purposes as described in this information form. However, the privacy and confidentiality of individuals will be protected at all times. You will not be named, and your individual information will not be identifiable in any research products without your explicit consent.

No data, including identifiable, non-identifiable and de-identified datasets, will be shared or used in future research projects without your explicit consent.

Data Storage:

The information collected may be stored securely on a password protected computer and/or Flinders University server throughout the study. Any identifiable data will be de-identified for data storage purposes unless indicated otherwise. All data will be securely transferred to and stored at Flinders University for at least five years after publication of the results. Following the required data storage period, all data will be securely destroyed according to university protocols unless I agree otherwise.

The information collected from the CBT protocol used in this study, iTerapi, will be stored securely on servers located on the premises of Linköping University, Sweden and will be subject to General Data Protection Regulation (GDPR). Any sensitive information, including contact information, journals, conversations, and answers to assignments, will be stored encrypted in the database. All data communication between servers and users is encrypted and all message communication related to the treatment takes place inside the platform, after logging in securely. Data collected through the study will be downloaded from iTerapi and stored in a secure server at Flinders University which will only be accessible by authorised study personnel. All laptops/devices used in the proposed study, will be password-protected. All data will be retained for a minimum of five years after the end date of the study.

How will I receive feedback?

On project completion, a short summary of the outcomes will be provided to all participants via email or published on Flinders University's website.

Ethics Committee Approval:

The project has been approved by Flinders University's Human Research Ethics Committee (Project ID: 2857).

Queries and Concerns:

Queries or concerns regarding the research can be directed to the research team. If you have any complaints or reservations about the ethical conduct of this study, you may contact the Flinders University's Research Ethics & Compliance Office team via telephone 08 8201 2543 or email human.researchethics@flinders.edu.au.

Thank you for taking the time to read this information sheet which is yours to keep.

If you would like to register your interest in participating in this study, please:
- Complete the online "Expression of Interest"
OR
- Download and fill in the "Expression of Interest" form and upload/email the completed document to tinnitus.research@flinders.edu.au

Do you wish to participate in this study?

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Would you like to be contacted about other tinnitus related studies?

Please enter an email address so that we can contact you for future tinnitus studies

First Name

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Last Name

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Do you wish to complete the "Expression of Interest" form online?

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Please sign to indicate you have read and understood the consent statement below.

By returning a completed form, you agree to the following consent statement:

The information I have provided is true to the best of my knowledge.
I understand that the data I provide will be securely transferred to and stored at Flinders University for at least five years after publication of the results. Following the required data storage period, all data will be securely destroyed according to university protocols, unless I agree otherwise.
I understand that only the researchers on this project will have access to the information I have provided.
If I am eligible to participate, I agree to being contacted by a member of the Tinnitus Research Group via email to discuss my participation in this research study.

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Date of signed consent

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D-M-Y

You may download a copy of the "Participant Information Sheet" for your own records.

Please click submit to be taken to the "Expression of Interest" form.

Attachment:Participant Information Sheet.pdf

If you would prefer to complete the PDF form, please follow the instructions below.

Download the 'Participant Information Sheet' document.
Fill in the Expression of Interest' form on pages 7 - 11.
Upload the completed form by clicking 'Upload file' or email it to tinnitus.research@flinders.edu.au.

Attachment:Participant Information Sheet.pdf

Upload file

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