Before you decide whether to take part in this study, it is important to understand why we are conducting this research, and what is involved. This page will provide you with this information. Please read the following information carefully and take your time to decide. You may want to talk to others about the study before taking part. If you decide to take part, you can change your mind and withdraw at any time with no consequence.
Download participant information sheet
About us: We, ieso, are a company that provides mental health services to the NHS across England and Scotland. We are funding and running this study to test the use of computer/mobile-based digital tools to help people with mental health concerns.
Speak to us: If anything is not clear on this information sheet or you have questions about the study, please contact the research team at: email@example.com
Title of Project: Iterative design and usability testing of a digital tool for common mental health concerns
This study tests a digital tool (an app) that provides information about mental health. We know that mental health apps are being widely used, but evidence shows that many people do not find these engaging. We are testing our new app with members of the public to gain feedback about the design and experience of using it. This will help us improve the tool, so we can offer it to people concerned about their mental health. Importantly, this study is only designed to gain feedback about the usability and acceptability of the app. This study does not provide a course of medical treatment.
Who can take part in this study?
You can take part in this study, if:
What happens if I decide to take part in this study?
You will be able to sign up for the study via a study management website called 'userinterviews.com'. Here you will provide your contact details, fill out a screening questionnaire and we will ask you to sign a consent form. It is important that we obtain your written consent before you participate. A sample form is shown on the last page. After you sign the form, we will book an online session where you can test our app. The whole study is remote: you do not need to travel to take part.
If you have any questions about the study, please ask the research team before you sign the consent form. You can ask more questions during the testing session, and you can change your mind and withdraw your consent at any time.
What happens in the session?
You will have a written, text-based conversation with a computer or a person by typing into a chat window on a mobile phone app or a web browser (like a WhatsApp conversation).
Normally you will interact with a computer, but sometimes you may interact with a human following a pre-defined script. While you are interacting with the app, our researcher (who will be online with you throughout your session) will ask you some questions about what you are thinking, feeling, and doing as you use it.
We will use some software to record the computer or mobile phone screen while you use the app. Like recording a Zoom call or Teams meeting, this software captures only what you do during the session – it will not record other things from your computer or mobile phone. We will use these recordings to analyse how you interacted with the app.
When you finish using the app, we will ask you some questions and ask you to fill out questionnaires to get your feedback on the design and experience of using the app.
Something important for you to note:
The written exchange between you and the app will NOT be reviewed or monitored by a clinician. However, our researchers will be able to read the text as part of their research and development work. Do not share anything that you do not want another person to read. The written exchange will also be used to train machine learning models to help make conversations more engaging. These data will not be linked to any other data about you or contain any directly identifiable information. When researchers analyse the data, they will not know who wrote the text.
How long does it take?
The whole session should take around 90 minutes to complete. At the end of the session, we will send you another information sheet to debrief you and ask if you have any more questions about the study. Your involvement in the study will end after you have been debriefed or after you request to withdraw.
Will I be paid for taking part in this study?
We will give you a £40 amazon voucher to thank you for your contribution. We will send this to you once your participation in the study ends.
What are the benefits of taking part in this study?
Your participation will help us develop tools that help people with mental health concerns, such as anxiety or depression. Our mission is improve access to mental healthcare for as many people as possible.
What are the possible disadvantages and risks of taking part in this study?
We do not anticipate that taking part in this study will pose a significant risk to you. However, it is important to understand that the app will ask questions about your thoughts and feelings. You do not have to answer these based on your own personal experience, especially if that might cause you to feel distressed. If you start to become distressed, please alert the researcher who will be able to help.
ieso does not provide a crisis service. A clinician will not monitor or review your interaction with the app. This study does not provide a treatment for any mental health problems.
If you are struggling with your mental health, please use the below resources.
If you need urgent help, call 999
What data will be collected as part of this study?
How will we use information about you?
We take great care to protect your information to keep your data safe and secure. We comply with all UK data protection legislation and have provided you with our privacy notices. The only directly identifiable information we will obtain about you is your:
Only a small group of our employees running this study will have access to this information. Any other ieso researchers that use your data will only see a unique code that does not provide identifiable information. Your personal information is strictly confidential and will not be published, shared, or discussed with anyone. We will store video or audio recordings of you interacting with the digital tool securely in a password protected directory separate from any personal information.
We will store your data confidentially and securely within the Microsoft Azure cloud environment, in the UK. ieso follows nationally and internationally recognised standards for information security (Cyber Essentials Plus ISO 27001).
At the end of the study, we will delete any screen recordings or transcripts of interviews as soon as analysis is complete and within 1 year of collection at the latest. In line with current best-practice recommendations, we will hold all other research data for up to 20 years (outlined in our privacy notice).
What are my data protection rights?
We have assessed all of your information rights in relation to this research and have made some restrictions based on when these rights would no longer be possible.
If you wish to withdraw your data, you may do so until the point a data report is generated which may occur any time from participation to 2 weeks after participation. If you wish to withdraw your data speak to the researcher or please contact the Study Team: firstname.lastname@example.org
What will happen with the results of this study?
We will analyse the data and produce a report with our findings. These findings may be published in academic and scientific peer-reviewed journals. Your name or directly identifiable data will never be included in any publication. The feedback we collect as part of this study will help us improve the design of our app.
What happens if I don't want to carry on with the study?
Your participation in this study is voluntary. It is important to discuss any concerns you may have with a member of the study team before you agree to participate. However, you can withdraw from the study at any time and without giving a reason.
I have more questions... what should I do?
If you would like to ask any questions about the study or find out more information, please contact the Study Team: email@example.com.
Our researchers have a responsibility to protect participants and others from risks to physical and/or psychological distress. If any sensitive information is disclosed or witnessed during a research session and the researcher believes there is imminent danger to you or someone else, then confidentiality will be broken. In these extremely rare situations, the researcher will discuss all courses of action with you.
What if I have any concerns?
If you have any concerns about this study, you can contact ieso’s Research Governance Board at RGB@iesohealth.com, or by phone on 0800 074 5560.
If you wish to make a formal complaint, please submit to RGB@iesohealth.com
ieso, Jeffreys Building, St Johns Innovation Park, Cowley Road, Cambridge, CB4 1DS
If you are unhappy with the outcome of your complaint, you can contact the
Independent Sector Complaints Adjudication Service (ISCAS):
70 Fleet Street
Tel: 020 7536 6091; Email: firstname.lastname@example.org
Who has reviewed this study?
All ieso research studies are reviewed to protect your safety, rights, well-being, and dignity by our Research Governance Board and ieso Ethics Panel.
Does this study have any commercial benefit?
This study may have commercial benefit for ieso. Participants will not benefit financially in any way if commercialization of any research findings are successful.
If you would like to join this study, please proceed to userinterviews.com