Would you like to do an interview for our research study?
We are looking for volunteers to take part in interviews to talk about their opinions on use of personalised (N-of-1) trials in the mental health space
We want to talk to:
- Healthcare workers who care for patients with chronic mental health conditions requiring treatment
- Developers of non-pharmaceutical interventions for mental health (e.g. apps)
- Ethics committee members
You can find all of the information about the study in the participant information sheet or you can read the participant information below.
If you would like to take part please contact us on: tim.morris@ucl.ac.uk
Invitation to be interviewed for a study to understand attitudes and perceptions around personalised (N-of-1) trials for mental health conditions
- You can choose whether or not to be interviewed for this study. Before you decide, we would like you to understand why the research is being done and what it would involve.
- Please take time to read the following information carefully and decide if you want to take part.
- We are inviting you because you are involved in treating people with mental health problems, or are part of an ethics committee, or are a mental health treatment/app developer.
- We want to find out more about your experience and views on the use of personalised (N-of-1) designs in this context.
- Do ask if anything is unclear.
- Thank you for reading this information and for considering taking part in the interview study.
Summary
- We are doing a study looking at the views and experiences of people around using personalised (N-of-1) designs in the area of mental health.
- You do not have to have had experience of using personalised (N-of-1) designs to take part in this study.
- This research will help us understand barriers and facilitators to the uptake of personalised (N-of-1) designs for evaluating mental health interventions in the UK.
- The study involves being interviewed for 30–60 minutes by a researcher about your experiences and views.
- The interviews will take place at a time that is convenient for you and the researcher, over Microsoft Teams.
Why are we doing this study?
This study is trying to find out more about the potential to use personalised (N-of-1) designs to evaluate interventions for mental health problems in the UK. As part of this, we want to find out more about the experiences and views of healthcare workers who deal with mental health patients. We also want to talk to Ethics Committee members, and people involved in developing apps and treatments aimed at improving mental health. This will help us understand more about the practical challenges, barriers and facilitators to using personalised (N-of-1) designs in this context. We hope to be able to use what we learn to develop methodology to address these barriers.
What would taking part involve?
This study is an interview study. The interview will be a one-to-one discussion between you and a researcher. The interview will take approximately 30 to 60 minutes. The researcher will ask you questions about your views and experiences.
If you agree to take part, we will ask you a few simple questions about yourself in a short online questionnaire that will appear after you have completed the informed consent form.
If you agree to take part, the researcher will contact you to arrange a suitable time and date for the interview to take place. The interview will be conducted remotely over Microsoft Teams.
Before the interview starts, the researcher will go through this information and the consent form, to make sure you understand it all and are still happy to take part. You will be able to ask any questions you have about the interview study.
The interview will be audio-visually recorded using Microsoft Teams. After the interview, the recording will be transcribed so there is a written record of the interview. The transcription will be based upon the automatic transcription provided by Microsoft Teams but edited by the researcher to correct transcription mistakes.
The study’s researchers will listen to and analyse the interview, alongside the other interviews that take place. Only a few researchers, who need to see the data, will have access to the recording and transcript of your interview.
We will not use any names or affiliations in the written report, to ensure your confidentiality. We may use quotations from what you said to illustrate particular points, but individuals will not be identified against the quotations.
Who can take part?
We have invited you to take part in this discussion as you are either:
- A health professional who is involved in treating people with mental health problems,
- A member of an ethics committee, or
- A developer of non-pharmaceutical interventions (e.g. apps) for mental health
We want to understand your perspectives on using N-of-1 designs for mental health interventions.
You do not need to have experience of using N-of-1 designs to take part in this study.
Do I have to take part?
It is entirely your choice whether or not you take part in the interview.
If you agree to take part, then change your mind before the interview, please let the researcher know. If you change your mind about it during the interview, you can end the interview at any time, without having to give a reason.
What are the possible advantages of taking part?
Whilst there are no immediate benefits for those people participating in the project, it is hoped that this work will help us improve personalised (N-of-1) designs and make them easier to use for mental health interventions.
What are the possible disadvantages of taking part?
The potential disadvantage of taking part is that doing so requires 30–60 minutes of your time for the interview.
Will I be paid to take part?
There is no payment for taking part in the interview.
More information about taking part
Will my taking part in the interview be confidential?
We will keep any direct identifiers (such as your name and contact details, which we need to arrange the interview) separate from the interview data we collect from you.
When we share the findings with others, it will be an overview of the results for all the interviews as a whole, with no identifying information to allow others to identify you as an individual, or which institution you work at. Any summaries we produce of the discussion will be anonymous, and individual people will not be identified.
The interview will take place online. The recording of the interview and the transcript of the recording will be kept securely on encrypted computers, so only researchers involved in this aspect of the study can access it.
The information you provide in the discussion will be separated from your personal details and stored securely at UCL. The data custodian is Tim P. Morris. As participation is anonymous it will not be possible for us to withdraw your data once the interview is over and your data has been transcribed and anonymised. We will keep your data for a minimum of 10 years.
University College London is the sponsor for this study and will act as the data controller. This means that they are responsible for ensuring that your information is used and stored properly by researchers from the study team.
The lawful basis that would be used to process your personal data will be performance of a task in the public interest.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information at https://www.ucl.ac.uk/legal-services/privacy/ucl-general-privacy-notice-participants-and-researchers-health-and-care-research-studies
If you are concerned about how your personal data is being processed, or if you would like to contact us about your rights, please contact UCL in the first instance at:
Please note that assurances on confidentiality will be strictly adhered to unless evidence of wrongdoing or potential harm is uncovered. In such cases the University may be obliged to contact relevant statutory bodies/agencies.
How your data will be used in future and other research
The anonymised information we collect about you may be useful in future research. Other researchers, including some who may be working outside the UK, may ask to use your information. If they do, this will be considered very carefully by the researchers, the MRC CTU at UCL and independent scientists. We will not share any data that would allow others to identify who you are. We will follow all legal requirements to make sure that all information about you is treated appropriately and ethically, and that other researchers do so too. Your information will only be used by organisations and researchers to conduct research in accordance with relevant legislation, ethics and NHS research policy requirements.
The information will be held securely with strict arrangements about who can access the information. The information will only be used for the purpose of health and care research.
What if something goes wrong?
If you have a concern about any aspect of this study, please contact the lead researcher, who will do his best to answer your questions. His contact details are:
Tim P. Morris, MRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ.
Phone: 0207 670 4883
Email: tim.morris@ucl.ac.uk
If you feel your complaint has not been handled to your satisfaction, you can contact the Chair of the UCL Research Ethics Committee – ethics@ucl.ac.uk
(Ethics ID: 28633.001)
What will happen to the results of the study?
When the study is completed, we will email a summary of key findings, and links to any journal articles, to study participants who have asked to receive the results. We will publish a summary of the results on http://www.mrcctu.ucl.ac.uk/. We will publish the results in an academic journal.
Who is organising and funding the study?
This qualitative study is organised by researchers from the MRC Clinical Trials Unit at UCL. The study coordination, data collection and analysis, and administration will be provided by the MRC CTU at UCL. You can find out more about us at www.mrcctu.ucl.ac.uk/. The study is sponsored by University College London.
The study is funded by the MRC/NIHR Trials Methodology Research Partnership https://www.methodologyhubs.mrc.ac.uk/about/tmrp/.
UCL has overall responsibility for the conduct of the study. They are responsible for ensuring the study is carried out ethically and in the best interests of the study participants.
Who has reviewed the study?
This study has been reviewed and given favourable opinion by the UCL Research Ethics Committee.
Consent process
Thank you for taking the time to read this information sheet and considering this study. If you have any questions, please contact Tim P. Morris.
tim.morris@ucl.ac.uk 0207 670 4883
You can download a copy of this information.
If you agree to be interviewed, please complete the consent form and short questionnaire online. This questionnaire will help us pick a wide range of people to take part in our study. If you are chosen, a member of the research team will then contact you to arrange a suitable time for the interview.
Before the interview starts, they will go through this information with you, and check you are still willing to take part.
Go to the consent form
What is an N-of-1 trial?
Find more information about N-of-1 trials.
How to contact usFor more information, please contact Tim P Morris, tim.morris@ucl.ac.uk
MRC Clinical Trials Unit at UCL
Version 2, 22 October 2024 Ethics Committee reference number: 28633.001 |
