PARTICIPANT INFORMATION SHEET

Project Title: A pilot and feasibility trial of a mindfulness and self-compassion group for young people with IBD

Lead Researcher: Rebecca YeatesCo-researcher(s): Georgina Rowse, Fuschia Sirois, Alan Lobo and Alenka Brooks. Contact Details: r.yeates@sheffield.ac.uk/ 0114 2226647

We would like to invite you to take part in a research study being conducted at the University of Sheffield, in collaboration with Crohn’s and Colitis UK and Sheffield Teaching Hospital NHS Trust. Before you decide whether you would like to take part, it is important to understand why the research is being done and what it would involve for you. Please take time to read the following information carefully. You may wish to talk to others about the study, to help you decide whether taking part is for you.

If anything is not clear or if you would like more information, please contact us by email: r.yeates@sheffield.ac.uk

What is the purpose of the study?Young people have told us that living with Inflammatory Bowel Disease (IBD) in early adulthood can be demanding because they are managing all the usual complexities of young adulthood (e.g., exams, relationships and leaving home) whilst also coping with a chronic health condition that they may just be learning how to manage. We understand that sometimes this can leave young people with IBD feeling stressed, low and anxious.

We have been researching what may be able to help young people cope with these feelings. Our work so far has suggested that focusing attention in a particular way on what is happening in the present moment, rather than the past or future (a skill called mindfulness) and learning how to be kind to yourself rather than self-critical (a skill called self-compassion) may help young people change their relationships with their thoughts and feelings and improve their quality of life.

This research aims to evaluate whether attending a 16-week mindfulness and self-compassion group can improve the way young people feel when living with IBD.

Who are you looking for to take part?We are looking for young people aged between 16 and 25 years, who have a diagnosis of IBD and are able to attend a group in Sheffield. To be able to engage in the group fully, it is necessary to be able to engage in light physical exercise and have time to practice skills you have learnt at home. Unfortunately, young people who do not speak and write confidently in IRAS 269847 Information Sheet. Version 2.0 Date 11.11.19 Page 1 of 8Pilot and feasibility trial of a mindfulness and self-compassion intervention for young people with IBD

English are not able to participate at the current time. There may be other factors which may mean you can participate, but at a later date (for example, we ask that you do not start this group if you have a scheduled surgery in the next three months), but we can discuss this if you wish to take part. We are looking to recruit approximately 60 young people.

Do I have to take part?No, your participation is entirely voluntary, and you do not have to agree to take part. If you do decide to take part, you will be asked to sign a consent form on the next page. If you change your mind later, you are free to withdraw from the study at any time without giving a reason. If you choose to withdraw from the study, we will try to contact you to ask why but you do not have to respond. If you decide taking part in this study is not for you, it will not affect your medical care in the NHS in any way and your personal data will be deleted from our systems.

What will happen if I agree to take part?After signing the consent form, you will be asked to fill out some questionnaires which will ask you how you are feeling emotionally and physically with your IBD now. We will also send you a faecal (stool) calprotectin test in the post for you to complete and send to the laboratory. We ask you to complete online questionnaires and stool tests when you agree to take part and at certain points during and after the group, as it allows us to see whether you experience changes in the way you feel emotionally and physically during and after the group. We will ask you to fill out the online questionnaires a total of seven times, and to complete four stool tests, the last time being six months after you complete the group. You will receive your stool kits via post and once you have taken a sample, you will be asked to either post or give your sample to your GP or a local Sheffield Teaching Hospital laboratory for analysis. The samples will be destroyed by the lab once they have been analysed. We will always email you when it is time to complete the questionnaires or a stool test to remind you.

Soon after completing the first questionnaires on the next page, Rebecca, the Lead Researcher, will be in touch by email to organise a telephone appointment to give you more information about your group, like when and where it will be held. Depending on when the next available group is, you might be able to start your group quickly or need to wait a short while. Rebecca can also talk to you about any questions you may have about the group as a research study for example, how we will measure whether the group is effective. As the date of your first session gets closer, the group facilitator will get in touch by telephone to introduce themselves, ask you what you are hoping to get for from the group and what sorts of exercises you will do in the group and at home.

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The group will run over 20 weeks, with a 4-week break in the middle, meaning you will attend 16 sessions. The group will take place in Sheffield City Centre. You will be in a group with around 12 other young people who also have a diagnosis of IBD. The first part of the group is 8 weeks long and focuses on learning about mindfulness: learning to focus on what is

happening in your mind, body and around you. You will then have a break for four weeks and the second part of the group, also 8 weeks long, will focus on learning about self-compassion: how to be kind to yourself in difficult times.

During the course, some sessions will be randomly chosen to be video-recorded to ensure the course is being delivered according to the programme (MBSR and MBCL) manuals. Sessions will be recorded using a video-camera and the videos will be transferred to an encrypted computer.

After you have completed the group, we will get in touch again to see whether you would like to tell us what you thought of the group; such as, what parts you found helpful and not so helpful. Participating in a post-group interview is optional. If you choose to have a post-course interview, we can conduct this at your home address or in a university premise.

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Step 1

Complete questionnaires and stool test

Step 2

Speak with lead researcher by telephone

Step 3

Shortly before group due to start, speak with group facilitator by telephone

Step 4

8-week mindfulness group (complete online questionnaires before and after group, stool test just after)

Step 5

4 week break

Step 6

8-week self-compassion group (complete online questionnaires before and after group, stool test just after)

Step 7

Speak with lead researcher face-to-face about how you found the group (optional)

Step 8

3 months after completing group, complete online questionnaires

Step 9

6 months after completing group, complete online questionnaires and stool test for last time

What are the potential benefits of taking part?It is hoped that attending the group can benefit the way you feel emotionally and physically and provide you with ways of coping when you feel low, anxious or stressed. Research also tells us that people can find it beneficial to learn new skills in a group with other people in similar circumstances so they can share experiences. You might find this too.

What are the risks and disadvantages of taking part?Whilst we hope attending the group benefits you, we must acknowledge that part of testing whether a new intervention can help you, is accepting that there is a risk it might not help or make you feel worse. We have chosen a group which we know has helped other people with similar difficulties to minimise this risk.

One of the reasons we ask you to complete online questionnaires during the study is to see how you are feeling as you progress through the group. Some of the questions you will be asked may make you think about your feelings and experiences, which may make you feel upset. If this is the case, you may wish to speak to someone you trust about how you are feeling, like a family member, friend, or your General Practitioner (GP) so they can support you. We will let your General Practitioner (GP) know if you agree to take part in this study, so they can be ready to support you if needed.

If you tell us (either in your online questionnaires or in the group) that you are experiencing very frequent thoughts that may cause you or someone else harm, we will let your GP know within 2 working days of receiving the information as they may want to get in touch with you and offer you some support.

What is personal information and what personal information will you collect about me and why?Personal information is any information that can identify you, like your name or home address. We will ask you to tell us your full name, email address and telephone number to allow us to contact you about the study. We will also ask you for your home address so we can send you your stool test kits. Finally, we ask you for the name and address of your GP so we can let them know that you plan to participate and if you withdraw or complete the group, so they can be ready to support you if you need them to. To safeguard your rights, we only collect personal information that is necessary for the study.

Will my personal information be kept confidential?All personal information obtained during the study will be kept confidential to the research team and will only be used for the purposes of contacting you about the research study. However, authorised representatives from the University of Sheffield might perform an audit of the study and review the study data to check the accuracy of the study.

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The only time we may need to share personal information about you with another organisation is if you share information with us that may suggest you, or somebody else, is at risk of harm. In one questionnaire we use, it asks you whether you find life meaningless. If you tell us that you feel this way very frequently, we will let your GP know within 2 working days as they may wish to contact you and offer support to you.

What is data and what data will you collect about me and why?When you fill out the online questionnaires about how you are feeling, your responses will be converted into a series of numbers, which is sometimes called data. We will use this data to evaluate whether the intervention has been helpful to you and others.

We will also ask you some questions about yourself, such as when you were first diagnosed with IBD, to understand if this information impacts how helpful the group is for you.

If you choose to talk to the Lead Researcher after the group about what was helpful and not so helpful, we will record our conversation and convert the audio recording into written text so we can analyse whether there are any similarities or differences in your experience, compared to other young people who completed the group. When we publish the results of the study, we may use some quotes from our discussion to demonstrate our findings. We will remove any data that identifies you from these quotes.

The University of Sheffield will use your name and contact details to contact you about the research study and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. The only people in The University of Sheffield with access to information that identifies you will be people who need to contact you for the study or audit the data collection process.

What will happen to my personal information and data?Your personal information and data will be stored in encrypted databases on the Lead Researcher’s secure password protected university computer with anti-virus software. Once your involvement in the study ends, all your personal information will be removed from our database which will make your data entirely anonymous. When the study has ended, the database will be archived for 5 years. The anonymised research data will be uploaded onto a secure open data network to show our results are based on real data. You will not be identifiable in this database. If you opt for your personal information to be retained so we can contact you about future IBD studies being conducted at the University of Sheffield, this will be stored in a separate password protected database on an encrypted University laptop so future researchers can access your information only when required. This database will be retained for 5 years.

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This project is being organised and sponsored by The University of Sheffield. The University of Sheffield is the data controller for this study, this means that we are responsible for looking after your information and using it properly. The research team at The University of Sheffield are responsible for storing your anonymised data. The people who analyse your data will not be able to identify you and will not be able to find out your name or contact details. The anonymised data will be kept indefinitely to provide evidence that our results are based on real data, should this be required.

Your rights to access, change or move your data are limited, as we need to manage the data in specific ways for the research to be reliable and accurate. If you choose to withdraw from the study, we will keep your anonymised data that we have already obtained, but your personal information will be removed immediately. To safeguard your rights, we will use the minimum personally-identifiable information possible.

The information will only be used for the purpose of research and cannot be used to contact you or affect your care. It will not be used to make decisions about future services available to you, such as insurance.

What is the legal basis for processing my personal data?We are required to inform you that the legal basis we are applying in order to process your personal data is that ‘processing is necessary for the performance of a task carried out in the public interest’ (Article 6(1)(e)). Further information can be found in the University’s Privacy Notice https://www.sheffield.ac.uk/govern/ data-protection/privacy/general. As we will be collecting some data that is defined in the legislation as more sensitive (i.e. information about your medical condition), we also need to let you know that we are applying the following condition in law: that the use of your data is ‘necessary for scientific or historical research purposes.

Will you share any of my data with my IBD team?If you were referred to the study by your IBD team, they will know if you choose to participate in the study. However, no details about your participation will be shared with your IBD team. Everything you share with us in the group, questionnaires, post-course interview and in any telephone or email correspondence is confidential. The only exception being if we feel concerned you may be at risk and then your GP will be informed. If you were not referred to the study by your IBD team, they will not be aware of your participation. If you do not choose to participate, your care in the NHS will not be affected at all.

What will happen to the results of the project?

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After this research project has ended in 2021, the final results will be published on the Crohn’s and Colitis UK website. We will also report the findings in academic health journals and

present them to health professionals at meetings and conferences. You will not be identifiable in any reports or publications arising from the study.

If this study shows that the group can improve the mood and quality of life of participants, we intend to apply for funding to deliver the group to more people in different parts of the country to make it available for more young people who could benefit from it.

Who is organising and funding this project?  This project is being organised and sponsored by The University of Sheffield. The study is funded by Crohn’s and Colitis UK. Crohn’s and Colitis UK and Sheffield Teaching Hospital NHS Trust are supporting the study by sharing the research opportunity with eligible young people.

Who has reviewed this research?All research that takes place in the UK is reviewed by an independent group called the National Research Ethics Committee, to protect your interests. This study has been reviewed and given Favourable Opinion by the Tyne and Wear South Research Ethics Committee.

What if I am unhappy or if there is a problem?If you feel unhappy with any aspect of the study, you can contact the Lead Researcher by email or telephone to discuss this and your involvement in the study can be stopped. The Lead Researcher may want to ask you some questions so we can understand what went wrong, but you do not need to provide a reason for ending your involvement in the study if you do not want to. Withdrawing from the study will not affect your medical care in the NHS in any way.

What if I wish to make a complaint?Any complaints you have about this study will be fully investigated. If you have a concern about any aspect of this study, you can speak with the Lead Researcher Dr Rebecca Yeates at the University of Sheffield by telephone or by email. You could also discuss your complaint with the study Principal Investigator, Georgina Rowse on g.rowse@sheffield.ac.uk or the Head of the Psychology Department at the University of Sheffield, Professor Glenn Waller

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on g.waller@sheffield.ac.uk. In your email, please refer to the study title and Lead Researcher (detailed at the top of this form) in your subject heading.

What if I want to ask questions not included in this information sheet?Please raise any further questions you may have with the Lead Researcher; they will be happy to answer any additional questions you may have.

Thank you for taking the time to read this information sheet and considering taking part in this study.

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