Introduction

Thank you for your interest in taking part in this study into the usefulness of mindfulness in the self-management of multiple sclerosis in adults.  As this is an academic study, there is a lot of information for you to read and then you will be asked to tick some boxes to give your consent. This should take approximately 10 minutes so please don't be put off and keep going until the end!

At the end of this information sheet, you will be given a link to the baseline questionnaire which you must take before you can begin the mindfulness sessions.
Invitation
You have been invited to take part in a research study by an MA student at De Montfort University.  Before you decide whether to take part, it is important for you to understand why the research is being done and what it will involve.  Please take time to read the following information carefully and discuss it with friends or relatives if you wish to.   Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether you wish to take part or not. Thank you for reading this.

What is the study about?
The study aims to find out whether a short and cost-free course of mindfulness sessions could be effective in helping you to manage your MS. Previous studies done by other researchers suggest that potential benefits may include an improvement in levels of fatigue, depression, anxiety or other symptoms, particularly those that are worsened by stress.

What does the study involve?
This study is open to anyone with a confirmed diagnosis of multiple sclerosis who is aged 18 or over and who has access to an internet-enabled smartphone or tablet. It will involve downloading and using the Headspace app for up to 10 minutes a day for 10 days within a 14 day period.

Participants in the study will first be asked to complete an online questionnaire. A link will be found at the end of this information sheet and will also be sent in an email.  This survey will include some basic questions about your MS, such as the year of diagnosis, your present type of MS and the symptoms you experience. It will also include an assessment of your current levels of depression, anxiety and fatigue because these are the areas that are most likely to show improvement. Asking these questions at the beginning will enable us to measure whether there is any improvement by the end. The responses will be confidential and stored in a secure location. They will only be seen by the researcher and possibly her supervisor, if requested.

After completing the survey, you will be asked to download the Headspace app onto a smartphone or tablet and complete 10 free 10-minute mindfulness sessions. You will be asked to do things like focus on your breathing and you will learn some basic meditation techniques which may be useful to you in your everyday life. You can find out more at https://www.headspace.com/how-it-works.

Finally, you will be asked to repeat the questionnaire to see if you have noticed any changes.

10 randomly-selected participants will then be asked to take part in a 30-minute online interview.

A record of your email address will be used to contact you for the follow-up survey, but you will choose a username so that your questionnaire answers can be kept completely separate and you cannot be identified in any way during the research.

Why have I been chosen?
The invitation to take part has been extended to anyone over the age of 18 with a confirmed diagnosis of MS. The aim is to find at least 20 people who are willing to take part. Everyone who responded to the advert has been sent an invitation to participate. Anyone who has MS is eligible to take part.
Do I have to take part?
It is up to you to decide whether to take part.  If you do decide to participate, you will be able to keep this information sheet. You will be asked to check a box on the online survey to indicate that you give consent for your data to be used anonymously. If you decide to take part you are still free to withdraw at any time and without giving a reason.

I am interested in taking part, what do I do next?

If you agree to the questions at the end of this survey, you will find a link to the initial questionnaire. Within 24 hours, you will also be emailed this link, so you can take a break first if you wish. You will also receive a copy of this information sheet, some instructions which will tell you how to download the app and start the sessions and a sheet with some useful contact details. If there are any problems, you can email Helen Croxon using this email address: P2508772@my365.dmu.ac.uk.

What if I agree to take part and then change my mind?
If you start completing the survey and then change your mind, you do not need to complete it. There is no obligation to take part.

If you complete the initial survey and start the Headspace sessions but decide not to continue, you may withdraw without giving a reason. However, it would be helpful if you would be willing to complete a short follow-up survey to say why you didn’t want to continue because this is a useful part of the research. One of the aims is to find out whether it is easy for people to access the sessions and whether they feel motivated to continue until the end.

If you would like to withdraw any data you have already given when you decide to stop participating, you can request this at the time of withdrawal by emailing Helen Croxon using this email address: P2508772@my365.dmu.ac.uk. After the date of your withdrawal, it is not possible to request the destruction of data as it may have already been used anonymously as part of the analysis.

What is the procedure that is being tested?
The study will test the ease of downloading and using the Headspace app to see whether this is suitable for most people to do at home on their own.

What are the possible disadvantages and risks of taking part?
Headspace has over 31 million users and is considered to be harmless, whether you personally find it useful or not. You do not need to give your bank details or sign up to a free trial in order to take part as these sessions (the 'Basics' course) are free. If you feel that you have additional concerns during the study (for example about your MS symptoms or levels of depression, anxiety or fatigue) you can consult your GP or MS nurse in the usual way. You will also be given the contact details of some websites and helplines which you may find useful. However, you should consider carefully whether you would find it difficult to complete online surveys and use a smartphone app due to MS symptoms or mental health difficulties.

The researcher will use the SurveyMonkey website to collect survey data, which means that your data will be stored on a third-party website. You will also have to provide your name, email address and a password to create a Headspace account. Both of these organisations use cookies, although you may disable these if you wish. Whilst every effort has been made to ensure that these are reputable and reliable companies, as with all large companies that store and process our data, there is a risk of a data breach. Responsibility for storing and processing your data lies directly with Headspace and SurveyMonkey. When you come to use their products, you will be asked to give consent directly to them. You should consider whether you are comfortable with your data being stored and processed in this way.
What are the possible benefits of taking part?
Hopefully, you will feel a benefit from taking part in the mindfulness sessions, although this is not guaranteed. You may find that you learn some techniques that will help you to manage your condition in the long term. Your answers will contribute to research that may be able to help other people with MS by showing them whether doing free mindfulness sessions at home will help them to manage their condition.

What if something goes wrong?

If you are harmed by taking part in this research project, there are no special compensation arrangements.  If you are harmed due to someone’s negligence, then you may have grounds for a legal action but you may have to pay for it.  Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal University complaints mechanisms should be available to you.

Who can I complain to?
If you have a complaint regarding anything to do with this study, you can initially approach the lead investigator (Helen Croxon).  If this achieves no satisfactory outcome, you should then contact her supervisor, rachel.rouncefield@dmu.ac.uk or the Administrator for the Faculty Research Ethics Committee, Research & Commercial Office, Faculty of Health & Life Sciences, 1.25 Edith Murphy House, De Montfort University, The Gateway, Leicester, LE1 9BH or hlsfro@dmu.ac.uk

Will my taking part in this study be kept confidential?
All information which is collected about you during the course of the research will be kept on a password protected database and is strictly confidential. You will choose a username (ID code) which will be used instead of your name. Any identifiable information you may give will be removed and anonymised.

The data will be kept for 5 years after a study has been completed. The researcher’s supervisor will also have access to the data and that members of the faculty human research ethics committee may require access to check that the study has been conducted in accordance with the approval.  Although this is not the topic of the study, you should also be aware that I may be duty bound to pass on information that you provide that reveals harm has occurred to a child or other vulnerable individual.

What will happen to the results of the research study?
The results of this study will be written up as a dissertation which will form the final part of the researcher’s Masters degree. A copy will be available on request.

Who is organising and funding the research?
The research is not sponsored or funded by any company or organisation, including any organisation that has advertised this research project or shared the advert on social media. This is a personal study for an MA degree programme at De Montfort University.

Who has reviewed the study?
This study has been reviewed and approved by De Montfort University, Faculty of Health and Life Sciences Research Ethics Committee.

Contact for Further Information
If you would like further information about the study or the results, please email the lead investigator using P2508772@my365.dmu.ac.uk

Thank you for volunteering to taking part in the study.

Question Title

* 1. Please provide an email address so that you can receive further information and instructions about the study.

Question Title

* 2. Confirm your email address. Please ensure that this is correct.

Question Title

* 3. I confirm that I have read and understood the information for this study.  I have had the opportunity to consider the information and ask questions and have had these answered satisfactorily.

Question Title

* 4. I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason.

Question Title

* 5. I understand that Survey Monkey will be used to collect, anonymize and process my responses on behalf of the researcher. I understand that Survey Monkey is responsible for storing and securing my data in accordance with the Survey Monkey security statement https://www.surveymonkey.co.uk/mp/legal/security/ and privacy policy https://www.surveymonkey.co.uk/mp/legal/privacy-policy/. I give permission for my data to be stored and processed in this way.

Question Title

* 6. I understand that I will need to download the Headspace app, which will ask me for my name and email address and a password that I will create. I also understand that Headspace is responsible for the collection and storage of this data and it will be protected by Headspace according to GDPR regulations, as detailed in their privacy policy. https://www.headspace.com/privacy-policy

Question Title

* 7. I understand that the Headspace app will use cookies for app-related usage and that I may disable them as described in the Headspace Cookie Policy https://www.headspace.com/cookie-policy.

Question Title

* 8. I understand that data collected during the study may be looked at by a supervisor from De Montfort University. I give permission for the supervisor to have access to my data.

Question Title

* 9. I agree to take part in this study

Question Title

* 10. Please create a username. This will be used to identify you so that your details can be kept entirely confidential.

Your username should be the first two letters of your first name, the first two letters of your surname and your month and year of birth.

e.g. John Smith born in January 1980 would enter JoSm0180

Enter your username here

Please make a note of your username as you will need this for the initial questionnaire and the followup questionnaire.                  

T