Bounce Back Participant Information Summary

TITLE: Building Resilience in University Students

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What is this study about? 

This project seeks to find out if a written intervention informed by strength-based Cognitive Behavioural Therapy (CBT) enhances the ability of students to overcome and learn from life challenges, and if it is acceptable. The Bounce Back written intervention has been co-developed with students at the University of Exeter. Enhancing the ability of university students to ‘bounce back’ from adversity could potentially prevent any distress currently being experienced developing into anxiety or depression that needs psychological treatment. If it is helpful, the Bounce Back intervention could easily be made widely available to a large number of students at the University of Exeter and beyond.  

What will I have to do? 

You will be given the Bounce Back intervention for use on your own over a period of 6 weeks. During this time you will be contacted by email by a qualified Psychological Wellbeing Practitioner that has been trained in supporting the intervention. The offer of support by e-mail, teleconference or face-to-face if you are experiencing difficulties using the intervention will be provided. But there is no obligation to ask for any support unless you choose to.  

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Dependent on whether you are chosen by chance to start using the intervention immediately or after a 12 – 14 week delay, we will ask you to complete questions about personal resiliency, symptoms of anxiety and depression and wellbeing . These questions will be asked at the start of the study and at follow up timepoints of 6 weeks and 12 weeks. These measures should take no more than 10 minutes to complete at the start and end of the study. These measures will help us to understand if Bounce Back has potential to be successful in enhancing resiliency and if it prevents lower levels of distress from developing into levels of depression and anxiety for which treatment may be sought. We will also be looking at how successfully the study has been run. At the end of the study you will be given the opportunity to take part in a small focus group to explore how acceptable the intervention was and identify any areas of improvement.   

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What payment will I receive?
As a thank you and reward for completing each follow-up assessment, you will be sent electronic shopping vouchers worth £10.00 by email for completing the follow-up measures at 6 and 12 weeks  (i.e., up to a maximum of £20).
 

Why take part and what are the possible advantages of taking part? 

By taking part, you will play a major role in improving well-being and mental health for university students. Taking part may help you learn about, understand, and enhance your resiliency. It will also help us to improve well-being and mental health for other young people.  

Who can take part? 

University students (undergraduate or postgraduate above the age of 16) studying at the University of Exeter. We will ask you to complete online questionnaires to see if the study is likely to be right for you. To be eligible you need to be experiencing only mild distress on measures during our initial screening questions. If you currently have clinical depression or suicidal thoughts, or have ever had a diagnosis of, bipolar disorder (mania) or psychosis, you cannot take part because the study and the intervention is focused on promoting well-being and preventing poor mental health rather than treating current problems. However, you may be eligible for one of the other Nurture-U studies – for example a study of digital therapy for people with anxiety and depression and the screening website may guide you to these other studies. If you can’t take part, our automated pages can direct you to other sources of help and advice, and you can find more information at our website www.nurture-university.co.uk

Allocation to the Bounce Back intervention 

All eligible individuals within the study are selected at chance to either receive the intervention immediately or receive the intervention12 -14 weeks later. Treatment will be accessed through a written CBT intervention which will support you through the phases of the intervention. By comparing those that received the intervention immediately with those 12 - 14 weeks later we will find out if Bounce Back demonstrates potential to be effective, is acceptable, and also understand a little more about how successful the study has been.

How do I access the intervention? 

If the study is right for you and you consent to take part, just before starting to use the intervention you will receive an email indicating where on the University campus you can obtain the Bounce Back intervention. 

How long would I need to use the intervention for? 

You will be offered support in the use of the intervention for up to 6 weeks, and during this period can engage with it as often as you like. After this period you are free to continue to use the intervention if you wish to, but no support will be available. 

Do I have to take part? 

No, it is up to you to decide whether or not to take part. If you agree to take part you will need to sign a consent form online. Taking part is entirely voluntary. If you take part you are free to withdraw at any time without giving a reason.  

How will we use information about you?  

We will need to use information from you for this research project. This information will include your name, contact details (email, mobile number). We will use this information to do the research or to check your records to make sure that the research is being done properly. 

We will keep all information about you safe and secure. Once we have finished the study, we will keep some of the data so we can check the results.  

Is my data confidential and private? 

All information collected about you will normally be kept strictly confidential. The main exception is if in a support session you report significant difficulties or risk of harm to yourself. In this case, we may contact your doctor (if you provide their contact details). We would only contact your trusted contact (providing you choose to give us a trusted contact) if we were very concerned and were unable to reach you after one working day. 

Your information will be kept confidential and stored securely and password protected. Your contact details (name, email, telephone number) will be kept separately from all other data. Your responses on the website will be only linked to a project identification number, not with your contact details, to keep your personal responses private. 

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Who will have access to my data? 

Only selected researchers within the Nurture-U consortium can access your contact details. This is so they can contact you about follow-ups or to respond to your questions or requests for help. Other project researchers will only have access to the information you enter into the Website, linked to a code number. People who do not need to know who you are will not be able to see your name or contact details. In these cases, your name and contact details are replaced with a code number in the research data. That means that specific data can only be linked to a unique individual when this data is combined with other pieces of data, which are stored and protected separately. This is called in technical terms ‘pseudonymised data’. 

The third-party electronic shopping voucher provider will be given your name and email address only but no other information so they can send you access to the vouchers you have earnt. Your contact details will not be used by any party for sales or marketing purposes. 

The data you enter when you complete your screening, baseline assessment and follow-ups will be collected and stored in a secure password-protected information technology system managed by the University of Exeter clinical trials unit. 

The University of Exeter as the sponsor of the trial is the data controller with respect to your personal data, and as such will determine how your personal data is used in the study. 

As data controller, the University will take the appropriate measures to ensure your data is collected, transferred, processed, and stored according to relevant data protection legislation, including ensuring appropriate due diligence is performed on our data processors (who may perform tasks on our behalf, such as survey software or provide online therapy platforms).  

Our research team will process your personal data for the purpose of the research outlined above. Research is a task that we perform in the public interest. Further information about your rights with respect to your personal data is available from our privacy and personal data protection policy. 

The website routinely collect technical data such as hardware configuration, software configuration, access provider, data exchanges and site usage. We collect this so that we can run the website efficiently and keep your data secure. Technical data will not be linked to your contact information unless you ask us for technical support as we will need to contact you to provide help.

Free-text responses you provide in the intervention or online assessments may be used in the form of anonymous quotes on our advertisements, promotional materials, social media accounts or in future publications. You will not be named or identified in any quotes and any references to named individuals or contact details will also be removed.      

After the study ends it may be that academic journals and other research teams will ask for the data from the study to be made public (so they can carry out further research or check our findings).  The data they use will not include your name or any of your contact details. 

How long will my data be held? 

Your data will be kept for 10 years for research purposes only in line with good research practice. To safeguard your rights, we will use the minimally required Personal Identifiable Data possible. Our data protection and privacy policy is provided with this information sheet here. 

What if I want to withdraw from the study or delete my data? 

You can withdraw from using the Bounce Back intervention or taking part in the study at any time without giving us a reason, but we will keep information about you that we already have. Researchers need to manage your data in specific ways for the research to be reliable. This means that they won’t be able to let you change the data they hold about you. Research could go wrong if data is removed or changed.  

What are the possible disadvantages of taking part? 

Taking part involves giving of your time to complete the questionnaires and use the Bounce Back intervention. Because some of the questions in the assessment and following questionnaires ask about past and present negative emotions, there is a small chance that this may produce mild and brief upset if you are reminded of an unpleasant event. However, this would be no more than usually experienced in daily life. We are not aware of any other side effects, disadvantages or risks of using the Bounce Back intervention. 

What help is provided? 

The offer of support is provided during the 6 week use of the intervention. However, you are not obliged to use this support if you do not request it. If you report increased distress or thoughts of harming yourself on our website, we will give you automated advice and point you to sources of help. You can also contact us for further advice at any time and we will (wherever possible) respond within 2 working days. Your GP (family doctor) remains responsible for your medical care. It is your responsibility to contact them for further help.  

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What will happen to the results? 

We will analyse the information received from all those taking part together at the end of the study. We aim to publish the work in academic journals. Your identity will not be revealed in any report or publication. We will publish a summary of the findings on our website. We will also send this report to all participants who request it.   

Who has reviewed the study? 

This study has been reviewed and given a favourable opinion by the Psychology Research Ethics Committee at the University of Exeter and the contacts for this committee are Co-Chairs, Ciro Civile (c.civile@exeter.ac.uk) and Ian McLaren (I.P.L.McLaren@exeter.ac.uk).  

What if I have more questions? 

If you have any questions about taking part in the trial, please contact the Nurture-U Trial Manager, Dawn Phillips: telephone 07890 384247 and email Nurture-U@exeter.ac.uk   

If you wish to complain about any aspect of the research team’s work you can complain to the Study Principal Investigator, Professor Paul Farrand, University of Exeter, UK. 

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