The effectiveness of an application for treating depression and anxiety symptoms in a subclinical student population

We would like to invite you to take part in a research study. Your participation is completely voluntary. Before you decide, it is important you understand why the research is being done and what it will involve.  Please read the following information carefully and discuss it with your friends and relatives if you wish.  Please feel free to email us on BSFtrial@thrive.uk.com (researcher) or  a.fonseca (at) ucl.ac.uk (principal investigator) if there is anything that is not clear or if you would like more information. Take your time when deciding whether or not you wish to take part. If you do decide to take part, you are still free to withdraw at any time and without giving a reason. This study has been approved by the UCL Research Ethics Committee (Project ID: 8227/001), and by the University of Roehampton Research Ethics Committee (Project ID: PSYC 16 205).

What is the purpose of the study?

We want to find out if feelings of depression and anxiety can be reduced with an online application. Our application aims to target these feelings, using all the techniques we know work when used in a face-to-face therapy session.

We believe the application will enable the person to reduce these symptoms themselves without direct contact with a therapist. If this is true, individuals who are suffering with feelings of depression and anxiety would be able to recover without needing to go through their general practitioner (GP) and without needing to wait for treatment or pay to receive it privately.

What are the benefits and risks associated with participating?

We hope that the application will help with reducing your feelings of depression and anxiety. The application also contains various relaxation exercises to try, which you may benefit from. We have tried to make the application as fun as possible so we hope that at the very least it will provide entertainment. If you decide to participate you may keep the application free of charge for as long as you would like.

It is extremely unlikely that you will experience any distress as a result of participating in this research and there are no major risks involved. Full support/treatment service information will be provided to anyone experiencing distress during the study.

Who would we like to participate?

We would like to invite any students who have feelings of depression and/or anxiety to participate in the study. To participate, you will need to own either a computer, an iPhone, iPad, Android phone or tablet.

What would it involve?

If you agree to take part in this study you will be asked to fill out a brief questionnaire involving some personal information such as your age and gender. We will also ask you to complete a questionnaire that will tell us about the symptoms of depression and anxiety you are suffering from currently. You will then either be given access to download the application immediately or be put on a waiting list. Those who download the application immediately will be asked to use it at least once per week for 6 weeks, and answer questions about their feelings of anxiety and depression every 2 weeks. A group of those on the waiting list will also be asked to complete these questionnaires. For both groups there will also be follow-up questionnaires 2, 4 and 6 after the end of the trial.

We estimate the time commitment to be approximately 2-3 hours in total, across the total 12 weeks of participation (including the intervention period and follow-up questionnaires). All of this can be done in your own time, alone, wherever you prefer, as long as you have access to the internet and the device needed for the application.

Will my taking part in this study be kept confidential?

Yes. All information collected about you will be kept strictly confidential and secure, with password protection and advanced encryption of data in place at all stages. All data will be collected and stored in accordance with the Data Protection Act 1998, and only the research team will have access. We hope to publish the results of the study in a medical journal, but nothing that would identify you will be mentioned.  We will make the results of the study public through the website www.thrive.uk.com, but again all participants will be completely anonymous.

Who has reviewed this study?

Before any research of this kind can be conducted, it must be reviewed and approved by a research ethics committee. The University College London and University of Roehampton Research Ethics Committees have reviewed and approved this study.

Please discuss the information above with others if you wish or ask us if there is anything that is not clear or if you would like more information. You can contact us at BSFtrial@thrive.uk.com or a.fonseca (at) ucl.ac.uk at any time. We would be happy to provide you with a copy of the final report at the end of the study, if you are interested.

It is up to you to decide whether to take part or not; choosing not to take part will not disadvantage you in any way. If you do decide to take part you are still free to withdraw at any time and without giving a reason. You can do so by sending an email to BSFtrial@thrive.uk.com, or simply by not filling out the weekly questionnaires. If you would like to take part, please follow the link below which will take you to the consent form. Remember to use your participant ID when filling out the consent form - this is on the email you received with the link to this information sheet.

Thank you for reading this information sheet and for considering taking part in this research.