We would like to invite you to take part in a research study conducted by King’s College London. The study will investigate how persistent fatigue can affect how people process information. It will explore whether we can change how the brain processes information using an online computer program.
Before you decide if you would like to participate, we will tell you why the research is being done and what it will involve for you. One of our team will go over this information sheet with you and give you the opportunity to ask any questions.
Research has shown that the experience of ongoing and persistent fatigue can affect how people process information. For some people, it can result in problems with attention and concentration. For others it can cloud how they see everyday activities, making planning and socialising difficult.
This research is interested in whether we can shift how people process information back to how it was before they experienced excessive fatigue. We are interested in whether shifting these processes can help reduce the distress caused by fatigue.
We have adapted an existing online program to make it specific to the experience of fatigue. The purpose of this study is to investigate whether this adapted online program is feasible; that is; is the program useful for patients who experience persistent fatigue.
If you agree to take part, you would be asked to complete some computerised training. There are two types of this training and you would be randomly assigned to complete one of them. One is an active version of the training and one is a neutral version. This is so that we can compare them. Both types of training consist of 12 sessions completed over 3 weeks (4 sessions per week). The sessions will last about 20 minutes and can be completed at home on a computer or tablet. You are able to select the days and time you wish to complete the sessions. In addition, you would complete some assessments online, before and after the 12 training sessions and again at 1-month and 3-months follow-up.
You have been invited because you have experience of persistent fatigue.
No, you do not have to take part. It is up to you if you would like to join the study. If you are interested in taking part, we will ask you to register your interest on the website and sign a consent form. You are free to change your mind and to withdraw at any time. This will not affect your standard of care. You do not have to give a reason for not wanting to take part.
Your personal information will be kept confidential. The questionnaires will be input into a computer. Only the researchers will have access to the computer which will have a password to protect all confidential files. Any personal details or identifiable information will be removed and contact details will be stored separately in a password encrypted file. The data will be kept securely at King’s College London. Contact details will be destroyed at the end of the study whilst consent forms will be archived up to seven years after the research has finished.
In the unlikely event of any risk such as self-harm or suicide risk, confidentiality will need to be broken. Your safety is very important. Both you and your clinical team will be made aware of the breach of confidentiality.
Data will also be stored on an online platform. Questionnaires will be completed on Qualtrics whilst the training will be conducted using a website developed and hosted by SPIKA (for privacy statements, please see links: https://www.qualtrics.com/privacy-statement/ ; https://www.spika.com/privacy-policy/ ).
How your personal data will be used in compliance with General Data Protection Regulation (GDPR)
King’s College London (KCL) is the lead sponsor for this study based in the United Kingdom. We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. KCL will keep identifiable information about you for 7 years after the study has finished. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order 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 by contacting the Chief Investigator Dr Alicia Hughes; email@example.com, or visiting the KCL website: https://www.kcl.ac.uk/research/support/research-ethics/kings-college-london-statement-on-use-of-personal-data-in-research.aspx .
If you were recruited from South London and Maudsley NHS Foundation Trust, they 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. South London and Maudsley NHS Foundation Trust will pass these details to King’s College London along with the information collected from you. The only people in King’s College London who will have access to information that identifies you will be people who need to contact you to regarding the research or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name or contact details.
The risk of taking part is extremely minimal. You can complete all parts of this study at home. The online program has been used before without any adverse effects. The assessments have also been used previously and should not cause any distress.
The study requires a 3-week time commitment from participants, in order to complete all 12 online sessions. To reduce the burden of this on participants we have made each session as short as possible. There is also a visual calendar built into the website to help you plan to complete these sessions.
This study is investigating whether a program like may be useful for people with fatigue, however in its current form it is not viewed as a therapeutic intervention. Whist participants may not directly benefit from this study, the research is aimed at further understanding factors which contribute to fatigue. This knowledge can help us identify ways to help reduce the distress and disability fatigue can cause in people’s lives.
If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions [Alicia Hughes, 0207 188 5422, firstname.lastname@example.org]. If you remain unhappy and wish to complain formally, you can do this through the South London and Maudsley Patients Advice and Liaison Service (PALS) on 0800 731 2864, email@example.com.
The results of this study may be published in scientific journals and at medical and psychological academic conferences. You will not be identified in any report or publication. A lay summary will be sent to participants.
This study has been checked by Research Ethics Committee, an independent group of people, to protect your safety, rights, wellbeing and dignity.
If you have any questions or concerns about the study, you may contact the following organisationsFor independent advice on participating in NHS research:
Patient Advice and Liaison Service (PALS) - 0800 731 2864For independent advice about making a complaint:
South London Independent Complaints Advisory Service (ICAS) – 0300 456 2370For information from the researchers: