How effective is FITNET-NHS for children and young adults with CFS/ME
Information Leaflet for Young People Aged 11-15 Years
We would like to invite you to take part in a research study which will tell us which of two treatments, FITNET-NHS and Activity Managements, is more effective at helping young people with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis. Before you decide whether you would like to take part, it is important for you to understand why the study is being done and what it will involve. The leaflet is divided into two parts. Part 1 tells you about the study and what will happen to you if you choose to take part. Part 2 gives details about how the study will be run. Please read this leaflet carefully. You can talk about it with your family, friends, doctor, or us. Ask us if there is anything you don’t understand or if you want more information. Take time to decide whether or not you want to join in. Thank you for reading this.
PART 1 Why are we doing the study?
We want to test whether a treatment called “FITNET-NHS”, which delivers cognitive behavioural therapy (CBT) for CFS/ME at home via the internet, is effective and value for money. CBT focuses on cognitive behavioural strategies to identify, challenge and change cognitive (thinking) processes.
We want to compare this with another treatment for CFS/ME called Activity Management which will use video call (e.g. Skype).
In the first part of the study, we want to know whether young people, like you, will want take part in the study and whether young people think FITNET-NHS and Activity Management are acceptable treatments.
In the second part of the study, we want to see how effective FITNET-NHS and Activity Management are at treating young people with CFS/ME and measure the costs of each treatment.
Why have I been asked to take part?
You have been asked to take part in this study because you are aged between 11 and 17 years, have a diagnosis of CFS/ME, and do not have a specialist CFS/ME service close to your home.
If you are not able to attend telephone or online consultations required for the research study (e.g. you don’t have a phone line or internet/video call (e.g. Skype) access at home), you will not be able to take part.
Do I have to take part?
You do not have to take part in this study. If you agree to speak to the research nurse, they will explain more about the study. This will not commit you to taking part.
If you think that you might not want to take part in any of the treatments, you should not enter the study.
We hope that up to 734 young people and their parents/carers will take part in this study but it is up to you to decide whether or not you would like to take part.
FITNET-NHS IRAS ID: 211202
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If I agree to take part can I change my mind?
Yes. If you decide you would like to take part but change your mind later, we will continue to follow you up like we do other young people who are not part of the study unless you tell us you don’t want us to.
You can leave the study at any point and, if you would like us to, we will take out the information collected about you at any point before we carry out data analysis.
Leaving the study at any time will not affect the standard of medical care you will receive.
What will I be asked to do if I take part?
Before the treatment:
If you would like to hear more about the study, the research nurse will arrange a time to talk to you over the telephone. The research nurse will explain the study to you and your parents/carers, and answer any questions you may have. With your permission, this discussion will be audio-recorded and will last about 45 minutes, but you can talk for longer if you have more questions. The research nurse might ask you about how you felt when you were asked if you wanted to take part in this study.
If you want to take part in the study, you will be asked to fill in an on-line assent form to show us that you agree.
If you take part in this study, we need to make sure that participants in both groups are as similar as possible. This is the only way we can compare the groups and make sure the study is fair. You will therefore be allocated to either Activity Management or FITNET-NHS by a process of randomisation. Half of those taking part in the study will receive Activity Management and half will receive FITNET-NHS, so you will have a 50% chance of getting either treatment. Both treatments have been used before.
During the treatment:
You will receive treatment for your CFS/ME at home. Both groups will get lots of advice from members of Bath Specialist CFS/ME Service about how to improve your sleep and you will get treatment for your symptoms. You and your parents/carers will need to complete questionnaires at baseline, 3 months, 6 months and 12 months which will take you about 20 minutes each time.
We want to find out more about what you think about this study. A researcher may ask to meet with you or speak with you and your parents/carers over the phone to find out what you think about the study or the treatments. This discussion will be audio-recorded with your permission. This may last around 30 minutes. It is up to you if you want to do this or not.
In addition you will get either Activity Management or FITNET-NHS.
Activity Management If you are in this group you will receive up to three video (e.g. Skype) calls. During the first video (e.g. Skype) call, you will have a detailed assessment of the activity you do. This will take around 90 minutes. This includes thinking activity such as school work, homework, time on the computer and screens, reading and hobbies that require concentration and physical activity such as walking or PE. We call this high energy activity. We will ask you to record your activity on paper or our iPhone app “ActiveME”. We will then help you find your “baseline” activity which is the average amount of activity that you can do each day. When you have found your baseline activity, we will provide follow up video (e.g. Skype) calls to help you increase this by 10-20% each week. Each follow up call usually takes around 60 minutes. This is called Activity Management.
FITNET-NHS IRAS ID: 211202
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FITNET-NHS If you are in this group both you and your parents will have to work through 19 interactive cognitive behavioural therapy (CBT) treatment modules on-line. Each module will take about 60 minutes to complete. These modules will explain what CBT is and how it works
. CBT focuses on cognitive behavioural strategies to identify, challenge and change cognitive (thinking) processes. It also helps you develop treatment goals and discusses the role of your family in the treatment process.
Your parents will also have to work through modules separately in which they will explore their beliefs and behaviours towards your CFS/ME and focus on their role as carers. The therapist will work with you and your parents and provide weekly online consultations to review homework and support you.
What is the difference between the two treatments?
Activity Management will mainly be working on activities that take up most of the day like school work, setting a baseline and trying to increase it. It does not focus on changing behaviours and thought processes.
FITNET-NHS will try to focus on cognitive behaviour strategies to change thought processes to allow you to reach a goal which you have set for yourself.
Are there any disadvantages to taking part in this study?
You will need to spend time talking to a research nurse for about 10 minutes so we can understand if you are interested in the study. You and your parents/carers will need to arrange a time to talk on the phone to a research nurse about the study. This will take about 45 minutes.
If you take part, you will have to spend time completing the treatment. For Activity Management this will be about 90 minutes for the initial assessment and 60 minutes for each follow up call. For FITNET-NHS you will spend approximately 60 minutes on each on-line module. We think your parents will spend about 10 - 15 minutes on each module.
If you take part, you and your parents/carers will need to complete questionnaires at baseline, 3 months, 6 months and 12 months. We ask all young people to complete these questionnaires. These questionnaires will take you about 20 minutes each time.
You may not find the treatment you are offered helps you. Young people with CFS/ME can get worse even with the treatment offered and we do not know how many will get worse (or better) with either Activity Management or FITNET-NHS. This is why we are doing a study. Will I experience any side effects from taking part in this study?
We have used Activity Management and face-to face CBT in our service and are not aware of any side effects. A study of on-line CBT treatment for children with CFS/ME has also shown that there were no side effects.
What are the benefits of taking part in this study?
You may feel better from the treatment you are undergoing, but we cannot say this for certain. You may learn something about how a research trial works. Some young people with CFS/ME like to know that they are helping others with CFS/ME in the future. What will happen when the study stops?
After the study stops, you can continue to have medical care from your local team if you still need it. If you want to know the study results, let us know and we can send them to you.
FITNET-NHS IRAS ID: 211202
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PART 2 If you are still interested in taking part in this study, please read the information below before making your decision.
Consent
We have to be completely certain that you are happy to join this study, so we will ask you to sign an assent form. We will also ask you to sign one of these forms if you are happy for us to record discussions with you. Once you have signed the forms, you will still be free to stop the recording or leave the study at any point. Just tell us if this is the case. Whether or not you wish to take part, you will continue to receive the same care from the clinical team.
What will happen to the information you collect about me?
It is very important that all the information you give us is completely private. The conversations that you give us permission to record will be encrypted and password protected (so that only members of the study team can listen to them). They will be stored on a secure University of Bristol server.
We will use a research code to identify you. No name or personal information will be on the questionnaires we send you. All personal details that could identify you will be kept secure in locked cabinets in locked offices or password protected on secure NHS or University of Bristol computers.
We may use some of the things you say when we write about the study but we will take your name and any other information off so no one will know who was speaking. We would also like to keep the things you say so that other researchers can use it for research and teaching now, and in the future. We will check you are happy for us to use the things you say in this way. If you tell us something that makes us worried about your safety or the safety of those around you, we may have to discuss this with somebody else. This means, what you say would not be kept completely private if we were sufficiently concerned about you or those around you. We would do the same if you told us something in clinic.
What will happen if I feel unwell during the study?
If during the course of the study you start to feel unwell (e.g. if you feel anxious or depressed, or if you have a fever), you should speak to your parents and contact your local care providers (e.g. your GP or paediatrician). The research team provide specialist treatment for CFS/ME but cannot provide treatment for other problems you may have. If you do contact the CFS/ME research team about other concerns (e.g. feeling anxious or depressed), the research team will do their best to help. If they feel it’s appropriate they may pass the information on to your local care providers and try to inform you of other services which may help you. The CFS/ME research team may not be able to reply to your queries straight away (e.g. if you send the research team a message with concerns on a Saturday it may not be picked up until the Monday). This is why you should always speak to your parents and contact your GP if you have any concerns. Does everybody involved in the study have the right police checks?
Yes. All those working in the study have had police checks to make sure they are safe to work with children and young people.
FITNET-NHS IRAS ID: 211202
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Who will know that I am taking part in the study?
Your GP should know that you are taking part in this study so we will write to them to tell them which treatment you will be receiving in the study. What will happen to the results of the study?
This study will give us information on whether young people are interested in taking part in a study like this and whether they think the “Activity Management” and “FITNET-NHS” treatments are acceptable. It will also tell us how effective these treatments are at helping young people with CFS/ME and how much the treatments cost.
What if new information becomes available whilst I am in the study?
If new information becomes available, we will tell you about it and discuss whether you want to continue in the study. Who is organising and funding the study?
This research is organised by Professor Esther Crawley who leads the Bath Specialist CFS/ME Service and the CFS/ME Research team at the University of Bristol.
The study is funded by the government’s research fund - the National Institute of Health Research (NIHR) and is sponsored by the University of Bristol. What should I do if I have a problem with the study?
If you have any problems with this study, please speak to your parents/carers, Professor Esther Crawley, or any member of the clinical team that you know. Professor Crawley’s contact information can be found at the end of this information leaflet.
You can also complain to the NHS in the usual way through the Patient Advice and Liaison Services (PALS) on 01225 473424. Will I need to pay to be part of this study?
No. Ethical Approval
Ethical approval means that this study is safe to carry out on young people. The study has been approved by South West – Frenchay Research Ethics Committee. Who can I contact for further information? Prof Esther Crawley - Paediatric Consultant/Clinical Lead of the Paediatric CFS/ME Service Address: Paediatric CFS/ME Service, Children’s Centre, Royal United Hospital, Combe Park, Bath, BA1 3NG Tel: 01225 821340 Email:
esther.crawley@bristol.ac.uk Or if you want to talk to somebody independent please contact: Jane Carter - Research Lead Address: RUH Bath NHS Foundation Trust, Combe Park, Bath, BA1 3NG Tel: 01225 465941 Email:
jane.carter14@nhs.net
THANK YOU for taking the time to read this leaflet