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Participant Information Sheet

Can online Cognitive Behavioural Therapy lead to sustained improvements in mood and other key outcomes in people caring for individuals with dementia? : A randomised controlled trial.

Short Study Title: Caring for Me and You: A toolkit for carers of people with dementia

Invitation to take part in a research study

We would like to invite you to take part in our research study. Before you decide, we would like you to understand why the research is being done and what it would involve for you. Please read through this information sheet, and if you have any further questions, please contact a member of the study team (details of how to contact us by e-mail and our telephone helpline can be found at the end of the participant information sheet). We’d suggest this should take about 20 minutes. Talk to others about the study if you wish.
(Part 1 tells you the purpose of this study and what will happen to you if you take part. Part 2 gives you more detailed information about the conduct of the study).

Part One

What is the purpose of the study?

To find out whether a computerized psychological treatment Cognitive Behavioural Therapy (CBT), with or without telephone support or an on-line education and information package about dementia is helpful in reducing feelings of stress or low mood for people caring for someone with dementia.

Why have I been invited?

We are inviting everyone who is over 18 and a friend or family member caring for someone with dementia to consider taking part in this study to find out if cognitive behavioural therapy or on-line education and information package about dementia is helpful in reducing feelings of stress or low mood. We are looking for 750 people to take part and help us with the study. If you complete our screening questionnaires you will be eligible to take part if your scores indicate a mild degree of anxiety or depression, which is very common for people caring for someone with dementia.

In order to participate, you will also need to:

  • be comfortable with the English language
  • have the ability to use a computer with internet access.
  • Be living in the UK

Do I have to take part?

It is up to you to decide to join the study. The information sheet will describe the study in more detail to help you make your decision. If you agree to take part, you will then need to read and sign a consent form. You are free to withdraw at any time, without giving a reason. This would not affect the standard of care you receive through your own General Practitioner or local NHS services. This study does not replace those services and if you feel less well during the time you are part of this study it is important that you seek help from your doctor or local health professionals in the usual way.

Why are we doing the study?

Caring for someone with dementia can be challenging and stressful, and it can be difficult to access the right help and support. Often carers of people with dementia are offered educational materials and information so that they are better informed about ways to provide care and what can be helpful for the person they care for and therefore improve how they feel themselves. The psychological therapy Cognitive Behavioural Therapy (CBT) is a well established treatment for anxiety or low mood and has been shown to help people feel more able to cope with stressful situations. The therapy is usually given by a trained therapist in person, but there is also evidence that it can help improve low and anxious mood as a computerized psychological treatment supported by telephone calls from a therapist.

Until now the use of computerized CBT has not been available specifically for people who may experience stress as part of their caring role for someone with dementia. However we would like to know whether a specially adapted version of CBT designed to be delivered on line is a helpful treatment and whether telephone support is also needed for carers to be able to use the programme effectively. If computerized cognitive behavioural therapy can help provide support and benefit to carers of people with dementia this could be an effective way of helping thousands of people who find it hard to find time to visit a therapist or other forms of help and support. The purpose of the current study is therefore to find out whether an online education and information package about dementia or computerized cognitive behavioural therapy, with or without telephone support, is effective in helping people caring for individuals with dementia. 

What will happen if I take part?

If you take part, you will first be asked to provide some general information, such as your age and gender, and asked to complete some questionnaires about your health, your mood, how you feel and how much stress you are under. These questionnaires will take about 30 minutes to complete. People whose scores on the questionnaires show they experience mild or moderate levels of anxiety or depression will be eligible to take part in this research. You will then be asked to provide details of your General Practitioner – whom we would only contact if you had increasing health problems during your participation in the study.

Those who are eligible and want to to take part in this research will then be allocated to one of three treatment arms: computerized cognitive behavioural therapy with telephone support, computerized cognitive behavioural therapy without telephone support, or an online education and information programme about dementia. Your involvement in the study could last up to 6 months. Each intervention is divided into 20 sessions lasting approximately 20 minutes each, which can be done once a week or more frequently depending upon your preference. You are able to complete as many sessions at a time as you wish. If you do not complete any sessions for a period  of 7,14 or 28 days, you will receive an email  reminder about this project unless you tell us that you want to stop being part of it by using the “ discontinue” button in the programme.  You will also receive emails at the end of each session to remind you how much of the programme you have completed. You will be asked to complete further questionnaires about your mood, your stress and how you feel after 12 weeks and again in week 26. These questionnaires in week 12 and 26 take approximately 30 minutes on each occasion.

If you are not eligible to take part in the study you will be offered access to the online education and information package about dementia if you wish to use it. In this situation we will not collect any other information from you and your information will not be included in the study. We hope that the education and information package about dementia is helpful, but it is not intended to replace other services and if you feel less well it is important that you seek help from your doctor or local health professionals in the usual way.

What are the possible benefits of taking part?

You will receive either high quality information about dementia or a computerized cognitive behavioural therapy treatment which is similar to treatments that have been shown to be effective for people with depression or anxiety. It is therefore possible that the treatment will give participants some direct benefits in terms of having some new knowledge about dementia and ways to care and to deal with their emotions. Equally importantly though, this is an important scientific study which has the potential to help thousands of people caring for individuals with dementia in the future.

What are the possible risks of taking part?

You may find that the time you take to do the sessions and questionnaires causes you additional pressure and are therefore difficult to complete. A few people find that thinking about their situation can also make them feel low in mood or more stressed. In these situations you are free to stop participating in the research and it is important that you seek help from your own doctor and local health professionals to decide what treatments, if any, are most suitable for you. This project is not intended to replace the regular healthcare that is available to you where you live.

What happens when the research study stops?

After the 6 month trial, the treatment will end and you will be asked to complete questionnaires about how you are feeling at 12 weeks and at 26 weeks after you first signed up. The whole project runs for 12 months and when we have collected everyone’s data the results will be analysed.  Results will be published in a scientific journal and communicated more widely through an online newsletter. If any of the treatment is effective it will be made available as a routine therapy. The information collected is totally confidential and no individuals will be identified in any publications.

What if there is a problem?

Any complaint about the way you have been dealt with during the study or any possible harm you might have suffered will be addressed. The detailed information on this is given in Part 2.

Will my taking part in the study be kept confidential?

Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. The details are included in Part 2.

If the information in Part 1 has interested you and you are considering participation, please read the additional information in Part 2 before making any decisions.

Part Two

What if relevant new information becomes available?

Sometimes we get new information about the treatment being studied. If this happens and the study needs to stop you will be sent an email to explain why the study has been stopped and given some advice about the organisations who may be able to provide support and advice. If you feel you need individual help in your caring role then you need to contact your local doctor to discuss your needs.

What will happen if I don’t want to carry on with the study?

You can withdraw from the study at any time without giving a reason. If you withdraw from the study you can tell us whether you want information collected up to the time you withdraw in the analysis or whether you would like us to destroy that information. 

What if there is a problem?

If you have a concern about any aspect of this study, you should use the help button in the online programme to contact the researchers who will do their best to answer your questions. You can also call: 01865 902833.

If you remain unhappy and wish to complain formally, you can do this. You can contact the NHS Oxford Health Foundation Trust Patient Advice and Liaison Service. Details can be obtained here, or by emailing PALS@oxfordhealth.nhs.uk

Indemnity procedures are in place through Oxford Health NHS Foundation Trust to ensure that compensation is provided for any injury or significant harm caused by taking part in the study that is the result of negligence. However, such injury or significant harm is highly unlikely.

In the event that somebody does do wrong and you are harmed during the research and this is due to someone’s negligence then you may have grounds for legal action for compensation against Oxford Health NHS Foundation Trust, but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you (if appropriate).

Will my taking part in this study be kept confidential?

Research data will be collected on line from the answers to the questions you complete at the start of the study, after 12 weeks and at the 26th week of the study. This will be totally confidential and will be kept securely in line with Data Protection principles and compliant with the Data Protection Act (1998). The study database will not include your name, just a study number.  During the study we will keep a separate secure list linking your name, study number and contact details, so that we can get in touch to offer you help if that is needed. However, once you have completed the study, your data will be completely anonymised and it will not be possible to identify you. The data will only available to the study team for analysis.

During the online sessions you will be asked to rate how you are feeling. If  you experience a significant increase in your levels of distress on this rating scale an automatic alert will be sent to the research team. An automatic email will also be sent to you to ask whether you wish us to contact you to discuss where you may find additional forms of support and inviting you to supply a contact number to enable us to do so. We will also contact your GP to let them know that you are taking part in the study and  are experiencing increased levels of distress, so that they can consider how best to support you through your local health care team, if necessary.

If, during the course of the research trial, you share information which raises concerns about the safety of others in your care, then the research team will follow standard NHS procedures to seek and follow advice from the local safeguarding team.

For those people randomised to the telephone support condition, the contact with the telephone support worker will be recorded as part of an NHS record.

Study data will be retained in line with legislation – which is currently for 7 years -  and will be deleted securely at the end of the period. The stored data will be fully anonymized and coded by study number.  It will not include any names and it will not be possible to link it to any individuals once it has been anonymized.

What will happen to the results of the research study?

Results will be obtained from anonymized data and those findings will be presented at national and international meetings, published in medical journals and made available in an on-line newsletter. No individual participant will be identified in any publication or meeting.

Who is organising and funding the research?

The lead investigator is Dr. Jane Fossey, a consultant clinical psychologist working for Oxford Health NHS Foundation Trust. Oxford Health NHS Foundation Trust will be sponsor for this study and they will be responsible for making sure that the study is run in a proper way. The study is being funded by the Alzheimer’s Society.

Who has reviewed the study?

All research in the NHS is looked at by an independent group of people called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by South Central Oxford B Research Ethics Committee (reference number: 13/SC/0117)                  

Further Information

Thank you for taking the time to read the information about this trial. If you would like to take part, click the link below to view the consent form. If you would like more information about the study before you decide whether or not to take part, a more detailed description is available on the Alzheimer’s Society website or you can contact a member of the study team at the Alzheimer’s Society by ringing the CBT study help and information line 01865 902833 which is also provided on the link above.

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