Sussex Psychosis Research interest Group (SPRiG)

STructured lifestyle Education for People WIth SchizophrEnia

STructured lifestyle Education for People WIth SchizophrEnia
including people with experience of psychosis and a diagnosis of schizoaffective disorder

What is the purpose of the research?

We want to find out whether an education programme designed for people with experience of psychosis or with a diagnosis of schizophrenia or schizoaffective disorder is more likely to help reduce weight than usual information and advice provided by the NHS.

The group education programme has been successful in improving diet and physical activity for people with diabetes and those at risk of diabetes. We know that the programme can also be adapted for other patients but we do not yet know whether it can help people with psychosis and taking antipsychotic medication to lose weight. We know that taking antipsychotic medication can lead to weight gain and people taking these medications can find it more difficult to manage their weight.

Losing weight can help reduce the risk of developing health problems such as diabetes and heart disease in the future. Everyone who joins the study will continue to receive their usual treatment provided by their community mental health team. The education programme has been developed with the help of people with psychosis who want to lose weight. People with psychosis and a carer are also involved in the management of the study.

Why have I been invited?

You are being invited to take part in this study because your Mental Health Trust are taking part in the study. We are inviting people with experience of psychosis or have a diagnosis of schizophrenia or schizoaffective disorder (e.g. hearing things that other people don’t hear) and who are also overweight or concerned about weight gain since starting antipsychotic medication.  .

Do I have to take part?

No. It is up to you to decide whether or not to join the study. This information sheet describes the study and a member of the research team will talk it through with you and answer any questions you may have. If you agree to take part, we will check that the study is right for you and then ask you to 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.

What will happen if I agree to take part?

If you agree to take part, you will continue to receive your usual care. Taking part in this study will not affect or change your current medication.  Your involvement in the research will last approximately 12 months. If you agree to join the research study we will ask you to answer some questions and complete the assessment explained below.  

Questionnaires

You will be asked questions about your: symptoms; mood; diet; exercise; use of NHS services and your views on risks to your health.

Wrist watch

We will then ask you to wear a wrist band (like a watch) for 7 days to measure your physical activity. You will not be able to see anything on the watch. This is to make sure it does not influence the research study.

Body measurements

To monitor your physical health we will measure your weight, waist and blood pressure.

Blood test

A trained researcher will take a small sample of your blood (the equivalent of a few tablespoons). The purpose of the blood test is to check your blood sugar, cholesterol, and fat levels to assess your risk for diabetes, heart disease and other related health problems. These blood tests are recommended by the UK National Institute of Health and Care Excellence (NICE) and should form part of your routine care. Where possible, we will combine the blood tests with these routine tests. Blood samples will be processed in the normal way. Your care coordinator or key worker will be informed of the results and you can ask them about your results at your next appointment. Your blood test results will also be shared with your GP.

The blood test will only take a few minutes. On the day before the test, you should not eat or drink anything from midnight and we will take the blood sample first thing in the morning. This is so that the blood fat and sugar levels can be compared easily and don’t just tell us about how much fat or sugar you had for breakfast! It will take approximately one hour to complete the assessments. The researcher may collect the blood sample on a separate day to your other assessments e.g. when they collect the watch from you.

Which part of the study will you be in?

After the assessments, you will be randomly allocated to one of two study groups:

Group 1 - usual care consisting of physical health review and verbal and printed advice on the risk of weight gain and lifestyle advice, including information about diet, exercise, smoking and alcohol use;

Group 2 - education programme delivered by two trained facilitators plus usual care.

You will not be able to choose the group. Sometimes we don’t know which intervention works best for service users. To find out, we need to give the people in one group a different intervention to the other group. The results of both groups are then compared to see if one intervention is better. To try and make sure the people in the groups are the same at the start of the study, a computer will decide whether you go into either group 1 or 2.

What will happen to me after I have agreed to be involved?

If you are allocated to study group 1 you will receive usual health and social care. You will not receive the education programme.

If you are allocated to study group 2 you will be contacted by the programme coordinator who will invite you, to attend the education programme.

Education programme

The programme is run in groups of approximately 6-8 participants. The size of the group may be smaller or larger depending on the numbers that attend. Two trained facilitators will run each session. The sessions will focus on what it means to be overweight or concerned about your weight and how it links to medication, food and physical activity. The sessions will also focus on strategies to help manage weight and next steps, e.g. setting goals to help manage weight.

The programme sessions will take place each week for about two and a half hours (including breaks) and last for a 4 week period. To get the most out of the group, it’s important to attend the whole session each week. There will be a refresher session at 4 months, 7 months and 10 months after you started the programme. One session will include an opportunity for participants to join in a practical fitness band (“Theraband”) activity. The facilitator will also remain in regular contact with you throughout the year.

Research follow-up

All participants will be contacted by a researcher at 3 months after joining the study to repeat the questionnaires and measurements. This will help us to find out if usual care or usual care + the education programme works best. A researcher will contact you again at 12 months to repeat the assessments (including blood test) which will help us to find out which works best after a longer period of time.

The researcher asking you questions and taking measurements at 3 and 12 month follow-up will not know which group you have been allocated to. This is important because sometimes knowing this can influence the results of the study. You will be reminded not to tell them.

If you are allocated to study group 2 an observer from the University Hospitals of Leicester NHS Trust may attend some sessions. They will sit at the back and observe the facilitators (e.g. make a note of how often the facilitator talks during the session). They will not participate actively in the group.

Optional interview

If you are allocated to study group 2 you may also be invited to take part in an optional interview to tell us about your experiences of taking part in the education programme. This interview will be audio-recorded.

Are there any expenses or payments involved?

All participants will be reimbursed travel expenses for attending appointments relating to this study (e.g. to fill in questionnaires). Travel expenses will also be paid or transport provided (e.g. taxi) to participants invited to attend education sessions (group 2). All participants will receive a £20 voucher if they complete follow-up assessments at 3 and 12 months. You will receive the voucher at the 12 month time point. This is in recognition of your time and should not impact on any benefits you receive.

Will my taking part in the study be kept confidential?

If you decide to take part, we will inform your GP. All information that is collected about you during the course of this study will be kept strictly confidential. If the research team become aware of anything during the study that may put you at risk they will inform your care team. We will always try to discuss this with you first. The information will be stored in a secure area of the Sussex Partnership NHS Foundation Trust. Information will be entered onto a secure database which is managed by the University of Sheffield. We will destroy all identifiable information six years after the end of the study. An anonymised copy of the computer file (with any details that might identify you removed) will be retained and made available to other researchers for use in future studies. Only authorised persons such as researchers and regulatory authorities will have access to view data that can identify you. This will include the University of Sheffield in order to monitor the quality of the research being carried out. Some documents (e.g. consent form) will be sent by post to the University of Sheffield.

If you are in group 2, your contact details will be shared with trained facilitators who are employed by Sussex Partnership NHS Foundation Trust. A list of participants who attend each session and feedback forms will be sent to the University of Sheffield by post. Other people in the education programme group will know you are taking part in the study but you do not have to tell people your full name or where you live. If you are in group 2, with your agreement, your name and contact details will be shared with the University of Sheffield. This will enable them to invite you to take part in the optional interview about your experience of being involved in the education programme. The information recorded during these conversations will be written down and the recordings will be destroyed; any direct quotations appearing in publications will be anonymous.

We will destroy all identifiable information six years after the end of the study. An anonymised copy of the computer file (with any details that might identify you removed) will be retained and made available to other researchers for use in future studies.

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

You can decide to withdraw from the study at any time and, if necessary, let us know if you no longer want to be contacted. If you do wish to discontinue, you do not have to give a reason and this will not impact on the care you receive from your care team. If you are unable to continue we keep the data we have collected up to that point.

What if there is a problem?

We do not think that taking part in this research will be different to receiving treatment outside the study but if you have a concern about any aspect of this study, you should ask to speak to the researcher who will do their best to answer your questions, or contact the study

team (contact details below).

If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details can be obtained from the Trust.  In the event that something does go wrong and you are harmed during the research and this is due to someone’s negligence then you may have grounds for a legal action for compensation against Sheffield Health and Social Care NHS Trust or Sussex Partnership 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: PALS, Sussex Partnership Trust, Swandean, Arundel Road, Worthing, West Sussex, BN13 3EP, telephone: 01903 843022,  email: pals@sussexpartnership.nhs.uk

What are the possible risks and benefits of taking part in this research?

Previous research studies suggest that lifestyle education programmes can lead to reductions in body weight and diabetes. People often feel better if they choose to increase the amount of exercise they do and eat a healthier diet. The study is unlikely to cause you harm but it is possible that you may injure yourself through doing physical activity you are not used to. Although similar forms of therapy have been used to address the issues outlined above, this therapy has not previously been offered to people with mental health problems. Although no adverse effects are anticipated, the education programme may not help people to lose weight or prevent weight gain. Should you experience any upset whilst taking part in the study, you can tell the research team (or programme facilitator if you are in group 2). They will offer guidance and also contact your care team for ongoing support (if required).

Blood tests: The risks involved are those of ordinary blood tests such as slight scratch and occasionally a small bruise from where the sample is taken.

What will happen to the results of the research study?

This research will take place over about three years, after which the results will be presented at academic conferences and published as academic reports in scientific journals. The results of the research will contribute to better understanding about the care and treatments that are offered to people experiencing psychosis or have a diagnosis of schizophrenia or schizoaffective disorder. You will not be identified in any presentation, report or publication. You will be able to access the results of the study on the University of Sheffield website at: http://www.shef.ac.uk/scharr/sections/dts/ctru/stepwise.

Who is organising and funding the research?

The research is organised by the University of Sheffield on behalf of Sheffield Health and Social Care NHS Foundation Trust (sponsor). The sponsor will pay Sussex Partnership NHS Foundation Trust for including you in this study. The research is funded by the National Institute for Health Research, Health Technology Assessment (NIHR HTA) Programme.

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 safety, rights, wellbeing and dignity. This study has been reviewed and given a favourable opinion by Yorkshire and The Humber - South Yorkshire Research Ethics Committee.

Further information and contact details:

Remy Gray: 07909 256492 Remy.Gray@sussexpartnership.nhs.uk

Kelly Wilson: 07738 757328 Kelly.wilson@sussexpartnership.nhs.uk

Main Office number: 01273 265921