The Social Health Cohort Study

• This research study is recruiting ‘healthy volunteers’ – people without a current diagnosis or history of mental health conditions. Healthy volunteers provide a reference (control) group in the study allowing us to compare people with and without mental health conditions.
• You have been invited to take part as you are aged 18–95 and do not have current or past mental health conditions, you are not taking psychiatric medication and you have told us that people in your immediate family (biological parents, siblings or children) do not have current or past mental health conditions. You have also told us that you do not have any chronic health conditions. We invite you to take part to help us understand more about how things like social factors could offer new ways to support mental health beyond standard treatments.

• People living with severe mental illness can sometimes feel very lonely and may not have friends, family, or community around them for support. These friends, families and communities are what we call social networks. This study aims to understand more about how factors like being around these social networks might lead to meaningful improvements for people with severe mental illness. This study will also examine how social factors can affect key biological responses such as stress and inflammation, measured through blood and saliva samples, that may worsen outcomes of mental illness. We will use findings from this study to develop and test approaches that focus on social factors, such as connecting people to community activities, groups and clubs to improve health and wellbeing.
  
  

It is your choice to take part

You do not have to take part. Deciding not to take part or changing your mind about taking part will not affect the healthcare you receive, or your legal rights in any way. You can choose to skip any questions, pause, stop the study at any time without needing to give a reason.

What if you change your mind about taking part?

If you decide to take part today, you can change your mind at any time. If you decide to stop taking part, we will keep the data we have collected about you unless you tell us to delete and destroy your data. If you get to the end of the study and decide afterwards that you no longer want your data to be used in the study, you must tell us within one month. This is because we may start analysing your data one month after you meet with the study team.

If you would like to withdraw, please contact the research team on wiph-socialhealthhub@qmul.ac.uk saying that you would like to withdraw from the study and whether you would like us to keep or destroy the data we have about you up to that point.

• If you would like to take part, we will ask you to sign a consent form. This is a form that will ask if you agree to take part in the study and its related activities. If we are taking consent from you online or via phone call, we will send you a link to an electronic consent form via email to add your name, phone number and date to show you consent to take part in this study. We will also ask you to sign the form using your finger, a stylus or computer mouse. If you are unable to use or access the form, we will ask if you are happy for us to note down your name, phone number and date you are being consented, to show that you consent to take part.
• After providing your consent, we would like to collect information from you. With your permission, your GP will only be informed of your participation if there is a safeguarding concern, for example if you disclose a risk of harm to yourself or others during the study, or if there are concerns, around your blood sample results, such as high cholesterol. Please note we will not conduct tests on your blood samples until the end of the study which could be up to 2 and a half years after you provide the first sample.

Meet the researcher (study visit)

We will invite you to meet with a member of the local research team. The meeting is expected to take no longer than two hours and will take place at one of our university or NHS sites. At the study visit you will be asked questions about your health history, your mental health symptoms, and we will take blood and saliva samples and physical measurements.

Online survey

We will send you an online survey to complete. It will take about 30 minutes, and you can do it on your phone or computer. You will be asked about your quality of life, mental health symptoms and social connections. You can do the survey either before, during  or after the study visit.  We can assist you with the survey if you would like help, for example over the phone or at an in-person visit. If you chose to complete the survey after the study visit, we’ll ask you to do it in the next three days.  If needed, a researcher from the team will contact you by phone to remind you to complete the survey and can help you to do this over the phone.  

Meet the researcher (study visit)

Next, we will invite you to meet with a member of the local research team. The meeting is expected to take no longer than two hours and will take place at one of Queen Mary University of London sites. At the study visit you will be asked questions about your mental health symptoms, and about your personal social network, including the people, groups and places which are important to you.

Physical measurements

During the study visit we would like to measure your height, weight, waist circumference and hip circumference. We will provide you with a tape measure so you can take your own waist and hip circumference,  or if you require that we take your measurements there will be a second member of staff present as chaperone. If you already know your measurements and prefer not to have them taken at the study visit, then you can tell us what your measurements are. You can also choose not to provide your measurements.

Blood samples

We would like to collect a small blood sample (about 50-60 ml) using one needle. This will be collected by a person trained by the NHS to collect blood. If for any reason the first blood sample is unusable, you can provide another blood sample during the visit if you wish to do so. Providing and/or repeating the blood sample will be entirely your choice.

Saliva samples

We would also like you to provide a saliva sample during the study visit. You’ll be asked to spit into the tube. This usually takes 3–5 minutes. We’ll give you clear instructions to help you. Providing a saliva sample will be entirely your choice.

At-home saliva samples

We would like you to provide 3x at-home saliva samples. These need to be collected over the course of one day; right after waking up, 30 minutes later and then 60 minutes after waking. To collect these samples, you need to allow saliva to pool in your mouth, then gently drool into the tube . Once all three are done, you need to post them back to us the same day using the prepaid envelope we provide. If you agree, we’ll provide you with full instructions and the collection kit. We ask that you collect these samples within a week after your study visit.

Queen Mary University of London is the sponsor of this study. This study is being organised by the Social Health Hub at Queen Mary University of London. This research is part of a wider Mental Health Platform being funded by UK Research & Innovation (UKRI), which includes six research hubs across the UK focusing on better understanding severe mental health conditions www.mentalhealthplatform.ac.uk

We hope that the results from this study will help us to understand more about how to develop approaches to support people with severe mental illness, which take into account the roles that people, places and communities play in supporting mental health.

There are no major disadvantages to taking part. The study will take up some of your time.

Some of the questions we ask relate to mental health, difficult past experiences, and emotions, which may be upsetting. You can skip any question, pause, or stop at any time.

If you feel distressed, the researcher can offer support and refer you to appropriate services. If you become very distressed and are concerned about yours and others’ safety, we will encourage you to contact your GP, or if you feel unable to do so, the researcher will contact your GP your behalf with your permission.

If you need additional support with your mental health, several organisations including the Samaritans charity and SHOUT crisis text line provide free confidential listening support from trained volunteers. You can talk about anything that's troubling you, no matter how difficult.

To speak to a volunteer…

• Phone 116 123 free and available 24/7
• Text "SHOUT" to 85258 free and available 24/7

Find further advice on getting urgent help for mental health on the NHS website: nhs.uk/nhs-services/mental-health-services/where-to-get-urgent-help-for-mental-health

You can also contact your local crisis telephone line on 111.

Finally, you may experience some discomfort when we collect your blood samples, but samples will be taken by trained experts to minimise any discomfort. This process will feel the same as any other blood test. As with other blood tests, there is a slight risk of bruising from the needle.

We will need to use information from you and from your medical records for this research project. We will only use information that we need for the research study. This information will include your:

• Name
• Date of birth
• Contact information (phone number, email address, postcode)
• Sex and gender
• Ethnicity and migration status
• Mental health outcomes: quality of life, loneliness, functioning, depression, anxiety, stress
• Experience of adverse childhood events
• Education and employment status
• Living conditions
• Health data: smoking status, alcohol use, sleep quality, recent infection
• Biological samples (blood and saliva)
• Physical measurements (height, weight, hip and waist circumference)

People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

Queen Mary University of London (QMUL) is the sponsor of this research. QMUL are responsible for looking after your information. We will share your information related to this research project with the following types of organisations:

• The Trust Research Environment of our collaborator DATAMIND, who will store your data. DATAMIND are a hub for health research data relating to mental health, allowing approved researchers within the hub to securely access essential linked, de-identified health data.

We will keep all information about you safe and secure by:

• Working in compliance with the General Data Protection Regulation (GDPR) and the Data Protection Act 2018.
• De-identifying your data by replacing your name with your code number. This includes labelling your blood and saliva samples with your code number.
• Having an appropriate data sharing agreement in place to share data between organisations, if data is being shared with a third party. These data will be linked with your code number and not any of your personal identifiable information.
• Restricting of your personal information to core members of the Social Health Hub research team only.
• Only using your personal information to contact you for the 12-month duration of the study
• Keeping a key document that will link your code number to your real identity on our secure drive within password protected folders, with only the core members of the research team being able to access it and link your data to you.

International transfers

If your data is shared outside the UK, it will be with the following sorts of organisations:

• Trusted academic or commercial partners or service providers

We will make sure your data is protected. Anyone who accesses your data outside the UK must do what we tell them so that your data has a similar level of protection as it does under UK law. We will make sure your data is safe outside the UK by doing the following:

• Some of the countries your data will be shared with have an adequacy decision in place. This means that we know their laws offer a similar level of protection to data protection laws in the UK
• we use specific contracts approved for use in the UK which give personal data the same level of protection it has in the UK. For further details visit the Information Commissioner’s Office (ICO) website: https://ico.org.uk/for-organisations/uk-gdpr-guidance-and-resources/international-transfers/
• we do not allow those who access your data outside the UK to use it for anything other than what our written contract with them says
• we need other organisations to have appropriate security measures to protect your data which are consistent with the data security and confidentiality obligations we have. This includes having appropriate measures to protect your data against accidental loss and unauthorised access, use, changes or sharing
• we have procedures in place to deal with any suspected personal data breach. We will tell you and applicable regulators when there has been a breach of your personal data when this is legally required. For further details about UK breach reporting rules visit the Information Commissioner's Office (ICO) website: https://ico.org.uk/for-organisations/report-a-breach

Each de-identified sample tube will be sent to a laboratory for processing. This means that any personal information that could link the sample to you is removed and replaced with a unique code.

Some of these tubes will be used to analyse molecules in your blood to explore evidence of a biological link between social factors and mental health.

Other tubes will be stored and analysed in ongoing and future ethically approved research, including by the UKRI Mental Health Platform. Tests will be run on these blood samples which will help researchers to understand more about how treatment could be personalised to better meet the needs of individuals with severe mental illness.

Analysis of some tubes of blood may take place at centres within the UKRI Mental Health Platform network, or at external academic and commercial collaborators or service providers, in the UK or abroad. The UKRI Mental Health Platform may use this blood sample to measure a wide range of biological and genetic information, but this sample will be de-identified. Genetic analysis is not directly part of this study, but may be carried out in future, ethically approved studies by the UKRI Mental Health Platform network. As such, no information on potential DNA abnormalities can be made available to you in this study.

Some of your blood samples and data will also be shared with and analysed by researchers within the wider UKRI Mental Health Platform, and analyses may also be performed by commercial providers, but commercial test providers will not receive any of your personal information. These blood samples may be analysed by the Mental Health Platform network for a range of research purposes, including, but not limited to: 

• Extracting your genetic code from your DNA
• Analysing molecules to do with inflammation (the body’s immune response) and metabolism
• The results of tests done on these samples are for research only and not for diagnosis or medical care. Test results will not be given to your GP or treating clinical team unless there is a safety concern. The data and samples may be tested months or years after sample collection.
• The Mental Health Platform will store the blood samples and associated data for up to 20 years after the end of the study for possible use in future, ethically approved research. 
• If you wish to discuss any questions or concerns around the future use of your blood sample, please speak to a member of the research team.

Saliva is an easy way to get DNA for our genetic research and to measure stress hormones. Some of these de-identified sample tubes will be stored and analysed as part of ongoing and future ethically approved research. This could include research by the UKRI Mental Health Platform and external academic or commercial collaborators or service providers, in the UK or abroad. Your saliva samples will be stored and analysed following the same process used for blood samples.  If you wish to discuss any questions or concerns around the future use of your saliva samples, please speak to a member of the research team.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

We will keep your de-identified study data for a maximum of 20 years. The study data will then be fully anonymised and securely archived or destroyed. Biological samples (bloods and saliva) will be stored for a maximum of 20 years after the end of the study. After 20 years any left-over biological sample will be destroyed.

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.

You have the right to ask us to access, remove, change or delete data we hold about you for the purposes of the study. You can also object to our processing of your data. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this.

If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study. If you say yes, your data will be linked with other routinely collected datasets (such as the SAIL databank, national and regional health, social and education records and mental health records held by your NHS trust or health board in partnership with Akrivia Health).

If you share any information that suggests risk of harm to yourself or to others, or where you make any criminal disclosures, it will be necessary to break confidentiality. In these circumstances, the research team will need to share the information you provided with relevant the clinical teams, services and/or authorities.

You can find out more about how we use your information, including the specific ways we transfer your personal data by:

• Our leaflet [hra.nhs.uk/patientdataandresearch]
• Asking a member of the research team
• Sending an email to the study management team: wiph-socialhealthhub@qmul.ac.uk
• Contacting the data protection officer at QMUL: data-protection@qmul.ac.uk 

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect participants’ interests. This study has been reviewed and given a favourable opinion by HRA and Health and Care Research Wales Research Ethics Committee.

What should I do if I have concerns about this study?

Contact the research team if you have any concerns or any general questions about the study: Chief Investigator: Professor Jennifer Lau: wiph-socialhealthhub@qmul.ac.uk

If you have a complaint which you don’t want to discuss with the research team, then you should contact your local NHS Patient Advice and Liaison Service by e-mail: elft.pals@nhs.net 

Who you can contact if you have any questions about this study

• Talal AlMuzaini: CPPM-SHHTP@qmul.ac.uk 

Researchers’ names: Study co-ordinators: Dr Helen Buxton, Healthy volunteer co-ordinator:  Dr. Talal AlMuzaini, Chief Investigator: Prof. Jennifer Lau