Participant Information Sheet 

You are being invited to take part in a research project because you identify as someone who experiences (or struggles with) complex emotions. Before you decide whether to participate, it is important for you to understand why the research is being done and what it will involve. This document is a detailed participant information sheet, its purpose is to clearly explain more about the study, so you can decide if you want to be involved.  Thank you for reading this, please ask us if there is anything that is not clear in this document, or if you would like more information. Please be aware that you may find some of its content triggering.  

By complex emotions we mean feelings that can be overwhelming, unpredictable, or hard to control. Some people describe feeling too much or sometimes nothing at all. These can be hard to manage, and often centre around difficulties with relationships, emotional regulation, impulsive and harmful behaviour.

These problems are often linked to diagnosis such as Borderline Personality Disorder (BPD), Emotionally Unstable Personality Disorder (EUPD), Complex Post Traumatic Stress Disorder (CPTSD); as well as other diagnoses such as Depression and Anxiety, Autism, and Emotional Dysregulation. Some people who experience complex emotions may have one or more of these diagnoses; others will have no official diagnosis at all. Our research is not limited by diagnosis; we understand that labels can be stigmatising and limiting, so we have chosen to use the term complex emotions instead. 

This three-year study aims to better understand people who experience complex emotions, with a view to improving treatment, support, and outcomes for those who struggle with them. We want to learn more about what influences complex emotions and how they change over time.

We plan to recruit a diverse group of up to 300 people who experience a range of difficulties with complex emotions. We want to include people both with and without any related diagnosis and those who are currently receiving/previously received/ have never received support for complex emotions.

Information will be collected via surveys and interviews over the three years. We want to use the data we collect to help shape the care people receive, and to develop new interventions. Participants will also have the opportunity to take part in optional sub-studies, such as in-depth interviews, and the collection of real-time data using apps and smart watches (see Figure 1) but this is not a requirement. The research has been funded by UKRI, as one of six research hubs across the UK, all focused on better understanding severe mental health conditions. 

You have been asked to take part because you are 16 or older; you have lived or worked in areas designated within Plymouth or Sheffield postcodes, within the past 5 years (note that if a participant moves outside of this area during the course of the research they will be eligible to continue to take part); and you have one or more of the following difficulties with complex emotions:

●       Challenges in creating and maintaining relationships

●       Fears of abandonment

●       Difficulties regulating emotions

●       Intense emotions or feelings of detachment/dissociation

●       Difficulties managing impulses, such as self-harm or suicidal thoughts

●       Using substances like alcohol and drugs to numb these emotions

We are looking to recruit a mixed group of participants, including those who are often missed from complex emotions research, such as men, older adults, and people from ethnically diverse groups.

Please note, you do not need to have a formal diagnosis associated with complex emotions or be under specialist care to take part. However, participants must be comfortable reading and speaking English. 

If you decide to take part, you will be given this information sheet to keep  and you will be asked to complete a screening survey. You might get given this as a paper copy by someone in an organisation you use with a pre-paid envelope to post it back or you might get given a QR code to scan or a hyperlink which will take you to an electronic screening survey. We have built in lots of ways to ask questions before and during the research project such as a dedicated email.

●   Screening Survey: 20 minutes | online

You will be asked about your complex emotions and for some basic personal information (like your age, gender and contact details). This will clarify whether you are eligible to take part in our study and allow us to contact you.  This information is used for screening, not research purposes.

 Baseline Interview and baseline measures

60 minutes + | in-person or online video call (camera must be switched on for this)

If you are eligible to take part in the study then one of our researchers will contact you with more information and consent forms which you will need to have time to consider and sign (if you are happy to)  before taking part in the baseline interview. The Interview will be with one of our researchers. This interview is using a diagnostic interview tool for research purposes only, it will not give you any diagnosis. It helps the research team get to know you and how your complex emotions impact you.

This stage also includes a set of self report questionnaires, these will look at very specific symptoms and areas we are interested in exploring. You can complete these during or after the interview.  We will thank you for your time by sending you a gift voucher worth £30.

●   Repeat Surveys

45 minutes | every six months | online or via video call

These surveys will be sent to you every six months via an online survey or telephone/video call if you prefer. They will ask about your complex emotions, mental and physical health and social environment. We will thank you for your time by sending you a gift voucher worth £10 for each returned survey. Depending on when people join  this study the maximum number of repeat surveys you will be sent, would be five.

●   Optional Sub-Studies

We are also asking permission to contact you about additional studies linked to this one. These could be:

○        Interviews exploring specific experiences;

○        Using smartphones/watches to record emotions and experiences in real time;

○        Co-designing and testing support interventions for example.

We will send you information about what each study involves so you can decide if you want to take part, and there will be separate consent forms for each of them. Taking part in the main study does not mean you have to participate in any of the sub-studies. 

The research is planned to last for three years.

No, but, if you are screened as being eligible for the study, we are offering vouchers to thank you for your time and engagement with the project. These can be spent with a wide range of retailers online and in-store (note they cannot be exchanged for cash or alternatives). We will also cover any local travel expenses (although in-person attendance is not an essential part of the study).

• Baseline Interview and baseline measures = £30 voucher

• Repeat Surveys (up to a maximum of five)=  £10 voucher each survey completed

• In-depth interviews = £25 voucher 

• Optional Sub-Studies = This will be specified in the details and information provided by each sub-study

Whilst there may be no immediate benefits for those people participating in the project, it is hoped that this research will:

●   Empower you by knowing you are making a difference by helping towards improved future care, treatment, and outcomes for people who experience complex emotions.

●   Give you the opportunity to be heard and empowered by sharing your story.

●   Keep you informed (by receiving regular newsletters and updates) about the study and by having access to useful resources.

●   You will be thanked for your participation via vouchers.

 You will have opportunities to get involved in other related studies. 

Unfortunately, you will not be able to participate in the study if you:

●   Live or work outside Plymouth or Sheffield, or have no connection with these areas

●   Cannot understand or speak English comfortably*

●   Do not meet the eligibility criteria

 *We recognise this limits our ability to be fully inclusive, but some of our research tools have not been translated/tested in a wide range of languages.

You are under no obligation to take part in the study, it’s your choice.  If you do decide to take part, you will be given this information sheet to keep (and be asked to sign a consent form). Please note that by choosing to participate in this research, this will not create a legally binding agreement, nor is it intended to create an employment relationship between you and the University of Sheffield/University of Plymouth. You can take a break, pause, or withdraw at any time by contacting one of our researchers. You do not need to give a reason for your decision and your medical care or legal rights will not be affected in any way.

If you leave the study, you can either allow us to continue analysing the data we have collected from you or choose to withdraw it. Please note, once the study has ended, it will no longer be possible to withdraw your data. 

There are some possible disadvantages you need to be aware of. We have listed some of them below, along with the measures we will have in place to reduce this risk.

• Long time frame: This study spans approx 3 years, which may feel like a significant commitment. You will have the flexibility to take breaks if needed.

• Sensitive/Triggering questions: Many of the surveys and interview topics used in this study will ask about sensitive topics, including trauma, self-harm and suicide, which may be triggering. We fully appreciate the role that trauma can play in complex emotions and with this in mind we will only ask you to respond to questions you feel comfortable with. At any point during your survey or interview(s), you can pause and take a break, end the survey/interview or withdraw from the study. You can bring someone to support you to the interviews.

• Stigma: We recognise that complex emotions are not limited to specific medical diagnoses. However, for some participants, these associated diagnoses (e.g. BPD, CPTSD, or EUPD) may carry negative stigma. Please be assured that the information you share with us and your involvement in this study will remain confidential. All data will be securely stored on encrypted university servers, and any published results will be anonymised to ensure your privacy.

• Disappointment/Not being selected for sub-studies: Some of our sub-studies have limits on the number of participants, such as 40 for the interview sub-study and 50 for the smartwatch sub-study. Unfortunately, we cannot change these caps, which means not everyone who expresses an interest in a sub-study will be selected. We understand that this may be disappointing, and we want to emphasise how much we value and appreciate your interest and involvement. We will communicate selection decisions in a timely and sensitive manner. Details about selection criteria will be provided in the participant information sheets for each sub-study.

It is important to note that while we assure complete confidentiality, this may have to be broken if a participant appears to be at serious risk of harm to themselves or other people.

We cannot offer therapy or treatment but will do our best to support participants during the study by:

●      Providing a named contact for any queries, check-ins every six months, reminders and sub-study invitations (available 9am to 5pm, Monday to Friday only)

●      Signposting to relevant support/crisis/healthcare services

●  Having robust safeguarding measures in place, so we can direct you to the best place to support you and keep you safe

Please note, we will ask for an emergency contact and your GP’s details in case there is a risk of harm to yourself or others during the study. The emergency services may be called if there is an immediate threat to life. 

All the information that we collect about you during the course of the research will be kept strictly confidential, and any identifiable data will only be accessible to members of the research team who need to access it (for contacting you or transcription/anonymisation). When the anonymised data is being analysed you will be given a unique identification number to ensure anonymisation. You will not be able to be identified in any reports or publications. If you agree to us sharing the information you provide with other researchers (e.g. by making it available in a data archive) then your personal details will not be included unless you explicitly request this.

Confidentiality:

●       Adhering to strict UK safeguarding and privacy laws

●       Replacing personal details with a unique number during analysis

●       Keeping all published results anonymous so you cannot be identified

GP notification: If you agree we will inform your GP that you are taking part in this study. However, no data collected will be shared with them unless you request it.

Please note: If you tell us anything that puts you or someone else in danger, we may have to break confidentiality. We will let you know if this happens, and we will have a clear guidance in place that we will be adhering to. 

We will need to use information from you for this research project. This information will include:

●       Name and contact details.

●       Age, gender, ethnicity, housing, and employment status.

●       Survey and interview data including: your symptoms, behaviours and experiences related to complex emotions and their impact on your daily life, your social and cultural environment, traumatic experiences, self-harm and suicidal thoughts. Please note, results and diagnostic tools are for research purposes only, and have not been approved for diagnosis or clinical care. This means results will not be shared with your GP or other clinical practitioners.

●       Survey data about your wider mental and physical health and service use (including co-occurring challenges, medications, diagnoses and health related services and groups you access).

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.

Sheffield Health and Social Care NHS Foundation Trust is the sponsor of this research and are responsible for looking after your information. We will share your information related to this research project with the following types of organisations:

• Named university partners such as the University of Sheffield and University of Plymouth.

• A Data repository (anonymised data only) for long term storage and future research use.

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

Identifiable data (data with your name or contact details)

●       All Identifiable data will be processed (that means collected, stored and handled) at the University of Sheffield in their secure drives, with a small number of members from the research team. Only they can access it, so they can contact you to let you know about the research, send you a survey or invite you to a sub-study.

●       Any digital data will be stored on secure online servers managed by Sheffield and Plymouth Universities - these are called safe drives.

●       Survey data will be collected mainly online through secure programmes and stored on the University of Sheffield safe drive.

●       Interviews may be recorded on encrypted recording devices or recorded using online software such as Google Meet or Microsoft Teams. These will be also transferred to the University of Sheffield safe drive for transcribing, anonymisation and safe storage.

●       Any paper-based data (such as a signed consent form or handwritten postal survey) will be stored in locked cabinets and offices at Sheffield Centre for Health and Related Research, School of Medicine and Population Health, Regent Court, 30 Regent Street, Sheffield.

●       Where possible, hard copies will be scanned and uploaded to secure online servers, and then destroyed.

●       People who are going to be processing the data include transcribers (who will anonymise the interview recordings into transcripts) and project admin staff who will input the survey data into programmes for analysis. We typically use employees of the University of Sheffield or University of Plymouth for these services, where not possible we have external organisations where strict confidentiality agreements are in place.

Anonymised data (no identifiable information)

●       Due to the nature of this research, it is very likely that other researchers may find the data collected to be useful in answering future research questions. This will involve the anonymised data being stored in a data storage outside of the University of Sheffield. These third-party collaborators** are also bound by strict data sharing agreements. On the consent form there is an option for you to give explicit consent for your data to be shared in this way. You can opt out and still be part of this research

●   Once the study is complete, we will retain the anonymised data (transcripts and surveys) to verify the results. It will be stored for 15 years after the study ends, after which it will be deleted securely.

** In addition, you will be asked if your anonymous data can be shared with(this is optional):

●       Researchers in the wider UKRI Mental Health Platform - for additional cross analysis/use in future, ethically approved research.

●       DATAMIND - a mental health research hub (also funded by UKRI)/repository (this is an online databank of anonymised health related research data from lots of different research projects).  If you consent, your anonymised data could be used in future research or by industry partners (such as private or healthcare well-being businesses or app designers).

• Your data will not be shared outside the UK. 

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 study data for a maximum of 15 of years. The study data will then be fully anonymised and securely archived or destroyed.

●   Anonymised findings will be shared with participants on the study website, in regular bulletins and newsletters.

●   The results will be communicated more widely via social media, local/national news, scientific journals and conferences.

You will not be identifiable in any published results. 

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.

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 – you will be asked about this as an optional part of the consent form.  DATAMIND TRES is a mental health research hub (also funded by UKRI) and is a repository for storing research data. This is an online databank of anonymised health related research data from lots of different research projects, many looking at different areas of mental health.  If you consent, your anonymised data could be stored in this repository and used in future research or by industry partners (such as private or healthcare well-being businesses or app designers). 

You can find out more about how we use your information:

• By checking our project website www.complexemotionshub.co.uk

• By asking one of the research team

• By sending an email to complex_emotions_hub@sheffield.ac.uk, or by ringing us on [phone number].

• You can contact the sponsor. The sponsor for this study is Sheffield Health and Social Care NHS Foundation Trust, they are the organisation that takes on overall responsibility for proportionate, effective arrangements being in place, to set up, run and report this research project.  Contact Michelle Horspool email rdu@shsc.nhs.uk

Find out more about health research data at the Health Research Authority website www.hra.nhs.uk/patientdataandresearch  

Who has reviewed this study?

The study has been reviewed and approved by:

• An independent panel of experts at UKRI

• A Lived Experience Advisory Panel

• An independent NHS Research Ethics Committee Derby Rec / IRAS number 353789

We welcome questions and comments! 

If you have any questions about any aspect of this study, please contact the research team, Sally Ohlsen or Elissa Thompson: complex_emotions_hub@sheffield.ac.uk

Or write to us via: Complex Emotions Hub Team, Sheffield Centre for Health and Related Research,

School of Medicine and Population Health, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA.

• If you are dissatisfied with any aspect of the research and wish to make a complaint, please contact Professor Scott Weich, the chief investigator via s.weich@sheffield.ac.uk in the first instance.

• If you feel your complaint has not been handled in a satisfactory way and would like to contact someone independent of the research team you can contact the University’s Research Ethics and Integrity Manager, Lindsay Unwin: l.v.unwin@sheffield.ac.uk

• If the complaint relates to how your personal data has been handled, you can find information about how to raise a complaint in the University’s Privacy Notice: https://www.sheffield.ac.uk/govern/data-protection/privacy/general