Participant Information Sheet 

You are being invited to take part in a research study called ‘The Complex Emotions Research Study’. We want to learn more about what influences these emotions and how to improve support and treatments available.These complex emotions experienced may or may not be linked to diagnoses such as Borderline Personality Disorder (BPD), Emotional Unstable Personality Disorder (EUPD) and Complex Post Traumatic Stress Disorder (CPTSD). We understand that these terms can be stigmatising, so we have chosen to use the term complex emotions instead. The study is led by the University of Sheffield and the University of Plymouth. 

This study is being organised by Professor Scott Weich and the research is part of a wider Mental Health Research Platform funded by UK Research & Innovation (UKRI). The platform includes six research hubs across the UK, all focused on better understanding severe mental health conditions.

The study proposal has been reviewed by:

• An independent panel of experts at UKRI as part of the funding process.

• People with lived experience of mental health conditions, who have provided feedback on the study design and ethics as part of the Lived Experience Advisory Panel.

• An independent NHS Research Ethics Committee (insert REC name) that has given a XXX ethical opinion.

• NHS Management Approval has also been XXX

By complex emotions we mean experiences and feelings that can be confusing and difficult to manage, like difficulties in relationships and worries about being abandoned; difficulties regulating emotions, with strong emotions, but also episodes of detachment, or dissociation; negative self-views and/or managing impulses that might have negative consequences, including self-harm and suicidal feelings. 

These problems are often linked to diagnoses such as Borderline Personality Disorder (BPD), Emotionally Unstable Personality Disorder (EUPD) and Complex Post Traumatic Stress Disorder (CPTSD). However, this is not an exhaustive list of diagnoses and many people who have these experiences may have had other diagnoses such as Depression and Anxiety, Autism and Emotional Dysregulation, alongside a whole host of labels, and there may be other people who do not have any official diagnosis at all. 

We understand that these terms can be stigmatising, so we have chosen to use the term complex emotions instead. 

You have been invited to take part because you self identify as experiencing difficulties with complex emotions, and experience one or more of the following difficulties:

• Challenges in creating and maintaining relationships 

• Fears of abandonment

• Difficulties regulating emotions

• Experiencing intense emotions or feelings of detachment (dissociation)

• Managing impulses, such as self-harm or suicidal thoughts

• Sometimes people will use substances such as alcohol and drugs in order to numb these intense emotions

• You will be aged 16 years or over and living or working in Plymouth or Sheffield areas. 

• You do not need to have a formal diagnosis associated with complex emotions or be under specialist complex emotions health care services. 

• You do need to be able to be comfortable reading and speaking English to take part. 

You may have heard about this study in different ways. For example, you might have been approached by someone you know in a health or social care service, or through a staff member in a voluntary organisation. You might also have seen a poster or flyer in a place you attend, or heard about it directly from the research team or our website. 

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

Read below to find out a bit more about each stage of the research. 

1. Screening survey: You will be asked to complete an individual online screening survey that will take no more than 20 minutes to complete and will ask questions about your experiences with complex emotions and your personal details (e.g., age, gender, and contact information). This will help to confirm your eligibility and allow us to contact you. Your responses will be securely stored and not shared outside the research team.

2. Baseline Interview:  If eligible, you’ll be invited to an in-person or online interview lasting about 1 hour. We will go over the consent form, answer any questions, and discuss your experiences and symptoms in more detail. We will be using a diagnostic interview as a research tool to guide this baseline interview. It will be conducted by researchers for research purposes only. There will also be some online surveys we will ask you to complete, to help us you can do these during this interview or in your own time online afterwards.  You will receive a gift voucher as a thank-you for your time.

3. Surveys every 6 months: Over the next 3 years, you’ll be asked to complete a short survey every 6 months on your emotions, mental health, and physical health. These can be done online, via video call, or face-to-face. For each completed survey you will recieve a small gift voucher as a thank you.

4. Optional Sub-Studies: As part of this study we are also seeking permission from you to contact you about optional sub studies. For each sub study you will be individually contacted and sent information about what the sub study involves to help you make a decision if you would like to be a participant in that sub study. The optional sub-studies might include tasks such as being asked to take part in additional interviews to explore specific experiences, using digital tools (eg. smartphone apps and smartwatches) to record emotions and experiences in real time and co-designing and testing new support interventions. For each sub study there will also be a separate consent form which you will need to read and sign to take part.  Taking part in this main cohort study does not mean you have to take part in any of the sub studies.

You will have a named researcher to contact with any questions or concerns throughout the study.

As part of this research study, we will collect some identifiable information (e.g., your name, contact details, and relevant medical conditions). This is needed to stay in touch with you and to support our analysis. 

We will collect data on:

• Your basic demographics: Age, gender, ethnicity, housing, and employment.

• Your complex emotions: Symptoms and their impact on daily life. We will also ask about trauma experiences, self harm and suicidal thoughts.

• Your wider mental health: Including co-occurring challenges, medications, diagnoses and services you access

• Your physical health: To better understand its relationship with complex emotions.

• As part of the interviews will be collecting your stories of how this has impacted you and your life as well as your experiences of support and services.

All the information we collect during the course of the research will be kept confidential and there are strict laws which safeguard your privacy at every stage. During analysis, all personal details will be replaced with a unique number, and any published results will not include information that could identify you. If quotes from your interviews are used in the research, they will be anonymised. However, it is possible you may recognise your own words. If you tell us anything that puts you or someone else in danger/harm then we may have to break confidentiality, but we will let you know if this happens.

GP Notification: We will inform your GP that you are taking part in this study. However, no data collected during the study will be shared with them unless you request it.

We aim to be as paperless as possible, any identifiable information collected from you during this study will be stored securely on online servers managed by Sheffield and Plymouth University; (such as the University of Sheffield data storage service Xdrive). Access to this data will be limited to members of the research team who need to access it. 

Your data will be anonymised by assigning a code number instead of using your name for all analysis and publication purposes. Any personal information collected on paper will be kept secure in locked cabinets within locked offices at the University of Sheffield and University of Plymouth (ADD ADDRESSES). 

Collaborators on the research project may access your data, but any sharing with third parties will be covered by strict data sharing agreements to ensure your information is protected. Once the study is complete, we will retain some data to verify the results. It will be stored for 15 years after the study ends, after which it will be securely deleted. Reports and publications will not contain any information that could identify you.

You will be given the options on the consent form for your anonymised data (data that does not include any personal information such as your name, DOB, Address) to also be shared with:

• DATAMIND - This is one of the mental health research hubs also funded by the UKRI. They are developing a mental health data repository (this is a virtual place where anonymised data collected in different mental health research projects is stored and can be used in future by researchers or industry partners). Your anonymised data could be used in DATAMIND's (or industry partners') future research.

• Researchers in the wider UKRI Mental Health Platform for additional cross analysis. The Mental Health Platform will store data for up to 15 years after the study ends for use in future, ethically approved research.

• Additionally, analyses may be conducted by commercial providers, but no personal information will ever be shared with these providers.

The results of the research and the diagnostic tools used are for research purposes only and have not been validated for diagnosis or clinical care. This means they will not be shared with your GP or treating clinical team.

Results from this study will be shared as social media posts and reported to local and national news. We aim to publish the findings in scientific journal articles. We will also aim to present our findings  at scientific conferences as well as regularly updating our research study website with bulletins and newsletters of our progress and findings. You will not be identifiable in any published results. Participants will also be able to access the results through the study website.

No, taking part is entirely your choice.If you choose not to take part, or if you decide to withdraw at any stage, please contact one of the researchers involved in the study. However, you do not need to give a reason. Your decision will not affect your medical care or your legal rights in any way.

If you do decide to take part, you will be given this information sheet to keep and will be asked to sign a consent form. You will have lots of chances to ask questions, such as via email, phone or before any data collection such as at the start of any interview. 

You can withdraw from the study at any point without giving a reason. If you decide to withdraw from the study, you will have the option to: 

• Withdraw from all aspects of the study, but allow us to continue to analyse the data collected from you up to that point; or 

• Withdraw from all aspects of the study, and withdraw all of the data collected from you up to that point from any analysis. 

Once the study has ended, it will no longer be possible for you to withdraw your data. 

Unfortunately there might be a number of reasons why you can’t take part.

• If you live outside of the recruitment area or have no connection to the recruitment area - we are only funded to explore this research question in the Plymouth and Sheffield regions. 

• If you are unable to comfortably speak or read English.

• If you don't meet inclusion criteria of experiencing symptoms associated with difficulties with complex emotions. 

It might mean this is not the right study for you. 

If you are eligible to participate in the research study, we are offering vouchers to thank you for your time and engagement in the project.

You will be paid in ‘love to shop’ vouchers, these are not exchangeable for cash or alternatives but can be used in a wide range of retailers online and in store. We apologise for any inconvenience with this. We will also cover any travel costs that you require to attend any in-person aspects of the study, however travel is not an essential part of this research study. 

• For Screening interview you will be reimbursed with vouchers a sum of XX

• Each 6 monthly survey you will be reimbursed with vouchers a sum of XX  (There will be a maximum of 5 of these) 

This means that you will be reimbursed a total of up to XX for taking part in this study. There will be additional reimbursements of your time if you decide to take part in any sub studies.

We hope that the information you provide will help us to develop more effective approaches to clinical care and treatments in the future for people who experience complex emotions.

While it is unlikely that you will experience direct benefits from taking part in the study in terms of treatment or understanding your health, participating in research can be a positive and empowering experience. It provides a potential opportunity to share your experiences and tell your story in a meaningful way.

Additionally, the research team will send you regular newsletters and updates about the study. These will include information on what we are doing, key findings, and useful resources. These updates will be co-written with our Lived Experience Advisory Panel, a group of over 10 people with lived experience who are actively helping us design and review all our materials. The findings from this study could contribute to improving the care and support available to people with complex emotional challenges in the future.

There are some possible risks associated with taking part in this study, which are outlined below. Although every effort will be made to minimise or eliminate these risks, it is important that you understand them so you can make an informed decision about whether this is the right study and time for you to be involved.

If any of the following risks affect you, please remember that you can take a break, pause, or withdraw from the study at any time.

• 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.

• 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, take a break, 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.

• 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.

This is a research study and we are unable to offer therapy or treatment as part of our research study. However we do want to support you in being a research participant. During your baseline interview you will be told who your named contact will be whilst you are a participant; your named contact will be one of the members of the research team. They will contact you on your preferred method of contact (such as phone, text or email) to check in with you every 6 months and remind you when a data collect point is due or to invite you to sub studies. They will also be your main point of call if you have a question, query or comment about the research and the research process. They will only be contactable during office hours 9am - 5pm Monday - Friday - they will try and get back to you within two working days. This is not a crisis line. We can only signpost to other services available or to your health care team. During your initial interview we will ask for an emergency contact detail and your GP details, We would only contact these and emergency services  if a safeguarding issue was flagged with a threat to life (self or others).

If you find yourself becoming upset or distressed or share information , is there anything that we can do that will help you'? Telephone numbers for participants support network, signposting - a mini plan of action for each individual participant? 

If you have a question or concern about any aspect of this study, please contact the study team at: complex_emotions_hub@sheffield.ac.uk who will do their best to answer your questions. 

In the unlikely event that something goes 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 NHS [XXXX]  but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you (if appropriate).  

If you would like to discuss this study with someone independent of the study please contact <insert contact details>. 

If you wish to make a complaint about the study please contact: 

• Patient Experience Team 

• University of Sheffield/Plymouth contact details 

• SHSC

• PI - Scott Weich