PARTICIPANT INFORMATION SHEET

Worry in older people and how it affects them

Student researcher: Jessica Plumbridge (jessica.plumbridge@hmc.ox.ac.uk)

Principal investigator: Professor Paul Salkovskis (paul.salkovskis@hmc.ac.uk)

Introduction

We would like to invite you to take part in our research study. Before you decide, it is important that you understand why the research is being done and what it would involve for you. Please take time to read this information and discuss it with others if you wish. If there is anything that is not clear or if you would like more information, please ask us.

Brief summary

This research aims to investigate how worry can affect older people. Previous research has shown that research can have lots of different effects on people, and we are interested in looking at this more in this group. The study will look at how worry and mood is related to different impacts for older people and will think about how this might affect them day-to-day.

Participants will be asked to complete a series of questionnaires about topics such as your emotions and worries. This will be done as part of a one-off, in-person appointment with a researcher. You will complete the questionnaires only once.

What is the purpose of the study?

The study hopes to help our understanding of how worry can impact older people, and to help future thinking about how potential negative impacts might be reduced.

Why have I been invited to take part?

You have been invited to take part in this study because you are 65+ years old and have responded to advertisement for the study.

Do I have to take part?

No. It is up to you to decide whether to take part. If you do take part, you can withdraw from the study at any point, without giving a reason. Neither declining to take part not withdrawing will affect your legal rights. You can withdraw by contacting a member of the research team (details below).

What will happen if I decide to take part?

If, after reading this information sheet you agree to take part in this project, you will first be asked to complete a consent form to provide your informed consent to participate in the research.

You will then complete a series of questionnaires with the researcher. These questionnaires will be completed with a researcher from the team as a standalone in-person appointment. We estimate that the appointment will take no longer than 45 minutes.

Are there any possible disadvantages or risks from taking part?

The study will involve you being asked questions about your mental wellbeing and worry. These will include questions about any anxiety, low mood, and worries around health. It is possible you might find some of these questions distressing. You will have an opportunity to discuss this with a researcher if you wish to do so.

If you do have concerns about your health or wellbeing following the study, please see our leaflet: ‘Do you have questions or need help?’

What are the possible benefits of taking part?

There will be no direct personal benefit to you from taking part in this research. The wider benefits are that you will be contributing useful information to help our understanding of how worry can impact people. We do not know what the outcome will be, and this is why we are conducting the research.

Will my General Practitioner (GP) be informed of my participation?

No, your GP will not be informed of your participation.

Will my taking part in the study be kept confidential?

Yes. All study records and data will be identified only by a code. We will only use names or contact details where this is necessary to contact you. Information that can identify you will only be held if you choose to be contacted when the rests of the study are available. This information will be kept separate from the data. Your details will be separated from your data approximately 2 weeks after you have participated in the study, at which point the research team will no longer be able to identify your data from the data set.

Confidentiality will be maintained as far as it is possible, unless you tell us something which implies that you or someone you mention might be in significant danger of harm. In this case, we would have to inform the relevant agencies, but we would discuss it with you first.

Responsible members of the University of Oxford, regulatory authorities, and Northamptonshire Healthcare NHS Foundation Trust may be given access to data for monitoring and/or audit of the study to ensure that the research is complying with applicable regulations.

What will happen to my data?

Data protection legislation requires that we, the University of Oxford (whose legal name is The Chancellor Masters and Scholars of the University of Oxford), state the legal basis for processing information about you. In the case of research, this is a ‘task in the public interest’. The University of Oxford is the sponsor for this study and is responsible for looking after your information and using it properly.

We will need to use information from you for this research project. We will share your information related to this research project with the following types of organisations: health services (study clinicians only), university researchers (study researchers only).

This information will include your name (until data is anonymised), contact details (kept separate from your study data to contact you about the study results) and demographic information.

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.

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

• Keeping information recorded on paper locked securely until it is transferred to a secure electronic file, which will only be accessible to the research team.
• Your contact details will be kept separate from your study data and demographic information.

International transfers

Your personal 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 the minimum period of time required by the University of Oxford (5 years).

What are your choices about how your information is used?

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 remove, change or delete data we hold about you for the purposes of the study. 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.

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

• asking one of the research team: Jessica Plumbridge jessica.plumbridge@hmc.ox.ac.uk.
• sending an email to paul.salkovskis@hmc.ac.uk
• calling us on 07796 701290
• contacting the University’s Data Protection Officer data.protection@admin.ox.ac.uk
• looking at the University’s privacy notice available at: How we use your personal data for research purposes | Compliance.

If you would like to find out more about the use of confidential data in research, the HRA has developed a general information leaflet which is available at: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/templates/template-wording-for-generic-information-document/

If you request reimbursement for travel to the research appointment, payment will be made via bank transfer. As per University policy, bank details will be held for 7 years.

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

Please see section above titled: ‘Do I have to take part?’. Participation is voluntary: you can change your mind at any stage. However, after data has been anonymised, it will not be possible to remove your data from the dataset.

Will I be reimbursed for taking part?

To compensate for your time, you will be offered a £5 shopping voucher.

You will be reimbursed for bus or train tickets if you provide receipt evidence. Those who travel by car will be reimbursed at a rate of 30p per mile. Payment will be made via bank transfer.

What happens at the end of the study?

The findings from the study will be written up as part of Jessica Plumbridge’s Doctorate in Clinical Psychology thesis and will also be submitted for publication in an academic journal. It will not be possible to identify you from these outputs.

If you take part in this study, we will ask if you wish to be notified when results are available. If you chose to be notified, we will collect your email address (or postal address if email not available). This will be kept separately to the rest of the data (to maintain confidentiality). When results are available, a URL or printed results will be sent to the email/postal address. Contact details will be deleted when results have been sent to participants.

What if there is a problem?

If you have a concern about any aspect of this study, please speak with the research team (contact details at end of this document). They will do their best to answer your questions.

The investigators recognise the important contribution that volunteers make to medical research and will make every effort to ensure your safety and wellbeing. The University of Oxford, as the research sponsor, has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your taking part in this study. If something does go wrong, 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. While the Sponsor will cooperate with any claim, you may wish to seek independent legal advice to ensure that you are properly represented in pursuing any complaint.

If you wish to complain about any aspect of the way in which you have been approached or treated, or how your information is handled during the course of this study, contact Professor Paul Salkovskis (paul.salkovskis@hmc.ac.uk) or you may contact University of Oxford Research Governance, Ethics & Assurance (RGEA) at rgea.complaints@admin.ox.ac.uk.

How have patients and the public been involved in this study?

Service users have reviewed and commented on the study proposal. Service users and their carers have supported development of the project following the proposal.

Who is organising and funding the study?

The University of Oxford is funding and sponsoring the study.

Research team: Jessica Plumbridge (student researcher), Dr Louise Birkett-Swan (supervisor), Dr Canan Bektas (supervisor), Professor Paul Salkovskis (principal investigator).

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 participants’ interests. This study has been reviewed and given a favourable opinion by the Sputh West – Cornwall & Plymouth Research Ethics Committee.

Further information and contact details:

For further information of if you have a concern or query about any aspect of this study, please contact a member of the research team:

• • Jessica Plumbridge (jessica.plumbridge@hmc.ox.ac.uk)
  • Dr Louise Birkett-Swan (louise.birkett-swan@nhft.nhs.uk)
  • Dr Canan Bektas (canan.bektas@psy.ox.ac.uk)
  • Professor Paul Salkovskis (paul.salkovskis@hmc.ac.uk)

Thank you for reading this information.

PARTICIPANT INFORMATION SHEET

Study title: Understanding the link between autistic traits and eating behaviours in different situations

Central University Research Ethics Committee Reference: MS IDREC 719535

1. Introductory paragraph

You are being invited to take part in a research project. Before you decide whether to take part it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether you wish to take part.

2. Why is this research being conducted?

There is a known association between autism and eating disorders, such that autistic people may be more likely to develop an eating disorder. However, little is known about why this association is observed or whether there are certain factors which make autistic people more vulnerable to developing an eating disorder. The purpose of this study is to investigate the relationship between autism and eating behaviours. We aim to better understand how thinking, eating and other habits may be influenced by different situations in people with and without an autism diagnosis.

3. Why have I been invited to take part?

We are recruiting autistic participants and non-autistic controls to take part in this research. To take part, participants must meet the following criteria:

• Be aged 18 years or older
• Be fluent in English
• Not currently experiencing an eating disorder (ED) or Avoidant/Restrictive Food Intake Disorder (ARFID)
• Able to provide informed consent to participate

4. Do I have to take part?

No. It is up to you to decide whether to take part. You can withdraw yourself from the research, without giving a reason by advising the lead researcher of this decision.

The deadline by which you can withdraw any information you have contributed to the research is before the final questionnaire.  After this time, all data will be anonymised, so withdrawal of your data will not be possible. Prior to the final questionnaire you will be given more information about the study and will have the opportunity to withdraw if you wish to.  

5. What will happen to me if I take part in the research?

The following information gives an outline of what will happen if you take part in this research. If you agree to participate, you will be required to:

1. Fill in a screening questionnaire: We will assess your eligibility through a brief online questionnaire. If you are eligible, the lead researcher will be in touch to arrange a date and time for testing. Note: you may have already completed this part of testing.
2. Read this information sheet and sign the consent form: You will be required to sign the associated consent form and/or give verbal consent prior to taking part.
3. Complete pre-study questionnaires on the day of testing: If eligible, you will be asked to fill out several short surveys at different points on the day of testing which ask about things like your mood, height/weight, beliefs about yourself, and thoughts about food and eating behaviour.
4. Attend a 90-minute in-person session: On the pre-agreed day of testing, you will be asked to come in to the Department of Experimental Psychology for testing, which will take approximately 90 minutes. During this time you will be asked to complete a range of tasks which some people may find mildly stressful. This task is designed to help us understand how people respond differently to strange situations. Participants can ask to pause or stop the research activities at any time, unless otherwise stated.

With your consent, we would also like to video record parts of this call to allow us to interpret your answers to one of the tasks.

6. What are the possible disadvantages and risks in taking part?

Potential Risks:

•            Mild discomfort or stress arising from testing

Potential disadvantages:

• Participation requires time and effort.

7. Are there any benefits in taking part?

While there are no immediate benefits for those people participating in the research, it is hoped that this research will contribute to informing future understanding of and interventions for people experiencing (or at risk of developing) an eating disorder. 

8. Expenses and payments

There will be no payment for taking part in this research.

9. What information will be collected and why is the collection of this information relevant for achieving the research objectives?

Identifying information: The following identifying information will be collected at screening and kept securely in a password-protected Logbook with an associated participant number. The only people with access to this data will be the lead researcher and the Principal Investigator. This data will be deleted once you have completed the final questionnaire, or earlier upon your request:

- Your first and last name.

- Your email address (for arranging times for testing).

Further information: The following further information will also be collected and stored securely in a separate location to your identifying information. Your data will be identifiable only through your participant identification number. This information will help us establish that you meet the criteria for participation, determine which group you fit into, and allow us to determine to what extent our sample is balanced and representative.

-  Whether you do or do not have a diagnosis of autism (self-reported). There is no need for you to provide evidence of this diagnosis.

- Your score on the Autism Quotient (AQ). This will be used to validate your diagnosis.

- Your score on the Eating Disorder Examination Questionnaire (EDE-Q). This will be used to rule out an eating disorder.

- Your score on the Nine Item ARFID Scale (NIAS). This will be used to rule out Avoidant/Restrictive Food Intake Disorder (ARFID).

- Your gender.

- Your age.

- Your BMI; calculated by asking for your estimated height and weight.

Further data will also be collected throughout the course of the study relating to your mood, self-esteem, desire to eat, anxiety, endorsement of eating-disorder related behaviours, and endorsement of beliefs related to weight and shape.

Identifiable data (e.g. your name and email address) will be stored on the University of Oxford’s secure OneDrive in a password-protected folder. This will be deleted within 24 hours of completion of the study, or earlier upon request.

Anonymised research data and consent forms will be stored for 3 years in line with university regulations, after which time they will be destroyed.

10. Will the research be published? Could I be identified from any publications or other research outputs?

The findings from the research will be written up as part of the lead researcher’s thesis, and may be further submitted for publication in a journal and/or presented at a conference. Participants will not be identifiable from the written data.

A copy of my thesis/ dissertation will be deposited online in the Oxford University Research Archive where it will be publicly available to facilitate its use in future research.

Data Protection

The University of Oxford is the data controller with respect to your personal data, and as such will determine how your personal data is used in the research. The University will process your personal data for the purpose of the research outlined above. Research is a task that is performed in the public interest. Further information about your rights with respect to your personal data is available from the University’s Information Compliance website at https://compliance.admin.ox.ac.uk/individual-rights.

11. Who has reviewed this research?

This research has received favourable opinion from a subcommittee of the University of Oxford Central University Research Ethics Committee. (Ethics reference: xxxxx).

12. Who do I contact if I have a concern about the research or I wish to complain?

If you have a concern about any aspect of this research, please contact Daisy Burden (daisy.burden@stx.ox.ac.uk) or Myra Cooper (myra.cooper@psy.ox.ac.uk) and we will do our best to answer your query. We will acknowledge your concern within 10 working days and give you an indication of how it will be dealt with. If you remain unhappy or wish to make a formal complaint, please contact the Department of Experimental Psychology on 01865 271444, or the University of Oxford Research Governance, Ethics & Assurance (RGEA) team at rgea.complaints@admin.ox.ac.uk.

13. Further Information and Contact Details

If you would like to discuss the research with someone beforehand (or if you have questions afterwards), please contact:

Daisy Burden, Department of Experimental Psychology
University email: daisy.burden@stx.ox.ac.uk

Can you help us to understand clinicians’ perspectives of CBT treatment for anxiety?

(Central University Research Ethics Committee (CUREC) Approval Reference: R93179/RE001)

We are a team of researchers at the University of Oxford who are interested in better understanding clinicians’ perspectives of CBT treatment for anxiety. We are interested in hearing from people who provide CBT treatment for anxiety to adults. For this study, we are hoping to develop a deeper understanding of clinician factors that may contribute to outcomes of anxiety treatment with the hope of improving psychological treatments for individuals.

If you feel you can help us, or if you know someone who might be interested in supporting our research, please read the participant information sheet (below), and the poster (below) can also be distributed to anyone who may wish to take part.

The study involves completing a short task online which includes watching a short video and filling in an online questionnaire. It will take approximately 20-30 minutes to complete. You can start the study by clicking on this link: https://psychiatryoxford.qualtrics.com/jfe/form/SV_8Jp0HBmbSXP2JRs

If you have any questions or would like to participate, please email Nicola Roche at nicola.roche@psy.ox.ac.uk.

tdrp_information_sheet_1_curec_approved.docx

tdrp_information_sheet_1_curec_approved.docx

copy_of_tdrp_recruitment_correct_qr_16.07.pdf

copy_of_tdrp_recruitment_correct_qr_16.07.pdf