Participant Information Sheet

Names of Researchers: Dr Lin Yu (Middlesex University), Dr Kitty Kioskli (University of Essex; trustilio B.V.), Dr Miznah Al-Abbade (University of Portsmouth), Prof Lance M. McCracken (Uppsala University)
Date: 14/01/2025
SECTION 1
1. Invitation paragraph
You are invited to take part in a research study. Before you decide 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. Please ask if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

Thank you for reading this.

2. What is the purpose of the study?
Living with chronic pain can be distressing and challenging. Unfortunately, medications do not always control pain. Psychological interventions can help some people to reduce the problems created by pain. Specifically, a form of psychological intervention, called ACT, has been applied to the management of chronic pain and has been shown to be beneficial for people with chronic pain. Although ACT may be helpful for some people, not everyone will benefit from this. At present, it is difficult to predict who will benefit from ACT, how ACT takes effect for them.

The purpose of the study is to find out how individuals with chronic pain respond differently to an Internet-based ACT, and how this comes about.

3. Why have I been chosen?
We are hoping to recruit 5-8 participants, and you may have indicated that you are interested in taking part in this study. You have been invited because you are aged 18 years or over, and have had persistent or recurrent pain for at least 3 months, and you have access to a smart phone.

People who are unable to participate due to (a) limits in communicating in English, (b) diagnosed severe psychiatric disorders that is currently poorly managed and has a significant impact on day-to-day life (c) significant cognitive impairment, and/or (d) reporting serious underlying malignancies such as cancer, and/or (e) receiving another form of regular psychotherapy, will not be invited to participate.

4. Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be emailed this information sheet to keep, and be asked to sign a consent form electronically. If you decide to take part you are still free to withdraw at any time and without giving a reason. If you do decide to withdraw from the study then please inform the researcher as soon as possible, and they will facilitate your withdrawal. If, for any reason, you wish to withdraw your data please contact the researcher within a month of the end of your participation. After this date, it may not be possible to withdraw your individual data as the results may have already been published. However, as all data are anonymised, your individual data will not be identifiable in any way.
5. What will I have to do?
Your participation will be entirely online.

You will receive an Internet-based psychological intervention for chronic pain over 5 weeks, with the support of a clinical health psychologist. When you receive the intervention, you will be asked to do the following:

- Participate in 8 online intervention modules over 5 weeks. The durations of the modules vary. The modules will require approximately 30 to 120 minutes of your time per week, depending on the modules you are assigned to complete in the week.
- The modules will consist of audio recordings and worksheets, and you will be guided through psychological exercises to develop better skills for managing pain and working toward your goals, and give you guidance for practice between sessions.
- A psychologist will check in with you via email or telephone every 1-2 weeks to support you in completing the modules, and help tracking your progress.

Additionally, your participation will involve:
- Completing online questionnaires about your pain, mood and functioning before the start of the intervention, immediately after the intervention, and then again 6 months after that. These questionnaires will take about 20 minutes to complete each time.
- Completing a set of very brief diary (daily) questions via an app, about your pain, mood, functioning, and some psychological processes, before the start of the intervention (for 7-21 consecutive days), during the intervention (5 weeks), and then again 6 months after that (for 7 consecutive days). These questions will take a few minutes to complete each time.

Your participation in the study will last about 8 months.

Please note that in order to ensure quality assurance and equity this project may be selected for audit by a designated member of the committee. This means that the designated member can request to see signed consent forms. However, if this is the case your signed consent form will only be accessed by the designated auditor or member of the audit team.
6. Will I have to provide any bodily samples (i.e. blood/saliva/urine)?
No.

7. What are the possible disadvantages and risks of taking part?
We do not expect that the study procedures will have a negative impact on your safety or wellbeing. There will be a time burden for completing the intervention and the questionnaires.

You may find some of the questionnaires or intervention materials upsetting. You can choose not to answer certain questions or questionnaires or not to complete intervention modules if you wish not to. You may contact the study team at any point of time during your participation if you are concerned about any distress you may have as a result of completing the study procedures. In addition, you may:

• Call 111 for Counselling & Mental Health support
• Contact Samaritans for support for emotional distress on 116 123, or at jo@samaritans.org
• Contact Anxiety UK for anxiety condition on 03444 775 774, or at www.anxietyuk.org.uk
• Find counselling service at https://www.nhs.uk/conditions/counselling/
• Contact your GP for help with pain
• Find other resources for help for pain at https://www.nhs.uk/live-well/healthy-body/how-to-get-nhs-help-for-your-pain/

Appropriate risk assessments for all procedures have been conducted and will be followed throughout the duration of the study.

8. What are the possible benefits of taking part?
We hope that participating in the study will help you. However, this cannot be guaranteed. Not everyone that receives ACT benefits from it, and we cannot guarantee you will experience any direct benefits of the intervention being studied here. However, the information we get from this study may help us improving treatments for people with chronic pain in the future.

9. Data Protection and Confidentiality
Personal data is any data that can lead to the identification of a specific (living) person. It can be obviously identifiable data such as name or ID number but it can also be a combination of "innocent" data such as age, height/weight, wealth, job position, company, city, etc. that when combined can lead to the identification of a person. Processing of personal data is any activity that is carried out with personal data (including collecting, analysing, recoding, etc).

Personal data (e.g., your name, email address, or any data that can identify you) WILL BE processed by this study and your confidentiality will be protected. All information you provide will be processed in accordance with the UK Data Protection Act 2018. Please click on the link below to view/download the Middlesex Privacy Notice for Research Participants:
https://www.mdx.ac.uk/about-us/policies/privacy/privacy-notice-for-research-participants

10. What will happen to the results of the research study?
The results of the research study will be summarized and submitted to academic journals for publication. The results may also be presented at conferences. However, the data will only be used by members of the research team and at no point will your personal information or data be revealed.

11. Who has reviewed the study?
The study has received full ethical clearance from the Research ethics committee who reviewed the study. The committee is the Middlesex University Research Ethics Committee (REC) – Psychology.

12. Contact for further information

If you have any questions or would like to participate in the study, please contact:

Dr Kitty Kioskli
kitty.kioskli@trustilio.com