Page 1: Information Sheet

Project Title: The Development of Contextual Cognitive Behavioural Approach to painful diabetic neuropathy; Revealing Patients’ Perceptions and Beliefs ​

We would like to invite you to participate in a study. This study seeks a more in-depth understanding of the patients’ experiences and perspectives related to painful diabetic neuropathy (PDN), in order to further develop an acceptable and effective psychological treatment for this condition. Before you decide whether to take part in this study, it is important that you understand why the research is being conducted and what is involved. Please take time to read the following information and feel free to ask if there is anything that is not clear or if you would like more information.

What is the purpose of this project?

This is part of a PhD project at King’s College London. It is hoped that this study will improve our understanding of Painful Diabetic Neuropathy (PDN). PDN is usually managed with medication. There has been little development or research into psychological treatments for neuropathic pain in general, including PDN. However, existing evidence demonstrates that psychological treatments applied to chronic pain, in general, are beneficial, in terms of improving functioning in daily activities for people who participate. In the current study, we assess the experience of pain from the perspective of people with PDN and examine their treatment needs and preferences.

Who is eligible to take part?

Participants will have to fulfil the following criteria in order to take part in the study:

  1. Confirmed diagnosis of diabetes.
  2. Presence of painful diabetic neuropathy, for the last three months or more.
  3. Aged at least 18 years.
  4. Willingness and ability to take part.

Why have I been invited?

You have been identified as a potential participant because you have a confirmed diagnosis of diabetes and you suffer from neuropathic pain due to diabetes.

What will I have to do if I agree to take part?

Participants will have to answer ten short questionnaires, which overall will help the research team to collect demographic data, and assess pain intensity, certain attitudes toward pain, mood, and the impact of pain on participants’ daily physical, social and work activities.

How much of my time will participation involve?

Participation should take no more than 45 minutes.

Will my participation in the project remain confidential?  

Yes. We will follow ethical and legal practice, and all information about you will be handled in confidence. The information you provide is completely confidential and anonymous. Your responses to the questionnaires will be used for this project only. The results from the analyses of the combined data will be summarized and submitted for publication in an academic journal and also be presented at scientific conferences. No participants’ identity will be included in these reports. KCL and GSTT, acting as sponsor and co-sponsor of this study, may also have access to the collected data for monitoring purposes. If data is transferred through optical media, it will be encrypted through password protection during transfer. When data are stored on University computers, password-controlled access to the secure network will be restricted to the research team members only. The collected data will be kept for a maximum of 5 years. Any identifiable information from questionnaires will be removed. An ID number will be assigned to each completed questionnaire to ensure that data cannot be traced back to an individual. Your anonymised data will be shared with other researchers and may be used for other research purposes. At the end of the present survey, you will be kindly asked if you like to take part to further research, if yes you will be asked to provide your contact details which will be stored from 6-12 months. Your contact details will only be used to help the research team get in touch with you for a future study. Nobody else will have access to your contact details.

What are the advantages of taking part?

You will have the opportunity to share your thoughts on diabetes and neuropathy. The results from this survey will provide valuable input and will help in the development of an acceptable and potentially effective psychological treatment for people who suffer from painful diabetic neuropathy.

Are there any disadvantages of taking part?

We do not foresee any disadvantages of participating in this study, except that it does require some time. 

Do I have to take part in the study?

No. It is entirely your decision as to whether you take part in this study. If you decide to take part, you will be asked to complete a consent form. Please note the deadline to request withdrawal of your data from the study will be four weeks after the end of data collection. It will not be possible to withdraw your data after analysis. If you wish you are free to withdraw at any time during the study period without giving a reason, even if you initially decided to take part.

What will happen to the results of the research study?

The study will be presented at scientific conferences and be written up for publication in scientific journals. We will provide you with a summary sheet of the results if you wish.

Who should I contact for further information?

If you have any questions or require more information about this study, please contact me using the following contact details: Name: Miss Kitty Kioskli (PhD candidate), Email: aikaterini.kioskli@kcl.ac.uk, Telephone: +44 (0) 2071880188 

 What if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions [Professor Lance M. McCracken, Email: lance.mccracken@kcl.ac.uk, Telephone: +44 (0) 207 188 5410, Health Psychology Section, Psychology Department, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), Guy’s Campus, London, SE1 9RT]. If you remain unhappy and wish to complain formally, you can do this through the Guy’s and St Thomas’ Patients Advice and Liaison Service (PALS) on +44 (0) 20 7188 8801, pals@gstt.nhs.uk. The PALS team are based at the main entrance on the ground floor at St Thomas’ Hospital and on the ground floor at Guy’s Hospital in the Tower Wing. If something does go wrong and you are harmed during the research you may have grounds for legal action for compensation against Guy’s and St Thomas’ NHS Foundation Trust and/or King’s College London, but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you (if appropriate).

Thank you for reading this information sheet and for considering taking part in this study.