Investigators: Associate Professor Simon Knowles (Principal Investigator and Clinical Psychologist), Dr Pragalathan Apputhurai (Lecturer in Statistics), Mr James Overs (Research assistant), and Associate Professor Jason Tye-Din (Consultant Gastroenterologist, Walter and Eliza Hall Institute of Medical Research).

Introduction to project:

We are looking for participants who are at least 18 years of age, diagnosed by a medical professional with coeliac disease, and have English as a first language or able to read English. It does not matter if you currently follow a gluten-free diet or not.

Research background

Existing research into coeliac disease indicates that individuals living with this condition experience a range of physical, psychological, and social challenges, which can impact on individual well-being and quality of life. A commonly reported experience of individuals living with coeliac disease is brain fog. Over the past few years, the Australian and New Zealand Coeliac community have very kindly provided their valuable to help develop the world’s first brain fog severity scale for Coeliac disease; to access the publication, go to HERE.

Now that we have a brain fog scale, we need your help to attain a large representative sample of responses from individuals who live with Coeliac disease. Importantly we seek responses from both individuals who do and do not experience brain fog to participate.

The purpose of this study is to gain knowledge about brain fog, and based on a large set of participant responses develop normative values on the brain fog severity scale. This study will also seek to explore the relationship between brain fog severity and gastrointestinal symptoms, cognitive functioning, chronic fatigue, psychological distress, and quality of life across two time points separated by one month. Your participation in this research will provide a significant contribution to the current knowledge relating to brain fog and help us to develop normative values relating to brain fog.

What will participation involve?

Participation will involve completing a 25-minute online questionnaire on TWO occasions. After the completing the study questionnaire on the first occasion, you will be invited to provide your email address. If willing, one month after completing the study questionnaire on the first occasion, you will be emailed and invited to complete the second study questionnaire by a unique participant link. Please note that your email address is confidential will not be linked to your responses. Your email address is only used by the questionnaire software in order to invite you to participate in the follow-up questionnaire and link the two time points. If you wish to receive the invitation, please be aware that you are also not obligated to participate in the second study; all participation is voluntary.

Consent:
Consent to use your responses now and in the future will be implied by completion of the online questionnaire. Please note that while you may choose to withdraw, any information you have provided will be recorded in the online Qualtrics questionnaire. All incomplete responses will be deleted prior to any primary statistical analyses being undertaken.

Participant rights and interests – Privacy & Confidentiality, Research outcomes:
Your responses will help to better our understanding of brain fog and its impact on individuals living with coeliac disease. Any information you provide will be anonymous and confidential. Strict confidentiality will be upheld to ensure that all participants cannot be identified in any material presented to any sources, including all journals if the findings of this research is selected for publication. All non-identifying data will be retained for an indefinite period or archived permanently on a password-protected Swinburne OneDrive network only accessible by the researchers for future use. The grouped and averaged results obtained will be presented in the form of a research publication. The findings of this research will also be made available through the Principal Investigator’s website (www.mindovergut.com) and through Coeliac Australia’s member communications. You are also welcome to email the Principal Investigator for a copy of the summary results.

Further information about the project – Who to contact: If you have any questions, please feel free to ask at any stage by contacting: Associate Professor Simon Knowles, Principal Investigator and Clinical Psychologist, Swinburne University of Technology, Hawthorn. Ph: + 61 03 9214 8206, email: sknowles@swin.edu.au

Participant rights and interests – Support:
As this study explore issues relating to gastrointestinal symptoms, cognitive functioning, mental health, chronic fatigue, quality of life and brain fog, please do not participate if you believe doing so may cause undue distress.

If you feel concerned about any of your answers to this questionnaire and how it relates to your physical and/or mental health or the wider community, please do not hesitate to contact the Principal Investigator (Associate Professor Simon Knowles, sknowles@swin.edu.au, ph: +61 03 9214 8206). Alternatively, if participating in the study has caused any concerns, you may want to consider contacting your local health professional. If you are experiencing a crisis and need help urgently, phone Lifeline on 13 11 14 (Australia) or Suicide Line on 1300 651 251 (Australia), or your local area emergency service.

Useful online services are also available at:
http://www.health.vic.gov.au/mentalhealthadvice/
http://www.befrienders.org/
http://www.beyondblue.org.au/

Coeliac Australia is a national registered charity dedicated to supporting Australians with coeliac disease and other conditions requiring a gluten-free diet. For information, support and other useful resources please visit: www.coeliac.org.au or call: 1300 458 836.


Concerns/complaints about the project – who to contact:

This project has been approved by or on behalf of Swinburne’s Human Research Ethics Committee (SUHREC) in line with the National Statement on Ethical Conduct in Human Research. If you have any concerns or complaints about the conduct of this project, you can contact: