Information Sheet

A validation trial of Coeliac.Mindovergut.com: A brief psychological online resilience program for individuals living with coeliac disease and low-to-moderate psychological distress.

Principal investigator: Conducted by Dr Simon Knowles, Clinical Psychologist and Senior Lecturer, Swinburne University of Technology. Melbourne Australia.

What this project is about and why it is being undertaken?
Coeliac disease is a chronic gastrointestinal illness that affects around 1 in 70 Australians. Common symptoms include abdominal pain, bloating, diarrhoea, headache, fatigue, and weight loss. There is growing evidence for the interplay between the brain and the gastrointestinal tract, commonly referred to as the brain-gut axis. Reflecting this interaction between the brain and the gastrointestinal tract is the evidence that individuals living with coeliac disease commonly identify experiencing psychological distress, and that psychological distress is also known to exacerbate the physical symptoms of coeliac disease.

About Coeliac.Mindovergut.com resilience program for coeliac disease
Based on participant qualitative and quantitative feedback from the principal investigator’s previous online intervention programs (e.g. gastroparesisclinic.org) and recent evidence for the efficacy of transdiagnostic interventions (targets common processes that underpin most psychological disorders) a new coeliac-focused resilience intervention has been developed. The 5-module transdiagnostic intervention (with the 5th module being optional) has been designed to help facilitate resilience and promote optimal health in relation to living with coeliac disease. Although the Coeliac.Mindovergut.com resilience program for coeliac disease is designed to be completed within 4 weeks (Modules 1-4), you will have access to the program for up to 12 weeks, allowing you to participate at a pace that best suits you. The Coeliac.Mindovergut.com resilience program will help you identify and target stress, illness-related thoughts and beliefs, maladaptive illness-related coping patterns, all of which have been identified in the research as facilitating psychological distress and reducing quality of life. The Coeliac.Mindovergut.com resilience program is based on a combination of strategies developed from stress management, cognitive behaviour therapy, and acceptance and commitment therapy approaches.

Why is it being undertaken?
Now that I have developed the Coeliac.mindovergut.com resilience program, I am seeking your help to volunteer and complete the program and provide feedback from a consumer’s perspective. I aim to recruit a total of 89 participants.

Who can participate?
You are welcome to participate if you are (1) aged 18 or older, (2) have a diagnosis of coeliac disease by a medical professional (e.g. general practitioner, gastroenterologist), (3) experience low-to-moderate distress (as confirmed via the Mindovergut.com brief psychological distress assessment tool), and (4) not currently seeing a mental health professional (e.g. psychologist, psychiatrist) for mental health concerns.

What participation will involve – time, effort, resources, costs, compensatory payments, etc?
Both prior to starting the program and before accessing the optional 5th module, I will ask you to answer a questionnaire taking approximately 45 minutes to complete. The questionnaires will involve answering anonymous demographic questions and then completing questions relating to your gastrointestinal symptoms (e.g. How frequently do you experience abdominal pains, nausea and vomiting etc), gluten-free diet adherence (e.g. “I am able to follow a gluten free diet when dining outside my home"), illness perceptions (e.g. “How much does your illness affect your life?”), visceral sensitivity (e.g. “I’m always looking out for uncomfortable gut sensations"), pain catastrophizing (e.g. “I worry the pain in my gut will never get better”), thinking patterns (e.g. how much do you agree with the following statements: “You have a list of ironclad rules about how you and other people should act”), psychological well-being (e.g. “I found it hard to wind down”, “I found it difficult to relax”), personality (e.g. “I feel like I act totally on impulse”), and quality of life (e.g. “How would you rate your quality of life?”).

The questionnaires will also ask you to develop a unique ID (i.e. First 3 letters of your best friend’s surname and First 3 letters Mother’s maiden name) so I can match your pre- and post- Coeliac.Mindovergut.com resilience program results. In the final questionnaire (completed prior to the 5th module), I will also ask you to prove you feedback about the resilience program. In relation to the questionnaires, there are no right or wrong answers. I am are interested in your views and experiences, whatever they are. Consent will be implied by completion of the online questionnaires. Your feedback is essential so that I can continue to improve this free service.

In relation to the Coeliac.Mindovergut.com resilience program, each module (4 modules; with an optional 5th module) is designed to provide a step-by-step therapeutic program which aims to help you develop strategies to promote resilience and improve your ability to manage living with coeliac disease. Each module is designed to be completed over 1 week, however you will have access to the Coeliac.Mindovergut.com resilience program for a minimum of 12 weeks, to allow you to work at your own pace. Modules will include a combination of education about psychological distress as well as targeted behavioural and psychological strategies (e.g. identifying and challenging thoughts that contribute to your distress, relaxation-focused breathing), to help you develop strategies to facilitate resilience and promote optimal health in relation to living with coeliac disease. Access to the optional 5th module will be attained though completing a post-intervention questionnaire taking approximately 45 minutes. Your involvement in completing the post-intervention questionnaire is important as it will help me better understand how the intervention worked for you and how I can improve this free online service.

Each of the 4 core modules of the Coeliac.Mindovergut.com resilience program will take approximately 45 minutes to complete with additional homework activities taking around 20-40 minutes per day.

Participant rights and interests – Risks & Benefits/Contingencies/Back-up Support:
As this study explore issues relating to mental health, 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, please do not hesitate to contact the primary investigator supervisor (Dr. Simon Knowles, sknowles@swin.edu.au Tel: +61 03 9214 8206). Alternatively, if participating in the study has given rise to 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 131 114 or Suicide Line on 1300 651 251 (Australia), or your local area emergency service. If you are overseas, please search for local mental health services near you; one website that may be of help is http://www.befrienders.org/.

Participant rights and interests – Free Consent/Withdrawal from Participation:

Your participation is completely voluntary, and you are free to discontinue participation at any stage during the study without question. I respect your beliefs, customs and cultural heritage, and local laws. Given this, if you believe providing personal non-identifiable information (including about your physical and psychological well-well-being) and/or participating in the online resilience program may be inconsistent with your beliefs, customs and cultural heritage, and/or local laws I would recommend that you do not participate. If you have any questions or concerns relating to these matters, please feel free to contact the principal investigator.

Participant rights and interests – Privacy & Confidentiality:

At no point in the questionnaire is any information asked that can identify you as an individual. Information from all participants will be held in strict confidence to ensure that no participant can be identified from their responses. All of your provided answers will be stored anonymously with many other participant responses, and only the above researchers will have access to the data. All non-identifying data will be retained for at least 5 years post publication on a password-protected computer only accessible by the researchers. The grouped and averaged results obtained will be presented in the form of a research publication. The non-identified data may also be used in future research projects, including those being conducted by students. At the end of the pre-intervention questionnaire, you will be asked if you would like to provide contact details to take part in other research being conducted by the principal investigator. Any identifying information will be stored independently from the data provided in the pre-intervention questionnaire. This will ensure your responses and personal information will not be connected or able to be connected to your questionnaire responses.

Research output:

The research group conducting the study plan to write a report, which will be made available to anyone who is interested. The report will be available via Coeliac.Mindovergut.com. The results will also be written for publication in a scientific medical journal.

Further information about the project – Who to contact:
If you have any questions or feel any level of distress associated with this study, please feel free to ask at any stage by contacting the principal investigator: Dr. Simon Knowles, Swinburne University, Hawthorn (sknowles@swin.edu.au Tel: +61 03 9214 8206).

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:
Research Ethics Officer, Swinburne Research (H68),
Swinburne University of Technology, P O Box 218, HAWTHORN VIC 3122 Australia.
Tel (03) 9214 3845 or +61 3 9214 3845 or resethics@swin.edu.au

Consent

I have read, or have had read to me in a language that I understand, this document and I understand the purposes, procedures and risks of this research project as described within it.

I have had an opportunity to ask questions and I am satisfied with the answers I have received.

I freely agree to participate in this research project as described.

I understand that I can print off or contact the primary investigator to attain a copy of the information and consent form.

If you have read and agree to participate, please click on the button below.