Plain Language Information Statement
Plain Language Information Statement
A randomised controlled trial and consumer characteristics of iMindTime: A comprehensive mindfulness and loving kindness meditation wellbeing digital health program.
Professor Britt Klein: DVC-R Portfolio
Brooke Andrews: School of Health Sciences & Psychology; Owen Cole: DVC-R Portfolio; Dr Cameron Foale: Faculty of Science & Technology; Asher Leslie & Lewis Lakerink: Technical Consultants to project.
Thank-you for your interest in the iMindTime digital health program study. We invite people who are aged 18 years and over, who have access to the internet, to participate.
What is the project about?
This project seeks to determine the benefits of the comprehensive, yet brief, mindfulness-based iMindTime program designed to improve wellbeing and decrease stress. This program was developed using evidence-based techniques and it is designed to help people better deal with everyday situations and to enhance their mental and physical wellbeing.
The results from this project will be used by the researchers in the development of future health and wellbeing programs that will be made available to the general public.
What does this project involve?
The project involves collecting various pieces of information from you and your usage of the iMindTime program.
Participants will be asked to:
- Create a ‘My Digital Health’ platform (the iMindTime digital health program is one program amongst others that are housed within the ‘My Digital Health’ platform) account if you do not currently have one. This will involve providing an email address, username and strong password. Once you have completed this, you will receive a confirmation email that you will need to verify before you can proceed any further. If you would like to remain anonymous, we suggest you use an email address that does not contain your first and last name.
- Once you have created a My Digital Health account, you can then re-enter the platform and sign up specifically for the iMindTime program. Here you will need to agree to participate in the iMindTime study after reading through this Plain Language Information Statement and by clicking the “I agree to the above conditions” buttons below.
- Complete the pre-program questionnaires via this website. The questionnaires will ask you questions about yourself, including demographic details (e.g., age) and questionnaires asking you about your mental health and wellbeing (e.g., how optimistic you are, how stressed you feel, the strategies that you use to deal with emotional and stressful situations, time perception). The pre-program questionnaires should take approximately 25 minutes to complete.
- Consent to be randomly allocated to either the immediate access or delayed access (delayed by 7 weeks) to the iMindTime program groups.
- Immediate Access. You will receive immediate access to the brief iMindTime program. The program consists of 6 mindfulness sessions; each session will take about 5 minutes to read and 10 minutes of activities (e.g., guided mindfulness based audios)
- Delayed Access. If you are randomly assigned to the delayed access condition you will be asked to complete all the same online questionnaires, but will have to wait until the 1 month follow-up (start of Week 8) to access the program.
- Complete a daily mood and lifestyle web or mobile survey (e.g., average anxiety rating) (should take about 30 seconds) so you can monitor your progress graphically through your program dashboard. If you have a FitBit device, you are also able to integrate it to the iMindTime program to record your sleep, heart rate and number of steps per day.
- Complete two questionnaires (e.g., how optimistic you are feeling) in Week 2. This should take 3-5 minutes to complete.
- Complete the post program questionnaires in Week 4, again asking you about your mental health and wellbeing. However for those in the immediate access group, we will also ask you about your satisfaction with the mindfulness-based iMindTime program. This should take you about 25 minutes to complete.
- Complete the 1 month follow-up questionnaires at Week 8, which also ask you about your mental health and wellbeing. Once completed, the delayed access group will then be able to access the iMindTime program and will be asked to complete the post post questionnaires in Week 11, again asking you about your mental health and wellbeing and satisfaction with the iMindTime program. These questionnaires should take you about 20 minutes to complete.
The brief iMindTime program will record your usage of the program (e.g., how many times you logged in, the amount of time spent using the program). This information will not affect your use of the program. You will also be sent automated reminder emails during your 11 (delayed start group) and 8 (immediate start group) weeks while being involved in this study. You will be able to continue to access the iMindTime eHealth program for another 12 weeks following your 1 month follow-up assessment.
Can I withdraw from the project?
Participation in this project is completely voluntary. If you decide you do not want to continue with the project, you can withdraw at any stage of the intervention and follow up, without having to provide any explanation. Your withdrawal will have no impact on current or future relationships with Federation University.
What will happen to my results?
All information will be strictly confidential, subject to legal limitations, and stored securely using the ‘My Digital Health’ platform and linked survey management tool utilising the platforms 256-bit encryption SSL security certificate and can only be accessed by the investigators. When analysing any data, any identifying information will be completely removed and therefore cannot be linked back to you in any way. Your de-identified data may be used for research projects into the future. All data will be stored securely for five years after any publications. After this time the data will be destroyed. Any publications or thesis produced arising from the results from this study will only use aggregate or group data sets. As the data are analysed without any identifiable information, and as publications will report findings based on group data, individual participants will not be identifiable in any way.
How will the project benefit me?
iMindTime is a brief, user friendly and interactive program that you should find enjoyable. More importantly, you will acquire skills and knowledge of a way to increase your wellbeing.
Are there any risks from participating?
No health risks are expected from participating in this project, however, you may feel slightly uneasy when answering questions about past experiences and your beliefs and attitudes. If you feel concerned or distressed in any way from completing any of the assessments or using the iMindTime program, please contact a GP or Lifeline (available 24 hours a day: 131 114).
How do I participate?
Having read this Plain Language Statement and decided that you would like to participate in this project, please click on the “I agree to the above conditions” button below on your computer screen. Once you consent, the project will commence as outlined above (completion of the pre-program questionnaires). If you do not wish to participate in this study, please click the “I decline to participate” button and you will be taken back to your dashboard where you are able to choose another digital program, if you wish.
If you have any questions, would like further information or a summary of the results once completed regarding the project titled ‘A randomised controlled trial and consumer characteristics of iMindTime: A comprehensive mindfulness and loving kindness meditation wellbeing digital health program.’, please contact the Principal Researcher, Professor Britt Klein of the Faculty of Health: Telephone: 03 5327 6717, EMAIL: email@example.com
This research study has been approved by the university’s Human Research Ethics Committee. Should you (i.e. the participant) have any concerns about the ethical conduct of this research project, please contact the Federation University Ethics Officer, Research Services, Federation University Australia, PO Box 663, Mt Helen VIC 3353. Telephone: (03) 5327 9765, Email: firstname.lastname@example.org
CRICOS Provider Number 00103D
© 2020 MY DIGITAL HEALTH