Plain Language Information Statement
Plain Language Information Statement
A randomised evaluation trial of the LIFE FLeX digital health and wellbeing program for anxiety and depression.
Professor Britt Klein: DVC-R Portfolio
Other / Student Reseachers:
Professor Suzanne McLaren: School of Health & Life Sciences; Owen Cole: DVC-R Portfolio; Dr Cameron Foale: Faculty of Science & Technology; Asher Leslie & Lewis Lakerink: Technical Consultants to project; Brooke Andrews: School of Health & Life Sciences.
Thank-you for your interest in this study. We invite people who are aged 18 years and over, who have access to the internet and who experience anxiety and/or depressive symptoms to participate in this LIFE FLeX digital health study.
What is the project about?
This project seeks to determine the efficacy of the LIFE FLeX digital health program and the factors that predict people’s use of it. LIFE FLeX is a seven week self-help web and mobile program designed to help people decrease their anxiety and depressive symptoms and increase wellness.
The results from this project will be used by Federation University researchers in the development of future digital health 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 LIFE FLeX program.
Participants will be asked to:
- Create a ‘My Digital Health’ platform (the LIFE FLeX 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 LIFE FLeX program. Here you will need to agree to participate in the LIFE FLeX study after reading through this Plain Language Information Statement and by clicking the “I agree to the above conditions” below.
- Complete the pre-program questionnaire survey via this website. The questionnaire survey will ask you questions about yourself, including demographic details (e.g., age) and your mental health and wellbeing (e.g., depressive, anxiety symptoms, strategies that you use to deal emotional and stressful situations, your quality of life, time perception). The pre-program survey should take approximately 35 minutes to complete.
- Consent to be randomly allocated to one of 2 versions of LIFE FLeX: LIFE FLeX (Version A) or LIFE FLeX (Version B).
- The material covered in both versions is identical, consisting of six core modules and an introduction module; each session has 20 minutes of online activities, and 20-30 minutes of offline practise per week. There is also one brief booster session module to help consolidate what you have learnt at Week 11. The two versions only differ in terms of when the modules are made accessible.
- 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 LIFE FLeX program to record your sleep, heart rate, and number of steps per day.
- Complete two questionnaires at the start of Week 3 and 5 taking about 3-5 minutes to complete.
- Complete the post program questionnaires in Week 8, again asking you about your mental health and wellbeing. This should take you about 35 minutes to complete.
- Complete the 1 and 3 month follow-up questionnaires at Week 12 and Week 20, which also asks you about your mental health and wellbeing. These questionnaires should take you about 30 minutes to complete.
You are also able to request that we add your nominated healthcare practitioner to your program account (providing you and your practitioner reside in Australia). Your healthcare practitioner must be a qualified healthcare professional (e.g., psychologist, general practitioner) and you must first discuss this matter with them before completing the request form. You can access this request form by clicking the ‘Connect to Practitioner’ button on your program dashboard.
Adding your healthcare practitioner means that they will be able to view a copy of the LIFE FLeX program and you can communicate with them through our communication system (internal email, instant messaging, shared collaborative workspace, video-chat). We will only use the metadata created by you and/or your healthcare practitioner (e.g., how many internal emails you and your healthcare practitioner sent to each other, how many times you used the video-chat system). No text, video or audio content will be used or analysed. You are also able to specify whether they can view your account activity, progress graphs and self-monitoring data. You can also revoke their access by letting us know (i.e., ‘Contact Us’ form, internal email). Should you (or your healthcare practitioner) wish to stop interacting through your LIFE FLeX program account, we will inform your healthcare practitioner (or you) of this.
The LIFE FLeX digital health program will record how many times you logged in, what modules you accessed, the amount of time you spend using the program, whether you have added your nominated healthcare professional and the metadata related to this use (e.g., how many times you used My Digital Health to communicate with your healthcare practitioner [e.g., number of emails sent, number of video-chats conducted]). This information will not affect your use of the program. You will also be sent automated reminder emails/SMS’s during your 20 weeks while being involved in this study. You will be asked to complete a brief online questionnaire about your engagement levels with the program.
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, 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, yet subject to legal limitations (e.g., legal subpoena) and only be assessed by the investigators. Data is stored securely and we use 256-bit encryption Secure Sockets Layer and Transport Layer Security (SSL/TLS) software when information is transmitted. If you request the addition of your healthcare practitioner, you will also be asked what data they can view (i.e., access to your progress graphs, daily self-monitoring and account activity data). You can revoke their access to this data at any time. When we analyse any data, any identifying information is 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. The data will be stored securely for five years post any publications. After this time the data will be destroyed safely. 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?
The LIFE FLeX digital health program is a user friendly and interactive program that you should find easy to use. This program will provide you with skills and understanding to better manage your anxiety and/or depressive symptoms. Your input will also help us improve the program to help others who experience similar symptoms.
Are there any risks from participating?
No health risks are expected from participating in this project, although you may feel slightly anxious during the exposure exercises. You may also feel 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 LIFE FLeX digital health program, please contact a GP or Lifeline (available 24 hours a day: 131 114). Please note, if you opt to add your healthcare practitioner, please be aware that broadband speed, device and browser type can interfere with your connection. We recommend that you use a Firefox or Chrome browser, via a desktop computer or laptop device with good internet speed, for best results. Additionally, as we are not offering this service to you commercially, we cannot guarantee continuous uninterrupted service. It is important therefore that you have an alternative means by which to communicate with your healthcare practitioner, should service to the communication system be interrupted or you experience internet wifi or broadband coverage issues.
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 or would like further information regarding the project titled ‘A randomised evaluation trial of the LIFE FLeX digital health and wellbeing program for depression and anxiety’, or a summary of the results once the study is completed, please contact the Principal Researcher, Professor Britt Klein of the School of Health Sciences and Psychology: Phone: 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