Life Flex

Plain Language Information Statement

Plain Language Information Statement

 

Project Title:

A randomised evaluation trial of the Life Flex digital health and wellbeing program for anxiety and depression.

Principal Researcher:

 

Professor Britt Klein: Health Innovation & Transformation Centre, DVC-R Portfolio, Federation University

Other / Student Researchers:

Professor Suzanne McLaren, Owen Cole, Dr Cameron Foale, Brooke Andrews, Dr Kerrie Shandley, & Dr Huy Vannguyen.

 

Please note that the recruitment for the current Life Flex study has now closed.

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 an eight week self-help digital health program designed to help people decrease their anxiety and depressive symptoms and increase wellness.

The results from this project will be used by the researchers in the development of future digital health programs that will be made available to the general public. Please note, for this trial we can only include people who are currently residing in Australia.

 

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 ‘HealthZone’ platform (the Life Flex digital health program is one program amongst others that are housed within the HealthZone 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. To remain anonymous, we suggest you use an email address that does not contain your first and last name.
    • Once you have created a HealthZone 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” button 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). The pre-program questionnaire should take approximately 25 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. The two versions only differ in terms of when the modules are made accessible.
    • Complete a daily mood and lifestyle activities 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 a weekly brief check-in survey at the start of each week (Week’s 1-8) asking you about your module reading and offline activity progress. This should take 1 minute to complete.
    • Complete a brief usability questionnaire (you will be asked in the second week) which asks you how easy the program is to use. This should take you 2-3 minutes to complete.
    • Complete two questionnaires at the start of Week 3, 5 & 7 taking about 3-5 minutes to complete. These two questionnaires will ask you about any anxiety and depressive symptoms.
    • Complete the post program questionnaires in Week 9, again asking you about your mental health and wellbeing and impression of the program. This should take you about 30 minutes to complete. Participants who complete the post assessment questionnaires will receive a $10 gift card e-voucher for their time.
    • Complete the 3-month follow-up questionnaire at Week 21, which also asks you about your mental health and wellbeing. These questionnaires should take you about 25 minutes to complete. Participants who complete the 3-month follow-up assessment questionnaire will receive a $10 gift card e-voucher for their time.
    • Participants may be invited via email (through the HealthZone internal email system) to participate in a 15-minute semi-structured interview (conducted via video-chat, instant messaging or telephone) to share their experiences of using the Life Flex program and HealthZone platform. Participants will receive a $20 gift card e-voucher for their time.

    The Life Flex digital health program will also record your usage of the program (e.g., how many times you logged in, what modules you accessed, and the amount of time you spend using the program). This information will not affect your use of the program. You will also be sent automated reminder emails whilst being involved in this study. You can also access ‘ALEX’ while doing the Life Flex program. ALEX is an automated digital support designed to assist you to get back on track if your motivation levels start to fall whilst doing the Life Flex 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. When we analyse any data, any identifying information is completely removed and therefore cannot be linked back to you in any way. Your de-identifiable data may be used for research projects into the future such as being re-analysed or added to other digital mental health data to answer other research questions. Any other person, apart from current researchers, gaining access to the data, will only be supplied with non-identifiable data and can only receive it for a legitimate research purpose (e.g., data use for a future thesis project). The data will be stored securely for five years post any publications. At some stage 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 (with the exception of the use of quotes obtained through semi-structured interviews; de-identified), 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.

     

    Will taking part in this study cost me anything, and will I be paid?

    Participants who are invited to share their Life Flex program experiences with us will be offered a $20 gift card e-voucher upon completion. As stated above, these interviews are estimated to take approximately 15 minutes of time and can be completed either via the phone, video-chat, or instant messaging. Participants will also be offered a $10 gift card e-voucher upon completion of the post-program questionnaire assessment (Week 9) and 3-month follow-up assessment (Week 21).

     

    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). We recommend that you use a Firefox or Chrome browser, via a desktop computer or laptop device preferably, with good internet speed, for best results. Additionally, as we are not offering this service to you commercially, therefore we cannot guarantee continuous uninterrupted service.

     

    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 Health Innovation & Transformation Centre, DVC-R Portfolio: Phone: 03 5327 6717, EMAIL: b.klein@federation.edu.au     

      

     

    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: research.ethics@federation.edu.au

    CRICOS Provider Number 00103D