Plain Language Information Statement

Plain Language Information Statement

Project Title: An open evaluation trial of the ‘LIFE FLeX 4 PTSD’ digital health program for post traumatic stress, anxiety and depressive symptoms.
Principal Researcher: Professor Britt Klein: DVC-R Portfolio
Other / Student Researchers: Prof Suzanne McLaren: School of Health & Life Sciences; Asher Leslie: DVC-R Portfolio; Dr Cameron Foale: Faculty of Science & Technology; Lewis Lakerink: Technical Consultant to project; Lachlan Kent: School Health & Life Sciences  (PhD Student).

 

 

Thank-you for your interest in the ‘LIFE FLeX 4 PTSD’ 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 eight week, biopsychosocially-focused post traumatic stress program designed to decrease symptoms of post traumatic stress, anxiety and depression and increase wellbeing. This program was developed using evidence-based techniques and it is designed to help people better deal with their post traumatic stress symptoms, as well as 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 digital health programs that will be made available to the general public, as well as in the partial fulfillment of Lachlan Kent’s PhD degree.

What does this project involve?

The project involves collecting various pieces of information from you and your usage of the ‘LIFE FLeX 4 PTSD’ My Digital Health program.

Participants will be asked to:

  • Create a ‘My Digital Health’ platform (the LIFE FLeX 4 PTSD 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 4 PTSD program. Here you will need to agree to participate in the LIFE FLeX 4 PTSD digital health 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 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., your post traumatic stress symptoms, how anxious you are, the strategies that you use to deal with emotional situations, time perception). The pre-program questionnaires should take approximately 40 minutes to complete. Please note: If your responses to the PTSD symptom questionnaire indicates that you do not have PTSD symptoms (e.g., you have not experienced a traumatic event), we will inform you of this and then redirect you back to the My Digital Health dashboard. Here you will be able to choose from one of our other programs that may be more suitable.
  • Receive immediate access to the LIFE FLeX 4 PTSD digital health program.
    • You will receive immediate access to the program and the program consists of an Introduction module and six core modules. Each module will take about 25 minutes to read and 30 minutes of offline activities, all aimed at increasing your life flexibility (biologically, emotionally, cognitively, and behaviourally and increase wellness levels).
  • 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. This will allow you to self-monitor your mental health and wellbeing more efficiently. If you have a Fitbit device, you are also able to integrate it to the LIFE FLeX 4 PTSD digital health program to record your sleep, heart rate and number of steps per day.
  • Complete two questionnaires (e.g., your psychological distress and optimism levels) at the start of Week 3, 5, and 7. This should take 3-5 minutes to complete.
  • Complete the post program questionnaires in Week 9, again asking you about your mental health and wellbeing and we will also ask you about your satisfaction with the LIFE FLeX 4 PTSD program. This should take you about 30 minutes to complete.
  • Complete the 1 and 3 month follow-up questionnaires at Week 13 and Week 21, which also ask you about your mental health and wellbeing. These questionnaires should take you about 25 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 4 PTSD 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 – PTSD program account, we will inform your healthcare practitioner (or you) of this.

The LIFE FLeX 4 PTSD digital health program will record your usage of the program (e.g., how many times you logged in, the amount of time spent 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 during your 21 weeks while being involved in this study and alerts should your mood scores decline. You will be able to continue to access the LIFE FLeX 4 PTSD program for another 8 weeks following your last follow-up assessment in Week 29.

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, 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 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. 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?

The LIFE FLeX 4 PTSD program for PTSD, is a user friendly and interactive program that you should find enjoyable. More importantly, you may acquire skills and knowledge ways to decrease your PTSD symptoms and increase your wellbeing.

Are there any risks from participating?

No physical 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 LIFE FLeX 4 PTSD 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 speeds, 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 ‘An open evaluation trial of the ‘LIFE FLeX 4 PTSD’ digital health program for post traumatic stress, anxiety and depressive symptoms, or a summary of the results once the study is completed, please contact the Principal Researcher, Professor Britt Klein of the 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