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Plain Language Information Statement

 

Plain Language Information Statement

PROJECT TITLE: A ‘open study’ evaluation trial of the LIFE FLeX eHealth wellbeing program for anxiety and depression.
PRINCIPAL RESEARCHER: Professor Britt Klein: School of Health Sciences and Psychology, Centre of Biopsychosocial and eHealth Research & Innovation
OTHER/STUDENT RESEARCHERS: Professor Suzanne McLaren: School of Health Sciences and Psychology; Sue Lauder: School Health Sciences and Psychology; Lewis Lakerink: Director. Retsim Pty Ltd. Technical Consultant to project; Asher Leslie: Director. Retsim Pty Ltd. Technical Consultant to project; Brooke Andrews: School of Health Sciences and Psychology; Samantha Sarjeant: School of Health Sciences and Psychology.

 

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 eHealth study.

 

What is the project about?

This project seeks to determine the efficacy of the LIFE FLeX eHealth program and the factors that predict people’s use of it. LIFE FLeX eHealth is a seven week self help online 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 e-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 eHealth.

Participants will be asked to:

  • Complete the post intervention questionnaires in Week 8, again asking you about your mental health and wellbeing. This should take you about 30 minutes to complete.
  • Provided with immediate access to the LIFE FLeX ‘stage release’ program. Stage release means that you will need to complete the first module, before the second module will open and once you have completed the second, the third will open, etc. LIFE FLeX consists 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 booster session module that we recommend you work through a few weeks following post-program assessment and we will notify about this via email.
  • Create a registration account through this website. 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 confirm before you can proceed any further. Once confirmed you can then re-enter this website to access and complete the pre-program questionnaire survey. If you would like to remain anonymous, we suggest you use an email address that does not contain your first and last name.
  • Agree to participate in this study after reading through this Plain Language Information Statement by clicking the consent button below.
  • Complete the pre-program questionnaire survey. The questionnaire survey will asked you questions about yourself, including demographic details (e.g., age) and 9 questionnaires that ask you about your mental health and wellbeing (e.g., depressive, anxiety symptoms, strategies that you use to deal emotional and stressful situations, your quality of life, etc). The pre-program survey should take approximately 30 minutes to complete.
  • Complete a few weekly questions (e.g., asking if you have completed the offline activity) and two questionnaires at the start of Week 3 and 5. This should take 3-5 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 25 minutes to complete.

 

The LIFE FLeX eHealth program will record the how many times you logged in, what modules you accessed and 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 20 weeks while being involved in this study.

 

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 and stored securely using the Federation eHealth platform and linked survey management tool utilising the platforms 256-bit encryption SSL security certificate and can only be assessed 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. 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 is 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?

LIFE FLeX eHealth 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 eHealth program, please contact a GP, Life Line (available 24 hours a day: 131 114) or the MindSpot Clinic (available 7 days a week: www.mindspot.org.au). Alternatively, you can contact Prof Britt Klein from Federation University on 03 5327 6717 or by email (b.klein@federation.edu.au).

 

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 have read the Plain Language Information Statement and I agree to the above conditions.” button below on your computer screen. Once you consent, the project will commence as outlined above (study registration account and completion of the pre-monitoring questionnaires).

 

If you have any questions or would like further information regarding the project titled ‘A ‘open study’ evaluation trial of the LIFE FLeX eHealth 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:PH: 03 5327 6717EMAIL: 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.auCRICOS Provider Number 00103D