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Plain Language Information Statement

 

Plain Language Information Statement

 

PROJECT TITLE: A randomised controlled trial evaluating the effectiveness of a one module eHealth wellbeing program (THRIVE) on increasing wellbeing and decreasing stress.
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; Lewis Lakerink: Director. Retsim Pty Ltd. Technical Consultant to project; Asher Leslie: Director. Retsim Pty Ltd. Technical Consultant to project

 

Thank-you for your interest in the THRIVE eHealth 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 brief THRIVE eHealth program (a brief, one module, tools-based online 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 THRIVE eHealth program.

Participants will be asked to:

  • Agree to participate in this study after reading through this Plain Language Information Statement by clicking the “I have read the Plain Language Information Statement and I agree to the above conditions.” below.
  • 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 verify before you can proceed any further. Once confirmed you can then re-enter this website to access and complete the pre-intervention questionnaires. If you would like to remain anonymous, we suggest you use an email address that does not contain your first and last name.
  • Complete the pre-intervention 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 emotional and stressful situations). The pre-intervention questionnaires should take approximately 15-20 minutes to complete.
  • Randomly allocated to either the immediate access or delayed access (delayed by 7 weeks) to the THRIVE eHealth program groups.
    • Immediate Access. You will receive immediate access to the brief THRIVE eHealth program. The program consists of one module, split into 6 wellbeing sections; each section will take about 5 minutes to read and 10 minutes of activities (e.g., guided audios, knowledge self tests)
    • 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 (Week 7) to access the program.
  • Complete two weekly questionnaires (e.g., how optimistic you are feeling) at the start of Week 1 and Week 2. This should take 3-5 minutes to complete.
  • Complete the post intervention questionnaires in Week 3, 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 brief THRIVE eHealth program. This should take you about 15-20 minutes to complete.
  • Complete the 1 month follow-up questionnaires at Week 7, which also ask you about your mental health and wellbeing. Once completed, the delayed access group will then be able to access the THRIVE eHealth program and will be asked to complete the post-intervention questionnaires in Week 9, again asking you about your mental health and wellbeing and satisfaction with the THRIVE eHealth program. These questionnaires should take you about 15-20 minutes to complete.

 

The brief THRIVE eHealth 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 9 (delayed start group) and 7 (immediate start group) weeks while being involved in this study. You will be able to continue to access the THRIVE eHealth program for another 12 weeks following your last assessment schedule notification.

 

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 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. All 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?

THRIVE eHealth 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 THRIVE eHealth program, please contact a GP or Life Line (available 24 hours a day: 131 114). 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.” radio button below on your computer screen. Once you consent, the project will commence as outlined above.

 

If you have any questions or would like further information regarding the project titled ‘A randomised controlled trial evaluating the effectiveness of a one module eHealth wellbeing program (THRIVE) on increasing wellbeing and decreasing stress, 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 PsychologyPH: 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