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Plain Language Information Statement

 

Plain Language Information Statement

 

PROJECT TITLE: A open trial evaluation of the BDZ (information and reduction) eHealth program for people using benzodiazepines.
PRINCIPAL RESEARCHER: Professor Britt Klein: School of Health Sciences and Psychology, Centre of Biopsychosocial and eHealth Research & Innovation
OTHER/STUDENT RESEARCHERS: Janet Shaw: Reconnexion; Janet Haynes: Reconnexion; A/Professor Peter Schattner: Department of General Practice, Monash University; Professor Suzanne McLaren: School of Health Sciences and Psychology; Sue Lauder: Research Associate 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

 

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 telephone and who are thinking about or who want to reduce their benzodiazepine intake gradually, to participate in this BDZ eHealth study.

Due to a few requirements for this study, participants must also be living in Australia, cannot have a currently untreated severe (psychotic) mental illness, and will not use the ‘cold turkey’ method (i.e., complete withdrawal from using their benzodiazepine medication) should they reduce their benzodiazepine usage while participating in the study.

 

What is the project about?

This project seeks to determine the efficacy of the BDZ eHealth program and the factors that predict peoples’ use of the BDZ eHealth program. BDZ eHealth is a 6 week online program designed to inform people about benzodiazepines, its dependency, and safe ways to reduce use. It also provides useful strategies to help people when they experience withdrawal effects from gradually reducing their benzodiazepine use.

The results from this project will be used by Federation University and Reconnexion researchers in the development of future BDZ eHealth 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 BDZ eHealth.

Participants will be asked to:

  • Agree to participate in this study after reading through this Plain Language Information Statement by clicking the consent button below and then complete five screening questions confirming your eligibility for this study (e.g., that you are 18 years of age or older).
  • 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.
  • Complete the pre-monitoring questionnaire survey via this website. The questionnaire survey will ask you questions about yourself, including demographic details (e.g., age) and 11 questionnaires that ask you about your benzodiazepine use and dependency (e.g., current benzodiazepine dosage), and 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.
  • Following this you will be given immediate access to the BDZ eHealth program. The BDZ eHealth program consists of five core modules and an Introduction module; each module will require about 20 minutes. During this time we also strongly encourage you to use the Reconnexion benzodiazepine telephone support service, however it is entirely up to you if you do and if you disclose your participation in this study to the telephone support worker. Should you decide to commence reducing your benzodiazepine dosage, we strongly recommend that you involve your GP first.
  • Complete a few weekly questions (e.g., asking whether you have spoken with one of the Reconnexion benzodiazepine counsellors) and two questionnaires at the start of Week 3. This should take 5 minutes to complete.
  • Complete the post intervention questionnaires in Week 6, again asking you about your benzodiazepine use and mental health and wellbeing. This should take you about 25-30 minutes to complete.
  • Complete the 1 and 3 month follow-up questionnaires at Week 10 and Week 18, which also asks you about your benzodiazepine use and mental health and wellbeing. These questionnaires should take you about 25-30 minutes to complete.

 

The BDZ eHealth program will record how many times you logged in, what modules and resources 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 the 18 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 of the intervention and follow up time points, without having to provide any explanation. Your withdrawal will have no impact on current or future relationships with Federation University or Reconnexion.

 

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 (including email addresses) 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?

BDZ eHealth is a user friendly and interactive program that you should find enjoyable to use.  This program will provide you with information and a better understanding about benzodiazepines and its reduction, as well as how to better manage reduction/withdrawal effects. 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. However, as stressed throughout the BDZ eHealth program, we strongly discourage anyone for going ‘cold turkey’ (that is, stopping your medication completely, rather than reducing the dosage gradually) and we require you to agree not to use the ‘cold turkey’ method should you wish to stop taking benzodiazepines. We also strongly encourage you to speak with a Reconnexion benzodiazepine support worker to discuss the program and its contents whilst doing the program and that you involve your GP should you decide to reduce your benzodiazepine dosage.

You may 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 BDZ eHealth program, please contact a Reconnexion benzodiazepine specialist support worker on 1300 273 366, your 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 trial evaluation of the BDZ (information and reduction) eHealth program for people using benzodiazepines’, 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.auCRICOS Provider Number 00103D