Explanatory statement
Barwon Health
Participant Information and Consent Form
Version 2 Dated 7th April, 2008
Site Barwon Health: Geelong
Full Project Title: MoodSwings: An online intervention program for bipolar affective disorder
| Principal Researcher: | Professor Michael Berk |
| Associate Researcher(s): | Dr. Seetal Dodd Professor David Castle Dr. Andrea Chester Ms. Sue Lauder |
This Participant Information and Consent Form contains 14 major points.
1. Your Consent
You are invited to take part in this research project.This Participant Information contains detailed information about the research project. Its purpose is to explain to you as openly and clearly as possible all the procedures involved in this project before you decide whether or not to take part in it.
Please read this Participant Information carefully. Feel free to ask questions about any information in the document. You may also wish to discuss the project with a relative or friend or your local health worker. Feel free to do this.
Once you understand what the project is about and if you agree to take part in it, you will be asked to indicate your consent by clicking the consent button on the online Consent Form. By doing this, you indicate that you understand the information and that you give your consent to participate in the research project.
You are able to print a copy of the Participant Information and Consent Form to keep as a record or one can be posted to you if you prefer.
2. Purpose and Background
The purpose of this project is to see if an online program for bipolar disorder can help reduce episodes of illness and improve quality of life between episodes.A total of 130 people will participate in this project.
Previous experience has shown that in addition to medication people with bipolar disorder can benefit from psychosocial interventions. However access to these programs can be difficult. A number of psychological interventions are now being delivered online, such as for depression and anxiety. The results of these studies are encouraging and suggest that a similar approach for bipolar disorder has merit.
You are invited to participate in this research project because you have been diagnosed by your doctor as having bipolar disorder.
The results of this research will also be used to help researcher Sue Lauder obtain a PhD.
3. Procedures
This project involves you participating in an online self-help program for bipolar disorder via a secure website called MoodSwings. There are up to 6 modules in the program. You will be taken through these modules in sequence. The program is of 3 months duration, with 3 booster or review modules at 3 months, 6 months and 12 months. When and how long you spend on the program is entirely up to you, but so you can progress through the program in order, you will have 2 weeks for each module. There are some questionnaires before each of the modules, which ask you questions about your mood, daily life, social support, episodes of illness sense of control, medication, and how you have found the program. At the very beginning of the program we will also ask you some questions about you, and your experience of bipolar disorder. The program also has a discussion board moderated by one of the researchers (Sue Lauder). You will be invited to participate in the group discussion, but again, how often or if you do this at all is entirely up to you. Non-identifying material from the site may be used in reporting on the projects progress and final outcome, to highligh peopl'e experience of the program and bipolar disorder. After completing the modules we will ask you complete similar questionnaires as part of the review modules at 3, 6 and 12 months. The maximum time these questionnaires will take at any time is about 20 minutes. These questionnaires will help us to determine whether or not the program is of benefit. To help remind you of the 6 and 12 months booster modules and questionnaires, we will send you a reminder email around the time they are due. Over the 12 month period of the study you are able to access the website whenever you wish. As part of seeing how people utilize the website and which sections seem most useful, information on how long people spend on the site and the sections of the site they visit is automatically recorded.
As there is no clear evidence as to what type of online programs are most effective, there are two different forms of the MoodSwings website, program A and program B. When we have a group of 12 people who agree to participate in the study, a computer program will randomly allocate 6 people to program A and 6 people to program B. You will have an equal chance of being allocated to either program. This also means that as you go through the website there will be 5 other people that you can communicate, and share things with, as you wish, via the discussion board. At the end of the 12 months, both groups will have access to the other program if they wish.
Once you have been allocated to either program A or B your login details will be activated for you to access the site. During the first week you have access to the program you will be contacted by the researcher by phone or email to ensure you are not having any difficulties. Both programs also contain site tour which explains the program and how to navigate in it as well there is a help button which enables you to contact the researcher at any time if you are experiencing difficulties with the program.
4. Possible Benefits
Although we cannot promise or guarantee, we hope that by participating in this project you will experience an improvement in the severity and episodes of illness and have an improved quality of life. Additionally we feel the project enables you to learn more about bipolar disorder, enables the opportunity of sharing your thoughts and experiences with a small online community.
5. Possible Risks
For some people thinking about issues related to their illness can be distressing. Both program A and B contain links and contact details of services and agencies which may be helpful. You can of course suspend or discontinue your participation in this project if distress occurs. There may be additional unforseen or unknown risks.6. Alternatives to Participation
Currently we are not aware of any equivalent publicly accessible online interventions for bipolar disorder.
7. Privacy, Confidentiality and Disclosure of Information
Any information obtained in connection with this project and that can identify you will remain confidential. It will only be disclosed with your permission, except as required by law. If you give us your permission by signing the Consent Form, we plan to present the findings of the progress and overall findings of the study at academic conferences and in peer review journals. In any publication or presentation, information will be based on group data and provided in such as way that you cannot be identified.
8. New Information Arising During the Project
During the research project, new information about the risks and benefits of the project may become known to the researchers. If this occurs, you will be told about this new information. This new information may mean that you can no longer participate in this research. If this occurs, the person(s) supervising the research will stop your participation. In all cases, you will be offered all available care to suit your needs and medical condition.
9. Results of Project
Results of the project will be posted on the public access page of the MoodSwings website at www.moodswings.net.au as well as a more detailed report sent to you via email at the conclusion of the project.
10. Further Information or Any Problems
If you require further information or if you have any problems concerning this project, you can contact the principal researcher or Sue Lauder. The researchers responsible for this project are:
| Professor Michael Berk | +61 3 5226 7450 | mikebe@barwonhealth.org.au |
| Dr Seetal Dodd | +61 3 5226 7666 | settald@barwonhealth.org.au |
| Professor David Castle | +61 3 9288 4651 | David.CASTLE@svmh.org.au |
| Dr Andrea Chester | +61 3 9925 3150 | andrea.chester@rmit.edu.au |
| Ms Sue Lauder | +61 3 5226 7488 | suela@barwonhealth.org.au |
11. Other Issues
If you have any complaints about any aspect of the project, the way it is being conducted or any questions about your rights as a research participant, then you may contact
| Name: | Ms Bernice Davies |
| Position: | Secretary of Barwon Health Research and Ethics Advisory Committee |
| Telephone: | +61 3 5226 7978 |
You will need to tell Bernice the name of one of the researchers given in section 10 above.
12. Participation is Voluntary
Participation in any research project is voluntary. If you do not wish to take part you are not obliged to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.
Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your routine treatment, your relationship with those treating you or your relationship with Barwon Health.
Before you make your decision, a member of the research team will be available to answer any questions you have about the research project. You can ask for any information you want. Sign the Consent Form only after you have had a chance to ask your questions and have received satisfactory answers.
If you decide to withdraw from this project, please notify a member of the research team before you withdraw. This notice will allow that person or the research supervisor to inform you if there are any health risks or special requirements linked to withdrawing.
13. Ethical Guidelines
This project will be carried out according to the National Statement on Ethical Conduct in Research Involving Humans (June 2007) produced by the National Health and Medical Research Council of Australia. This statement has been developed to protect the interests of people who agree to participate in human research studies.
The Human Research Ethics Committee of Barwon Health has approved the ethical aspects of this research project.
14. Reimbursement for your costs
You will not be paid for your participation in this project.
However, as recognition of your participation a $20AUD Amazon gift voucher will be forwarded to you if you have completed all program review modules at 12 months.
To register your interest to participate in this study click on the registration form link to register.