Participant Information Statement: Trial of the Inroads self-guided early intervention for anxiety and drinking among young adults.
1. What is this study about?
We are conducting a research study that aims to evaluate the effectiveness of two different psychological support programs for young adults. Both programs are based on effective treatment components, and this study will test which one is more effective. The first program is called the Inroads program, and it aims to enhance anxiety coping skills, explore the interconnection between anxiety and alcohol use, and help young people control their drinking. The second program is an Alcohol feedback program which will provide participants with personalised feedback about their alcohol use and risk level, as well as guidelines for safe alcohol use. Taking part in this study is voluntary. Please read this sheet carefully and ask questions about anything that you don’t understand or want to know more about.
2. Who is running the study?
The study is being carried out by the following researchers:
- A/Prof Lexine Stapinski, University of Sydney
- Prof Andrew Baillie, University of Sydney
- Dr Katrina Prior, University of Sydney
- Prof Nicola Newton, University of Sydney
- Prof Maree Teesson, University of Sydney
- Prof Tim Slade, University of Sydney
- Prof Paul Haber, University of Sydney
- Ms Tara Guckel, University of Sydney
- Ms Laura Wade, University of Sydney
- Dr Yong Yi Lee, Monash University
- Dr Mary Lou Chatterton, Monash University
- Prof Cathy Mihalopoulos, Monash University
- Dr Mark Deady, Black Dog Institute, University of New South Wales
- Prof Ronald Rapee, Macquarie University
- Prof Jennifer Hudson, Black Dog Institute, University of New South Wales
- Prof Frances Kay-Lambkin, University of Newcastle & Hunter Medical Research Institute
This study is being funded by the National Health and Medical Research Council (NHMRC).
3. Who can take part in this study?
Young adults with anxiety symptoms who want to reduce or manage their alcohol consumption can register for this study. After consent is provided, the first step as part of this study will be to complete a short survey to check that this study is right fit for your specific circumstances.
4. What will the study involve for me?
Step 1 - Suitability assessment: If you provide your consent after reading this Participation Information Statement, you will be asked to complete a brief 10-minute survey comprising questions that will be used to determine whether this study is suitable for you.
Step 2 - Baseline assessment: If you are eligible to participate, you will be asked to complete an additional survey about your experiences with anxiety and other mental health concerns and experiences, as well as your experiences with (and expectations around) drinking alcohol and/or taking other drugs. We will also ask you some basic demographic information, information about what health services you use, and some general information about your quality of life. We expect this survey will take 25-35 minutes to complete. At the end of this survey, we will also ask for information on how to contact you over the course of the study (name, phone number, email, and address) so that you can be contacted 2, 6, 12 and 18-months after the initial survey. If the Inroads study is not deemed suitable for you, we will provide you with a list of alternative options for seeking assistance and support.
Step 3 - Program allocation and program completion (5-weeks): After completing the baseline survey, you will be randomly allocated to receive one of two programs. Both programs are based on effective treatment components. Random allocation means that neither you nor the study team choose which program you receive; this is determined by chance (like a toss of a coin). You will have a 50% chance of receiving either:
- Inroads anxiety and alcohol program: This group will receive a program that involves 5 online modules which focus on developing skills to help you manage your anxiety and alcohol use. A new online module will be accessible each week, and in addition, you will receive weekly feedback via email, and a phone call from a support person at week 1 and 4.
- Alcohol-feedback program: This group will receive personalised feedback on their alcohol consumption and information about risks relating to alcohol use, and guidelines for safe levels of drinking
Step 4 - Follow-up surveys: Regardless of which condition you are randomly allocated to, you will be asked to complete online follow-up surveys 2, 6, 12 and 18-months after the initial survey. These follow-up surveys will take approximately 30 minutes to complete and will allow us to assess your progress and any benefits of the programs. We will also ask for your feedback about the program you participated in. In addition to the online surveys, at the 6month follow-up we will ask you to participate in a phone interview to further assess your mental health. These phone calls will be voluntary and will be conducted by a member of the research team and will be recorded.
5. Can I withdraw once I've started?
Being in this study is completely voluntary and you do not have to take part. Your decision will not affect your current or future relationship with the researchers or anyone else at The University of Sydney or other institutions involved in this research. If you decide to take part in the study and then change your mind later, you are free to withdraw at any time without giving a reason. Should you decide to discontinue your participation in the project at any time, you may fill in the Revocation of Consent form, accessible from the ‘information & consent’ tab on the Inroads project website (https://inroads.org.au/).
If you decide to withdraw, we will not collect any more information from you. Any information that we have already collected, however, will be kept in our study records and may be included in the study results. If you do not want your data to be included, you must tell the researchers when you withdraw from the project.
6. Are there any risks or costs?
There are no costs for participating in this study. Some people, however, may find it distressing to talk about or confront psychological issues, anxiety symptoms and/or problems with alcohol use. For example, part of the Inroads program involves facing anxiety provoking situations and developing new ways of coping with the anxiety you feel in these situations. While this can be distressing for some people, it is a commonly used treatment technique for improving anxiety, and its effectiveness is supported by extensive research evidence. You do not have to complete these tasks, although if you do not, it may reduce the effectiveness of the treatment.
There is also some risk that modifying alcohol use will be associated with withdrawal symptoms and an exacerbation of symptoms of anxiety. In fact, if your alcohol use is high, there are also some medical risks and we advise seeking medical advice before making any significant changes to your current alcohol use.
If you are concerned or become distressed at any stage during the study, we would encourage you to contact the services listed at the end of this information sheet, where you may obtain additional services and 24-hour support. You can also contact the study team at firstname.lastname@example.org who can provide you with additional support or referral options. Please not that there may be a delay to respond to your email, so for immediate assistance please contact one of the support services listed.
7. What happens when the study ends?
At each follow-up assessment (2, 6, 12 and 18 months) you will be provided with a list of mental health and alcohol and other drug support services. You can log back into the treatment program at any time throughout the 18-month study period if you would like to access the program content. At the end of the 18-month study period, access to the content will continue to be available for as long as the trial website is active.
8. Are there any benefits?
As a thank you for your time, participants will receive a $30 e-gift voucher for completing each of the four follow-up surveys (i.e., one after completion of the 2-month survey, another after the 6-month survey etc.). Participants who complete the phone interview will also receive a $30 e-gift voucher for their time. In addition, those allocated to the Inroads group who complete all 5 modules will receive a $30 Prezzee e-gift voucher (equivalent to approximately $5 per module). In this study you will have access to one of two programs. Both programs are based on effective treatment components that have shown benefits in past research to help people reduce their anxiety and/or alcohol use. Therefore, you can reasonably expect to see some direct benefits from participating in the trial
9. What will happen to information that is collected?
By providing your consent, you are agreeing to us collecting information about you for the purposes of this study. Any information you provide us will be stored securely and identifiable information will only be disclosed with your permission, unless we are required by law to disclose material. We anticipate study findings will be published. You will not be individually identifiable in these publications.
Data collected will include survey responses, program data such as module completions and module quiz scores, and diagnostic phone interview recordings. All data will be stored electronically on secure, password protected, servers at the University of Sydney. These can only be accessed research staff. We will keep your data for 20 years before disposing of it in a confidential manner.
We will keep the information we collect for this study, and we may use it in future projects. By providing your consent you are allowing us to use your information in future projects investigating mental health and substance use. Information will only be used in future projects that have received ethical approval.
We intend to share the information from this project with other researchers for use in individual patient data repositories, so that others can access it and use it in their research projects. Before we do so, we will take out all the identifying information so that the people we give it to won’t know whose information it is. They won’t know that you participated in the project, and they won’t be able to link you to any of the information you provided.
10. Will I be told the results of the study?
You have a right to receive feedback about the overall results of this study. You can tell us that you wish to receive feedback in the final (18-month) follow-up survey or by contacting the research team. After the study has been completed and results have been published, a one-page summary of the research findings can be emailed to you.
11. What if I would like further information?
When you have read this information, the following researcher will be available to discuss it with you further and answer any questions you may have:
Dr Katrina Prior, Project Manager: email@example.com or +61 2 8627 9032
12. What if I have a complaint or any concerns?
The ethical aspects of this study have been approved by the Human Research Ethics Committee (HREC) of The University of Sydney 2023/348 according to the National Statement on Ethical Conduct in Human Research (2007).
If you are concerned about the way this study is being conducted or you wish to make a complaint to someone independent from the study, please contact the University:
Human Ethics Manager: firstname.lastname@example.org l +61 2 8627 8176