Participant information & consent form
Pilot study to prevent the exacerbation of anxiety and alcohol use comorbidity through brain training
(1) What is this study about?
You are invited to take part in research study that aims to examine the feasibility, acceptability and efficacy of an age-appropriate, online brain training program for young Australians who experience anxiety symptoms and problematic alcohol use.
Most treatments that currently exist for anxiety and alcohol use problems seek to change unhealthy thoughts and behaviours at a conscious or explicit level (e.g. Cognitive Behavioural Therapy). However, many people indicate that their anxiety and alcohol consumption is not always a conscious choice. Supporting this, there is accumulating evidence that anxiety and drinking are affected by processes operating at a subconscious, implicit level. For instance, people with alcohol use problems have an implicit “approach bias”, where they are automatically drawn to approach or seek alcohol. An approach bias can be triggered very quickly, so people aren’t even fully aware they’re being influenced by it. This can make drinking very difficult to control. Thankfully, scientific research has shown that these subconscious, automatic thoughts and behaviours can be changed via “brain training” programs (known as Cognitive Bias Modification). As with other habits, such as typing, driving or cycling, repeated exercise (or in this case repetitive completion of a brain training task) allows an individual to develop new automatic thoughts and behaviours. In turn, by re-training these maladaptive subconscious tendencies, we aim to reduce young people’s anxiety and drinking behaviour.
This Participant Information Statement tells you about the research study. Knowing what is involved will help you decide if you want to take part in the research.
Please read this sheet carefully and ask questions about anything that you don’t understand or want to know more about. At the end of the Consent Form, if you are interested in being part of this research, please press the ‘I agree’ button. If you are not interested in participating and do not wish to be contacted further, please press the ‘I do not agree’ button.
Participation in this research study is voluntary.
By giving your consent to take part in this study you are telling us that you:
- Understand what you have read.
- Agree to take part in the research study as outlined below.
- Agree to the use of your personal information as described.
You can print a copy of this Participant Information Statement for you to keep.
(2) Who is running the study?
The study is being carried out by the following researchers:
- Dr Katrina Prior, from the University of Sydney, Sydney, Australia
- Dr Lexine Stapinski, from the University of Sydney, Sydney, Australia
- Prof Reinout Wiers, from the University of Amsterdam, The Netherlands
- A/Prof Elske Salemink, from Utrecht University, The Netherlands
- Prof Bethany Teachman, from University of Virginia, Virginia, USA
- A/Prof Nicola Newton, from the University of Sydney, Sydney, Australia
- Prof Maree Teesson, from the University of Sydney, Sydney, Australia
- Prof Andrew Baillie, from the University of Sydney, Sydney, Australia
- Dr Victoria Manning, from Monash University, Melbourne Australia
- Dr Alison Mahoney, from St Vincent’s Public Hospital, Sydney, Australia
- Dr Lauren McLellan, from Macquarie University, Sydney, Australia
- Ms Briana Lees, from the University of Sydney, Sydney, Australia
- Ms Jennifer Debenham, from the University of Sydney, Sydney, Australia
- Mr Samuel Campbell, from Monash University, Melbourne Australia
- Ms Monique Piggott, from the University of New South Wales, Sydney, Australia
This study is being funded by an Early Career Researcher Seed Funding Grant from The Prevention and Early Intervention in Mental Illness and Substance Use (PREMISE) Centre of Research Excellence, and a Seed Funding Grant from the University of Sydney Lifespan Research Network. The Chief Investigator is also in receipt of salary support from a Royce Abbey Australian Rotary Health Postdoctoral Fellowship.
(3) What will the study involve for me?
If you decide to take part in the research study, you will be required to complete the steps below:
Complete a brief 10-minute survey comprising questions that will be used to determine whether this study is suitable for you. If the study is not suitable for you, we will provide you with a list of alternative options for seeking assistance and support.
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 (e.g. sleep), your experiences with (and expectations around) drinking alcohol and/or taking other drugs. You will then be asked to complete a cognitive assessment that will measure your subconscious, automatic tendencies to think in certain ways. These will take approximately 45-50 minutes (combined) to complete and you will receive a $30 Prezzee gift voucher once you have completed both tasks.
Once the initial survey and cognitive assessments are completed, you will be randomly allocated to one of three groups. 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 chance of receiving either:
- The ‘integrated’ brain training intervention, which re-trains both anxiety and alcohol biases within each session (i.e. sessions comprise 50:50 focus on anxiety and alcohol), plus treatment as usual
- 1. The ‘alternating’ brain training intervention, which re-trains anxiety biases in one session and alcohol biases in the next session (i.e. there are 10 sessions, with 5 sessions focused on anxiety and 5 sessions on alcohol), plus treatment as usual
- Treatment as usual only
Regardless of which condition you are randomly allocated to, you will be asked to complete a brief (5-minute) assessment about your anxiety symptoms and alcohol use each week. As a thank you for your time, you will receive a $5 Prezzee e-gift voucher for each of the 10 assessments, with an accumulated voucher paid at the end of the 5-week period.
Lastly, you will be asked to complete an online survey and cognitive assessment 6-weeks and 3-months after the initial survey. These follow-up surveys and cognitive assessments will take approximately 45-50 minutes (combined) to complete, and will allow us to assess your progress and any benefits of the program. We will also ask for your feedback about the program you participated in. Participation in the follow-up surveys/cognitive assessments is voluntary. However, to help us accurately measure the effects of the brain training, we encourage you to complete the these tasks regardless of which group you were in or whether your anxiety and/or drinking has changed. You will receive a $30 Prezzee gift voucher at each timepoint.
If you were allocated to the treatment as usual only group, you will be offered the opportunity to receive one of the brain training programs following completion of the 3-month follow-up survey.
(4) How much of my time will the study take?
We expect the online surveys and cognitive assessment will take approximately 45-50 minutes to complete (combined) at each of the three time points (i.e., the initial assessment, 6 weeks later, and 3-month later). The brain training intervention consists of 10 x 20-30minute sessions, designed to be completed twice per week over a 5-week period.
(5) Do I have to be in the study? Can I withdraw from the study once I've started?
Being in this study is completely voluntary and you do not have to take part. Your decision whether to participate will not affect your current or future relationship with the researchers, the funders, members of your treatment service or anyone else at the University of Sydney or other institutions conducting 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 contact the research team directly via email (email@example.com) or phone (02 8627 9032) and tell them you no longer want to participate. After you withdraw, the researchers will not collect additional personal information from you. However, personal information already collected before you withdrew will be retained to ensure that the results of the research project can be measured properly and to comply with law. You should be aware that data collected up to the time you withdraw will form part of the research project results. If you do not want your data to be included, you must tell the researchers when you withdraw from the research project.
(6) Are there any risks or costs associated with being in the study?
The brain training tasks involve viewing images of alcohol and objects related to alcohol use. The questionnaires include questions about recent use of alcohol and other drugs. There is some risk that the tests or surveys may therefore be upsetting or increase craving for alcohol. We believe this risk is small, but if you feel distressed or experience increased cravings, please let the researcher know so they can provide support or arrange support
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. Some people may find also it distressing to talk about or confront psychological issues, including anxiety symptoms. If you are concerned or become distressed at any stage, 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.
There are no costs to you associated with participating in this research project. If you choose to participate you also have the right to stop completing the survey, cognitive assessments or brain training at any time and withdraw from the study.
(7) Are there any benefits associated with being in the study?
We cannot guarantee or promise that you will receive any benefits from this research. However, possible benefits of participating in the brain training may include a reduction in anxiety and reduced alcohol consumption.
As a thank you for your time and involvement in our research, will provide you an AUD$30 Prezzee e-gift card at the completion of the survey and cognitive assessment at each of the three time points. If you withdraw prior to the completion of one of the survey/cognitive assessment, no reimbursement will be provided. In addition, you will be asked to complete two weekly 5-minute assessments of your anxiety and alcohol use, for which you will receive a $5 Prezzee e-gift voucher per completion (10 total), with an accumulated voucher paid at the end of the treatment period (maximum $50 voucher).
(8) What will happen to information about me that is collected during the study?
By clicking on the ‘I agree’ button, you are agreeing to us collecting personal information about you for the purposes of this research study. The online survey is hosted by Qualtrics (www.qualtrics.com). If you agree to participate in this study, the responses provided in the survey will be stored in these programs in computerised format, accessible only to research staff. Once we have completed our data collection, we will import the data and store it securely and confidentially on a secure server at the University of Sydney. Data will only be stored in password protected files, accessible to research staff.
Your identity/information will be kept strictly confidential, except as required by law or when there is an immediate and specified risk of harm that can only be averted by disclosing information. A serious and imminent threat to harm yourself or others may be subject to reporting to a third person. Any information concerning the protective safety of children is subject to reporting to relevant authorities. We will keep your data for 20 years before being confidentially disposed.
We intend to publish the findings of this study in scientific journals and to present the findings at scientific conferences. In any publication or presentation of this study, information will be provided in such a way that you cannot be identified. Publicly presented data will only include numerical data and statistical analyses. They will not include descriptions of your personal history or any other information which may identify you
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. We don’t know at this stage what these other projects will involve. We will seek ethical approval before using the information in these future projects. By providing your consent, you are agreeing to us collecting personal information about you for the purposes of this research study. Your information will only be used for the purposes outlined in this Participant Information Statement, unless you consent otherwise.
(9) Can I tell other people about the study?
Yes, you are more than welcome to tell other people about the study.
(10) What if I would like further information about the study?
If you want any further information concerning this project or if you have any problems which may be related to your involvement in the project, you can contact Dr Katrina Prior by email (firstname.lastname@example.org) at any stage during the study.
(11) Will I be told the results of the study?
You have the right to receive feedback about the overall results of this study. You can tell us that you wish to receive feedback by contacting Dr Katrina Prior (email@example.com). This feedback will be in the form of a one-page summary which we can email or post to you. You will receive this feedback after the study is finished.
(12) What if I have a complaint or any concerns about the study?
Research involving humans in Australia is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this study have been approved by the HREC of the University of Sydney [2020/135]. As part of this process, we have agreed to carry out the study according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect people who agree to take part in research studies.
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 using the details outlined below. Please quote the study title and protocol number.
The Manager, Ethics Administration, University of Sydney:
If you need emergency support, dial ‘000' for the police or an ambulance. Stay on the line, speak clearly, and be ready to answer the operator's questions. Alternatively, call Lifeline, a free and confidential 24-hour crisis helpline, on 13 11 14
If you are in a crisis situation, are concerned about feelings or thoughts of suicide, or need to speak with someone urgently, we urge you to contact the following organisations for immediate assistance:
If you feel you require assistance and support for mental health or drug and alcohol concerns, we encourage you to contact one of the following services:
Mental Health Issues, Low Mood, Anxiety and Stress
- Contact your family doctor or general practitioner
- Headspace (1800 650 890 or www.headspace.org.au) provide face to face, phone or online support for young people
- SANE (1800 187 263 or www.sane.org) provide face to face, phone or online support.
- Beyond blue (1300 224 636); online chat www.beyondblue.org.au/get-support/get-immediate-support
- Mindspot provide free online treatment for young people experiencing mood or anxiety issues www.mindspot.org.au/mood-mechanic
- Mental Health Access Line: free mental health telephone access across all states in Australia
- NSW (1800 011 511) – Mental Health Line
- VIC (1300 363 746) – Psychiatric triage (information, assessment and referral) 24 hours a day, 7 days a week
- ACT (1800 629 354) – Mental Health Triage Service
- QLD (1300 64 22 55) - 24-hour specialist mental healthcare
- TAS (1800 332 388) – Mental Health Services Helpline
- SA (13 14 65) – Mental Health Triage Service
- WA (1800 676 822) – Mental Health Emergency Response Line
- NT (1800 682 288) – Northern Territory Crisis Assessment Telephone Triage Service
Drug and Alcohol Concerns
- Counselling Online (1800 888 236) or www.counsellingonline.org.au: Free drug and alcohol online counselling available 24/7
- Reach Out (www.reachout.com): practical tools and support to help young people get through everything from everyday issues to tough times
- Youth Drug and Alcohol Advice (YoDAA) Line (1800 458 685): Telephone information and advice for young people
State-based health services:
- Alcohol & Drug Information Service: for information, services in your area, crisis counselling and support about alcohol and drugs:
- NSW: 1800 422 599 for regional NSW or 02 9361 8000 for metropolitan NSW
- VIC: Directline (1800 888 236)
- ACT: community health service: 02 6207 9977
- QLD: 1800 177 833 for regional QLD or 07 3837 5989 for metropolitan QLD
- TAS: 1800 811 994
- SA: 1300 131 340 or 08 8363 8618
- WA: 1800 198 024 for regional WA or 08 9442 5000 for metropolitan WA
- NT: 1800 629 683 or call 08 8922 8399 (Darwin) to book an appointment to seek help for alcohol withdrawal