Participant Information Statement and Consent Form An Open Trial of Internet-based Treatment of Anxiety Symptoms in Older Adults Invitation Thank you for volunteering for this research study into an internet-based treatment of anxiety in older adults (the Managing Stress and Anxiety Program). The study is being conducted by Dr Nickolai Titov Director of the VirtualClinic, St Vincent s Hospital, Sydney; Professor Gavin Andrews - Director of the Clinical Research Unit for Anxiety and Depression (CRUfAD), at St Vincent s Hospital, Sydney, and Dr Blake Dear - a Clinical Psychologist at the VirtualClinic. All three researchers are also from the School of Psychiatry, University of New South Wales. Before you decide whether or not you wish to participate in this study, it is important for you to understand why the research is being done and what it will involve. Please take the time to read the following information carefully and discuss it with others if you wish. 1. What is the purpose of this study? The purpose is to explore whether a clinician-guided treatment program can help to reduce anxiety symptoms in a population of mature adults (aged 60-75), when administered over the internet. We also intend to determine how acceptable people find this form of treatment. The study will inform us about how we can best improve future treatment programs for mature adults with anxiety. We have previously completed 20 studies of internet programs for anxiety and depression with more than 1500 participants. Each program comprises of illustrated information about skills and techniques that are common to treating anxiety, homework tasks to facilitate your recovery and regular advice from a clinical psychologist to improve progress. A username (your email address) and password is required for you to access this internet therapy. This study is an open trial comparing the pre- and post-treatment results of a group of 20 participants. We will also enquire about your symptoms 3 months after you complete the treatment program.
2. Why have I been invited to participate in this study? You are eligible to participate in this study because you have reported that you are experiencing anxiety. In order for you to have received this Participant Information Sheet and Consent form you have read information on www.virtualclinic.org.au about the Managing Stress and Anxiety Program and elected to continue with the application process. After you return the consent form you will need to complete the screening questionnaires on our website, and if you are eligible you will then complete a telephone interview with Dr Judy Zou, a Clinical Psychologist, and member of the research team. 3. What if I don t want to take part in this study, or if I want to withdraw later? Participation in this study is voluntary. It is completely up to you whether or not you participate. If you decide not to participate, it will not affect the treatment you receive now or in the future. Whatever your decision, it will not affect your relationship with the staff treating you. New information about the treatment being studied may become available during the course of the study. You will be kept informed of any significant new findings that may affect your willingness to continue in the study. If you wish to withdraw from the study once it has started you can do so at any time without explanation or without contacting us. If you email us that you wish to withdraw, we will confirm the receipt of your email and invite you to complete a short set of optional questionnaires about your symptoms. Your responses to these questionnaires will assist us in providing feedback to you about your symptoms and will help us to advise you about other services that may be of benefit to you. Following this, no further contact with you will occur. 4. What does this study involve? If you agree to participate in this study you will be registered as a patient of St Vincent s Hospital. You will be asked to email us back the Consent Form (as described in the email to which this Information Form is attached). Each time you log on to do a lesson we will take that as a sign of continued consent to participate. We will recruit approximately 20 people to this study. The group will receive access to the online program, including Lessons, Homework Summaries and weekly contact with a Clinical Psychologist from the VirtualClinic (Dr Judy Zou). Each weekly contact will take 5-10 minutes. The treatment program will last up to 8 weeks and over the course of treatment we will measure changes in symptom level. To do this we will ask you to complete 8 questionnaires, which will take around 20-30 minutes to complete. We will measure changes three times throughout the program: 1) before the program, 2) immediately after the program and 3)
three months after the program. We will also measure participation in lessons, homework, activity on the site, and satisfaction with this mode of treatment. The treatment program will be conducted online. As part of the study you will log on to www.virtualclinic.org.au at least every week during the program. Before you start the lessons you will need to complete some questionnaires (as above). Following this, you will read each of the five Lessons. Each lesson provides educational material and homework tasks. Lesson 1: Introduction: Learn about the physical, cognitive and behavioural symptoms of anxiety. Lesson 2: Learn about techniques for managing the thinking (cognitive) symptoms of anxiety. Lesson 3: Learn about techniques for managing the physical symptoms of anxiety. Lesson 4: Learn about techniques for managing the behavioural symptoms of anxiety. Lesson 5: Revise the skills you have learnt. Make a plan for staying well in the future. You will download the homework information and carry out the recommended exercises that aim to give you control over your anxiety. 5. How is this study being paid for? The study is being funded by a research grant from beyondblue, an Australian organisation that provides information about depression and anxiety to consumers, carers and health professionals. The research software developed to run this project (VirtualClinic) is provided by the Clinical Research Unit for Anxiety and Depression, at St Vincent s Hospital, Sydney, and the University of New South Wales. 6. Are there risks to me in taking part in this study? None that are known. If there are difficulties or complications you should contact the clinical psychologist for the study, who will arrange appropriate help. To ensure participant safety, we are asking all participants to provide us with the contact details of their GP. This is so we can contact your GP if we have any concerns for your safety. We will not contact them under any other circumstances. If we do intend to contact your GP we will endeavour to speak with you about this first. Participants who do not experience any improvement of symptoms or worsen by the end of the program or at 3 month follow-up will have their case reviewed by the researchers. These meetings involve the Principal and Associate Investigators and the Clinical Psychologist working with participants. Treatment options will be identified, and the participant will then be telephoned by the Clinical Psychologist to discuss treatment options, and how to access treatment.
7. Will I benefit from the study? Participants with symptoms of anxiety may experience reductions in the severity of their symptoms. However it may or may not directly benefit you. 8. Will taking part in this study cost me anything, and will I be paid? Participation in this study will not cost you anything other than the costs associated with using your computer or accessing the internet. 9. How will my confidentiality be protected? All data concerning your identity, condition and progress will be lodged in our secure electronic database. Of the people treating you, only your clinical psychologist and the VirtualClinic research staff will know whether or not you are participating in this study. Any identifiable information that is collected about you in connection with this study will remain confidential and will be disclosed only with your permission, or except as required by law. Only the researchers will have access to your details which will be held securely at St. Vincent s Hospital. 10. What happens with the results? We will analyse the results of your questionnaires and comments to allow us to improve the program. We plan to publish the results of this study in peer-reviewed journals, presentations at conferences or in other professional forums. In any publication, information will be provided in such a way that you cannot be identified. Results may be discussed with the St Vincent s Hospital Research Ethics Committee for monitoring purposes. Your results may also be used in additional research conducted at the VirtualClinic, for example, combining the results of participants in this study, with those from previous studies. However, additional research with your results will only occur with approval from a Human Research Ethics Committee, and any results will only be reported in such a way that you cannot be identified. 11. What happens to my treatment when the study is finished? You are being offered up to eight weeks of treatment. At the end of the program a clinical psychologist from the VirtualClinic will call you to discuss your progress and make suggestions as to how you might best manage your anxiety in the future.
12. What should I do if I want to discuss this study further before I decide? When you have read this information, you are welcome to contact the researcher, Dr Nickolai Titov. If you would like to know more at any stage, please do not hesitate to contact him on (02) 8382 1406. 13. Who should I contact if I have concerns about the conduct of this study? This study has been approved by St Vincent s Hospital HREC. Any person with concerns or complaints about the conduct of this study should contact the Research Officer, who is nominated to receive complaints from research participants. You should contact them on 02 8382 2075 and quote St Vincent s Hospital file number 10/177. Thank you for taking the time to consider this study. You will be emailed a copy of this information if you consent to participate in this study.