PLAIN LANGUAGE STATEMENT AND CONSENT FORM
Plain Language Statement
Date: 11th May, 2015
Full Project Title: Brief online intervention to improve depressive symptoms
Principal Researcher: Dr. Matthew Fuller-Tyszkiewicz
Dear prospective participant,
You are invited to take part in this research project. This Plain Language Statement 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 so that you can make a fully informed decision regarding whether or not you wish to participate. Please read this Plain Language Statement carefully. By continuing to the questionnaire on the next page, you give your consent to participate in the research project. You can, however, withdraw your participation at any time if you wish.
Depression is common in the general population, affecting up to 45% of people at some point in their lives. Many individuals who do not qualify for a clinical diagnosis of depression may still experience depressed mood in their daily lives.
The purpose of this study is to trial a free, innovative online intervention to improve depressive symptoms. The intervention teaches individuals relaxation techniques, ways to focus on positive thoughts when they experience negative thoughts, and provides general educational information about the characteristics and common causes of depression.
A total of 120 men and women will participate in this study. You are invited to participate in this research project because we wish to obtain data from a sample of men and women aged 18 to 40 years.
For this research you will be require to download an iPhone application. There are several aspects to this research. First, participants complete a baseline questionnaire which asks about demographic information (e.g., your age, height, and weight, treatment history), depressive symptoms, and psychological wellbeing. This baseline questionnaire will take 15 minutes to complete. Those allocated to the intervention group will have access to the web intervention during this 21 day period, and will be asked to use the resources as often as they desire (although we recommend at least 5 minutes per day). Those in the control group will have access to the web resources after 21 days. At the 21 day mark, all participants (control and intervention groups) will complete the baseline questionnaire again, and will do so one last time 3 weeks after that (i.e., 6 weeks after the start of the study) in order to allow us to evaluate change in depressive symptoms over time.
Overall, total participation time is approximately 1-3 hours (1 hour for control group participants and up to 3 hours for the intervention group) over the course of six weeks.
Access to, and use of, the web resources are expected to improve depressive symptoms for you. Moreover, these techniques may be useful for other negative thoughts (or low mood experiences) in your life, and may thus be more useful than just for depressive symptoms. Should the intervention prove effective, we will make this available to the general population for free. You will be able to access the resources beyond the duration of participation in the study.
There are no anticipated risks outside the normal day-to-day activities. However, given that the questionnaires will include questions regarding issues such as depressed mood, there is a slight possibility that you may experience some concern about your responses. If you do participate and find that you are uncomfortable or overly worried about your responses to any of the questionnaire items, or if you find participation in the project distressing, you should contact Dr Matthew Fuller-Tyszkiewicz, the Principal Investigator. You may also like to contact a government or community organisation specialising in dealing with distress. You can contact your GP. Alternatively, for a free services, contact Lifeline on 13 11 14 or visit www.mycompass.org.au, a website which provides reputable psychoeducation, allows you to monitor your symptoms, and provides a range of techniques to alleviate depressed mood. Importantly, MyCompass is freely available and has been shown to improve symptoms.
Should the intervention prove effective, we will make this available to the general population for free.
To preserve your anonymity, we ask you NOT to place your name, or any identifying information anywhere on the survey. Your contact details have not been obtained, nor will they be, at any point. Thus, none of the information you provide can in any way be linked back to you. Upon submission, your responses will be entered electronically into a secure server at Deakin University, from which only group data will be reported or published. This database is password protected and managed within the guidelines applicable to the secure storage of all electronic data within Deakin University. Only the principal researcher will have access to this grouped data.
The project will not only be monitored by Dr Matthew Fuller-Tyszkiewicz, the supervisor on the project, but also by the Deakin University School of Psychology, to ensure the research practices comply with Deakin University ethics guidelines.
There is no payment for participation. However, participants who have completed our app-based studies in the past have found the experience enjoyable and awareness raising.
This project is being funded by the Deakin University School of Psychology.
The research team have no declarations of interest to report.
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. However, as the information is de-identified, we will not be able to retrieve and remove the data prior to analyses. Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your relationship with Deakin University in any way.
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.
Should you have any concerns or questions about this research project, please contact the Principal Research, Dr. Matthew Fuller-Tyszkiewicz. Should you wish to contact Dr Fuller-Tyszkiewicz, you may reach him on the following details;
Dr Matthew Fuller-Tyszkiewicz
Deakin University, School of psychology
Phone: (03) 9251 7344
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:
The Manager, Research Integrity, Deakin University, 221 Burwood Highway, Burwood Victoria 3125, Telephone: 9251 7129, email@example.com
Please quote project number [2015-009].