PLAIN LANGUAGE STATEMENT AND CONSENT FORM
Plain Language Statement
Full Project Title: Evaluating a smartphone-based intervention to reduce depressive symptoms
Principal Researchers: Dr. Matthew Fuller-Tyszkiewicz, Dr Ben Richardson, Professor Helen Skouteris, Associate Professor David Austin
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.
Depressed mood is common among men and women in the general population, affecting roughly 1 in 5 people in their lifetime, and 18-25 years of age seems to be a peak period for onset of symptoms. Importantly, research suggests that detecting and treating symptoms early provides greater outcomes for people in terms of speed of recovery and preventing the development of more serious and long-term depressive symptoms and related health outcomes. Therefore, development and dissemination of effective treatments for depression are urgently needed to reduce the incidence and course of depression in the general population.
Prior research shows that internet or phone based interventions are typically as effective as face-to-face interventions, and are viewed positively by users because they are easy to use, freely available, and allow for anonymity that is not possible when seeing a clinician in-person. However, it remains unclear exactly how long individuals should undertake these web and phone-based interventions for, and at exactly what time point during treatment individuals should complete the intervention exercises. Therefore, the aim of the present study is to evaluate an innovative treatment for depression that will be administered entirely via a smartphone app. We will monitor symptoms of depression and associated variables (e.g., physical exercise, social interaction, sleep quality, level of stress, etc.) over the course of treatment to see how long it takes for depressive symptoms to improve, and whether some of the intervention modules are better than others for reducing symptoms quickly and effectively.
A total of 600 people will participate in this study. Four hundred participants will be randomly allocated to the treatment conditions, in which they are invited to download and use the intervention app (BlueWatch) for a period of 12 weeks. We will follow these participants with surveys at baseline, 12 weeks, as well as at later follow-up points to see how they are tracking. The remaining two hundred participants will be allocated to a waitlist control condition for 12 weeks, where they will be asked to monitor their mood several times each day. This app will also provide the participant with feedback about their mood over the days and weeks. After the 12-week period, waitlist control participants will be given access to BlueWatch.
You are invited to participate in this research project because we wish to obtain data from a sample of males and females aged 18 to 25 years.
For this research you will be required to download a smartphone application (iPhone only). There are three phases to this research. Phase 1 involves completing a brief screening tool online that will take 15-20 minutes to complete. This screening tool evaluates whether participants qualify for participation based on whether they have at least mild to moderate depressive symptoms. Those who qualify will then receive a phone interview from a member of our team who will confirm symptoms and walk you through the rest of the steps of the study. Phase 2, as the team member will inform you, involves downloading our intervention application on your phone, and participating in the intervention. This intervention content consists of 12 weeks of 30-minute modules that cover education about depression, as well as offering techniques to reduce depressive symptoms (such as addressing negative thoughts, breathing exercises to reduce stress, and learning about other coping strategies that are effective). During these 12 weeks of intervention, brief 1-2 minute mood surveys will signal up to 4 times per day to chart the progress of your mood across the intervention phase. The app has a feedback function so that you can chart your mood progress! At the end of the 12 weeks, you will be asked to complete the depression screening tool and quality of life measure (10 minutes to complete) again to see change in symptoms. Finally, in Phase 3 (6 months post-intervention), we will ask you to complete the screening survey and quality of life measure (10 minutes total) again to see whether reduction in depressive symptoms have been maintained long-term.
Overall, total participation time is approximately 5 hours over the course of 12 weeks (+ the 6 month follow up).
- Risks and potential benefits to participants;
The intervention content is based on materials that have been shown to significantly reduce depressive symptoms in previous research. Therefore, the key anticipated benefit for participants is expected improvement in symptoms. The app (whether in the waitlist control group or intervention) has a feedback function that allows you to chart changes in your mood across days and weeks, and you may find this exercise informative about how often your mood changes, and the sorts of events that improve your mood. Past research suggests that participants find this summary information useful for better understanding their mood states.
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. For instance, you can contact your GP or, alternatively, for a free service, contact Lifeline on 13 11 14.
Benefits to the wider community;
Research findings will help to establish the efficacy of our intervention and, once established, this smartphone app would be made freely available for the general population. This in turn may contribute to helping others with mental illness.
- Privacy and confidentiality;
Initially, your scores on the baseline screening survey will be linked with your contact details (phone number or email address) as we need to contact you to instruct in download of the app. However, your identifying information will be removed from the baseline survey file at the completion of your participation in the study, and replaced by an alpha-numeric code used to de-identify your data. Hence, from that point on, 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 researchers will have access to this grouped data.
· Form of dissemination of the research results;
- A summary of the findings will be available for any interested participants to read at the completion of the study. Findings may be published in peer-review journals and may be used as part of conference presentations. However, all results in these journals and presentations will be presented at the group level to ensure anonymity for participants. Please contact firstname.lastname@example.org if you would like to receive a copy of this report or be forwarded details of where to find the publications.
- How the research will be monitored;
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.
- Any payments to participants;
There is no payment incentive for participating.
- Funding for the research;
This project is being funded by the Deakin University School of Psychology and Rotary Mental Health grant.
- Financial or other relevant declarations of interests of researchers, sponsors and institutions;
The research team has no declarations of interest to report.
- 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. However, as the information is de-identified once you download and start to use the smartphone app, 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.
· Further Information;
Should you have any concerns or questions about this research project, please contact the Principal Researcher, Dr Matthew Fuller-Tyszkiewicz or Dr Linda Hartley-Clark. Should you wish to contact Dr Fuller-Tyszkiewicz or Dr Linda Hartley-Clark, you may reach them with the following details:
Dr Matthew Fuller-Tyszkiewicz
Deakin University, School of psychology
Phone: (03) 9251 7344
Dr Linda Hartley-Clark
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 [2014-272].