Frequently Asked Questions
General Study Questions
What is the purpose of this study?
The purpose of this research study is to learn how we can improve current treatment to help manage mental health. There are two main focuses for this project. First, we are studying how certain smartphone apps can improve mental health. Second, we are studying people’s behaviors, genes, and health information to understand how to match people with the type of mental health care that will be the most helpful for future treatments.
Who can take part in this study?
Adult patients (age 18+) who have a scheduled adult mental health intake appointment at either Michigan Medicine Outpatient Psychiatry or University Health Service and have daily access to a smartphone are eligible to participate in this study.
What will happen to me if I participate in this study?
If you agree to participate in this study, we will ask you to complete one initial (baseline) survey, three follow-up surveys, and a daily mood rating, all via the MyDataHelps study app.
We will provide you with a free Fitbit and ask you to sync with your smartphone and wear every day throughout the study - this will allow us to collect data on your daily activity, such as steps, sleep, and heart rate.
During the study app set-up, you will be prompted to allow the MyDataHelps to send you daily notifications to enter your daily mood rating. A notification will be automatically generated on your phone and will appear similar to the following: “On a scale of 1 to 10, what was your average mood today?” You will then respond in the app. You will also receive similar notifications for your three follow-up surveys, which will occur at 6-weeks, 18-weeks, and 1-year after enrollment in the study.
Lastly, you will also be asked to contribute a DNA saliva sample to the University of Michigan Central Biorepository. This DNA sample will help us draw connections between health conditions, responses to treatment, and genetics.The results of your DNA analysis will not be used as a part of your regular medical treatment, and results will not be returned to you or your clinician(s).
How will this study affect my medical care?
Participation in this study is in no way connected to your medical care, nor is it a part of any medical treatment. Choosing to participate or not participate in this study will not affect the type or quality of medical care you receive at the University of Michigan or any other healthcare provider. However, we are hoping that the findings of this study contribute to improved and more personalized medical care, especially mental healthcare, in the future.
What is the time commitment for participating in this study?
Your participation will require approximately 25-40 minutes to complete the initial survey, set up your study app and Fitbit or Apple Watch, and provide a DNA sample. The mood rating will require less than one minute each day. Each of the three follow-up surveys (at 6-weeks, 18-weeks, and 1-year, respectively) will require approximately 20 minutes to complete. If you are randomized to a group receiving access to a mental health app, your engagement time may vary depending on the program and your desire for utilization (e.g., 5-60 minutes weekly). We may send you reminders via email, text message, phone, or mail to complete the surveys, submit a DNA sample, regularly wear your Fitbit, or submit daily mood ratings.
What measures are taken to protect my private/protected health information?
Your survey data and all other information collected through your phone, as well as your DNA sample, will be coded with a unique identifier so that all information provided by you will remain confidential. All identifying information will be stored and secured separately from your survey, phone data, and DNA sample, and will only be accessible to essential study personnel. All data is transferred directly from your phone and stored in a secure and HIPAA-compliant environment.
Who will have access to my private/protected health information?
Only essential study personnel will have access to your private, protected health information, which will also be stripped of identifiers and labeled with a unique, random code to protect your identity and personal information.
When will my participation in the study be over?
Your active participation in the study will last approximately one year. In addition to your active participation, we will collect information from your medical records for up to another five years after your active participation ends. However, any participant is free to leave the study at any time, without penalty or negative impact on medical care received at the University of Michigan.
If I want to stop participating in the study, what should I do?
You are free to leave the study at any time. If you leave the study before it is finished, there will be no penalty to you, nor will there be any impact on the medical care received at the University of Michigan. You will not lose any benefits to which you may otherwise be entitled (such as compensation for surveys you have already completed). If you choose to tell the researchers why you are leaving the study, you reasons for leaving may be kept as a part of the study record. If you would like to leave/end your participation in the study, please contact us at your next convenience.
How many people are expected to take part in this study?
We are expecting about 4,500 subjects to participate in the PROMPT study, with approximately 2,250 from Michigan Medicine Outpatient Psychiatry and 2,250 from University Health Service.
If I take part in this study, can I also participate in other studies?
Being in more than one research study at the same time, or even at different times, may increase the risks to you. It may also affect the results of the studies. You should not take part in more than one study without approval from the researchers involved in each study.
Who will pay for the costs of the study? Will I or my health plan be billed for any costs of the study? There are no costs or billing for this study. There may be an indirect cost to participate in this study because some of the data collected for this study and transmitted to the study team will need to be covered by your smartphone’s data plan. By signing this form, you do not give up your right to seek payment if you are harmed as a result of being in this study.
App/Technology Questions
I'm having an issue with the MyDataHelps App:
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I can't get Apple Health to sync with the MyDataHelps app
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To sync Apple Health to the MyDataHelps app, open the Health app on your iPhone.
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Next, select the tab in the bottom center of the screen that says "Sharing"
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Select the "Apps" option near the bottom of the screen
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Finally, select "MyDataHelps" from the list of options and make sure all categories are turned "on,"
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If MyDataHelps is not an option on this list, make sure that the MyDataHelps app is downloaded to your iPhone
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Now Apple Health and the MyDataHelps app should be connected!
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I'm having an issue with the Fitbit app:
Try using this webpage to address your issue, if you are still having problems, please feel free to contact the study team directly for more personalized assistance.
I'm having an issue with pairing my Fitbit and my app/mobile device.
Try using this webpage or look at the "Fitbit Setup" page on this site (under the "Getting Started" tab) to address your issue. If you are still having problems, please feel free to contact the study team directly for more personalized assistance.
I'm having an issue with my Fitbit device.
Try using this webpage to address your issue, if you are still having problems, please feel free to contact the study team directly for more personalized assistance.
I'm having an issue with the Headspace app.
Try using this webpage to address your issue, if you are still having problems, please feel free to contact the study team directly for more personalized assistance.
Do I have to allow notifications from these apps?
We ask that all study participants allow study apps to send push notifications. These notifications will help you remember to consistently enter your daily mood ratings, submit your surveys on-time, and give you feedback based on your activity level, sleep quality, and mood ratings. It is important for the study that participants consistently complete daily tasks, and these notifications can help ensure this.
How do I update my daily mood rating in MyDataHelps?
To update your average daily mood rating in MyDataHelps:
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Open the app and select the "Dashboard" tile on the bottom of the screen.
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Scroll down to the "Mood Ratings" section.
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Select the "Update Today's Mood Rating" under the mood rating graph.
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Enter your new average mood score for the day. Note that you can only update today's mood rating, and not ratings from previous days.
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Scroll Down
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Enter your new mood rating here
DNA Donation/University of Michigan Central Biorepository Questions
Do I have to give a DNA sample to participate in PROMPT?
At this time, providing a DNA saliva sample to the PROMPT Study team is an optional aspect of participation. If you decide you are not comfortable with producing the sample or any of the possible uses for or storage of your DNA, you may choose to not return the saliva sample.
Will I be able to see the results of my DNA analysis?
Neither participants nor their healthcare providers will be contacted about or be able to view any results of DNA analyses that are conducted within the University of Michigan Central Biorepository. The DNA analysis as part of this study is not related to your medical care. For more information about the Central Biorepository, look over the Central Biorepository Consent page.
How long will my DNA sample last? How soon do I need to return the sample? Will my sample be in storage forever?
While DNA is stable at room temperature for 2-4 weeks, we ask that you return your saliva sample in the included mailer as soon as possible once you finish producing the sample. However, if you would prefer to produce your sample in person the next time you are at the Rachel Upjohn Building or University Health Service, you are welcome to drop off your tube/kit at one of these locations. Further, once submitted, your sample will remain in the Central Biorepository indefinitely, unless you choose to withdraw from the study at which point it will be destroyed immediately.
Can I eat or drink before producing my saliva sample?
We ask that you avoid eating or drinking anything other than water for 30 minutes before producing your saliva sample (to ensure the sample's purity).
How could my DNA be used?
Once entered into the University of Michigan Central Biorepository, your DNA could be made available for researchers within or outside of the University of Michigan for research studies. Researchers interested in gaining access to the collection must submit an application to the Precision Health program through the Data Office for Clinical & Translational Research (DOCTR). The Precision Health MGI Access oversight committee will review requests for access to biospecimen data and determine whether they meet the standards of the Governing University of Michigan Medical School (UMMS) Research Biorepositories Policy. IRB approval is required before any request for access to individual-level MGI resources is fulfilled. When we ask for your consent to participate in this study and to donate a sample to the biorepository, this also gives your consent for approved researchers to use your DNA for research projects that may come up in the future. While we don’t know in advance what specific projects your DNA analysis/results will be used for, some examples of possible kinds of projects that could use your DNA include exploring health effects of environment and lifestyle, creating stem cells that can turn into other cells, studying how genes affect the way medicines work, creating cells that live forever, learning how to target cures to specific diseases, including those unrelated to your condition, and using your materials in research using animals. For more detailed information, please visit the Central Biorepository Consent page, or contact the study team.