COSTEP 1 Study Interest Form

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To indicate your interest in participating in this study, please fill out this interest form, which takes about 5-10 minutes. This form first describes our study and then asks some questions about your health history, which will help us determine if this study is a good fit for you.

By filling out this form, you agree to have your information stored in a secure online server stored at the University of Minnesota. Your information will not be shared with anyone else other than the team responsible for this study.

This study is called Cognitive Strategies in Early Psychosis 1, or COSTEP 1 for short. The purpose of this research is to learn more about decision making in psychosis spectrum disorders.

In this study, we will ask adults who do not have psychosis to take a single dose of an FDA-approved medication called modafinil. Modafinil is a medication that is used to treat narcolepsy, shift sleep disorder, and obstructive sleep apnea. In this study, modafinil is considered an experimental agent, meaning we are not using it in the same way that the FDA has approved it for.

We're interested to learn how this agent changes how people complete brain games that measure decision making and how it changes brain activity. We measure brain activity through electroencephalography, or EEG. EEG uses a cap with sensors to measure your brain waves. This will improve our understanding of psychosis and help people in the future.

This study involves three study appointments, and a total time commitment of about 6.75-7.5 hours.

Intake and Clinical Research Appointment:
At the first appointment, we would talk about the study in more detail and go through the consent form to see if you are interested in participating. If you agree to participate, we would ask you questions about your life experiences, including your mental health, and have you complete some brain games. This appointment would take about 1.5 hours after signing the consent form.

Health Screening Appointment:
Then, we will ask you to come to an in-person appointment about a week later. The appointment will take place at the MHealth Fairview Riverside Campus in Minneapolis. The appointment will include a blood draw and urine test to make sure it is safe for you to take modafinil and brain games on an iPad. This appointment will last about 45 minutes.

EEG and Study Agent Appointment:

After the Health Screening Appointment, you will come in for your final appointment. First, we will finish the screening measures, which include a breathalyzer and providing a urine sample to test for the presence of alcohol and any illicit drugs, such as cocaine. For your safety, if either test comes back positive for any substance, we would need to reschedule this appointment for another time. If there is a physical possibility that you could be pregnant, we will also conduct a urine pregnancy test.

Then, we will place an EEG cap on your head, which will measure your brain waves. We will ask you to complete brain games on a computer. Next, you will take a single dose of modafinil. We will wait an hour for the drug to fully metabolize. We would take a break and provide you with lunch. After the hour wait is done, you will complete the same brain games you did earlier. This appointment will last about 5 hours.

Check-in Phone Call:

The day after this appointment, study staff will call you to see how you are feeling after taking the medication. This call will take about 10 minutes.

Compensation

You will receive compensation up to $180 for participating in this study:

Intake and Clinical Research Appointment: $35
Health Screening Appointment: $15
EEG and Study Agent Appointment: $70
Total: $120
Plus, you could earn up to $60 in bonuses on the brain games.

Does this sound like something you might be interested in?

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Yes

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By checking this box I agree to answer some questions about my health history and to provide contact information so that the study team can contact me about this study.

Full name (first and last):

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Phone number:

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Email address:

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How old are you?

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What are your pronouns?

Where did you learn about this study?

Is English your primary language?

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Yes

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At what age did you learn English?

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Have you ever been diagnosed with a psychotic spectrum disorder, bipolar disorder, or autism spectrum disorder?

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Yes

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Have any of your immediate relatives (like your parents, siblings, or children) ever been diagnosed with a psychotic spectrum disorder, bipolar disorder, or autism spectrum disorder?

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Yes

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Have you ever had a head injury, like a concussion or TBI?

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Yes

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Describe head injury:

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Did you lose consciousness after the head injury?

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Yes

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How long did you lose consciousness for?

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Did you experience any memory loss of changes in thinking from the head injury?

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Yes

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Do you have any neurological disorders, like multiple sclerosis or MS, ALS, Down Syndrome, Parkinson's disorder, Alzheimer's, or a stroke?

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Yes

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Please describe neurological disorder(s):

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Do you have any major medical issues (i.e., problems with kidneys, liver, heart, or blood)?

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Yes

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Please describe medical problem(s):

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Are you pregnant or breastfeeding, or planning to become pregnant?

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Yes

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Are you currently taking any medications?

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Yes

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Have there been changes to your medications in the past 30 days?

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Yes

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Have you ever had a stimulant use disorder?

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Yes

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Have you been hospitalized for psychiatric reasons in the last 30 days?

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Yes

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Please click "submit."

A member of our study team will be in touch with you in the next couple of days to let you know whether you are eligible to participate to continue in our study. Thank you for your interest in our research!

COSTEP 1 Study team

(612) 403-4585

costep1@umn.edu

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COSTEP 1 Study Interest Form

COSTEP 1 Study Interest Form

Study Description

Contact Information

Demographic and Health History Questions

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