Who is eligible for participation in this study?

We are currently recruiting people who meet the following requirements:

• Between the ages of 14 and 19

• Bipolar disorder group: A diagnosis of a bipolar spectrum disorder (bipolar I, bipolar II, other specified bipolar disorder)

• Typically-developing group: No current psychiatric disorder, no lifetime mood/psychotic disorder diagnosis, no family history of bipolar disorder

• Note - Final eligibility will be determined based on a brief screening interview and in-person diagnostic evaluation

 

Who is not eligible for participation in this study?

We cannot include people who:

• Do overnight shift work

• Have a significant physical disability (i.e., in wheelchair, otherwise immobile)

• Meet study criteria for a neurodevelopmental disorder and/or intellectual disability (IQ<75), including autism spectrum disorder

• Have a current  diagnosis likely to affect ability to participate, including substance dependence, conduct disorder, suicidal ideation with current plan

• Do not use a smartphone

 

What will be expected of me if I participate?

• People who are eligible will be invited, with a caregiver, for a baseline assessment

• The baseline assessment will take place at NYU Langone Health (One Park Avenue) in New York City or virtually. It will take between 2 and 3 hours

• At the baseline appointment, eligible participants will have an app installed on their smartphone. The app will collect information from their phone about their activity. It will also send a 6-question survey twice a week, and ask participants to record a brief voice memo once a week. The app requires participants to connect to a wifi network once a day to upload data

• Following the baseline appointment, participants and their caregivers will be interviewed by phone once a month, and will be asked to complete a brief, online survey once a month. This will happen for 18 months, participants and caregivers will be paid for completing the interviews and surveys

• At the completion of the 18 months, participants and caregivers will return for a final appointment either in-person or virtually

 

Will I be compensated for my participation in the study?

Yes. You can earn over $600 and your caregiver can earn $250. The payment schedule is as follows:

• Baseline appointment (participant) - $60

• Baseline appointment (caregiver) - $40

• Monthly phone interview/survey (participant) - $10

• Monthly compliance bonus (participant) - $0.50/day that data are uploaded, up to $15.50 per month for perfect compliance

• Monthly phone interview/survey (caregiver) - $10

• Final appointment (participant) - $100

• Final appointment (caregiver) - $40

 

What specific data are you collecting?

The app will passively be collecting information from your phone's accelerometer, GPS, phone/screen usage, phone and text message call log.

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What will be done with my data?

We plan to use sophisticated mathematical models to look for patterns in the data that change when mood symptoms appear. These models rely on a technique known as machine learning, which can be used to classify data from different periods as being during or not during a mood episode. This will help us understand what characteristics to look for in the future when we try to predict mood changes based on people’s smartphone data.

 

Other risks or benefits

We don’t anticipate any significant risks to participants. The study activities do not require you to do anything unusual or substantially different from normal activities. The main risk is likely to be discomfort during the interview portions of the study, when you will be asked to answer questions about mental health, which may be sensitive. The risk of discomfort will be minimized by doing what we can to ensure privacy.

 

Some people might also be uncomfortable with the idea that their digital data are being collected. These data will be stored with an ID code, not with a name, and will be encrypted and password-protected to minimize the risk of identification.

 

We hope that this study will lead to significant benefits in the future - our goal is to be able to predict the onset of new mood episodes in young people with bipolar disorder, so that preventive interventions can be administered. We hope this will help improve the quality of life for many young people affected by bipolar disorder.

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How will this study protect my privacy?

The privacy of your data is a priority for us.

All data will be identified only by an ID number. Your name will not be attached to your data at any time. Additionally, all survey and phone data will be collected using secure methods and will not be accessible to anyone outside of the research team.

 

We rely on dedicated people to do this research. Thank you in advance for your contribution to science and to our understanding of mood symptoms in adolescents!