What is the goal of this study?

The MINDSET Study is designed to determine real-world personal digital health technology (DHT) markers of bipolar disorder including sleep, social activity, lifestyle, stress, routines, and physiology. The eventual aim of this work is to develop tools that individuals with bipolar disorder can use remotely to discover whether patterns in their daily behaviours and habits, emotions and environment are associated with a risk of developing worsening symptoms, or a new mood episode.

The MINDSET study has received ethical approval from the University of Oxford Medical Science Interdivisional Research Ethics Committee (reference: MS IDREC 1553555).

How do I participate?

If you are interested in participating in the MINDSET study, please read the participant information sheet linked here. After reading the information sheet, if you would like to participate, please use this link here to provide your contact information and answer a few pre-screening questions to see if you’re eligible. You will then be contacted by a study team member via email. If you would prefer to speak directly to a member of our study team please contact: MINDSET@4youandme.org.

Who can participate?

First, we are recruiting >1000 participants for a 3-month run-in cohort to identify participants who meet certain eligibility criteria for a main cohort of 250 participants. To be eligible for the run-in cohort, you must:

• Be 18+ years old.
• Have a self-reported diagnosis of bipolar disorder.
• Reside in the UK.
• Be willing to download the study app onto a personally owned iPhone (iOS 16.4 or newer) or Android (OS 6.0 or newer) smartphone.

To be eligible for the main cohort, you must additionally:

• Be willing to use the provided study devices.

• Demonstrate that you are willing to use the study app at least 70% of the time

How long will the study last?

Your participation is completely voluntary and if you are invited to participate in the main cohort, your study participation will last for up to 1 year.

What will I do in the study?

This study is a mix of remote research activities. If you are eligible, you will sign an in app consent form and be contacted by a study team member via email with further information about the study. If you choose to participate and are invited into the Main Cohort, you will be asked to complete the following tasks:

• Use the wearable smart device that will be provided to you that will include an Oura smart ring.
• Participate in bi-weekly check-ins with your study support coordinator that will focus on your study experiences, trouble-shoot app issues, retain feedback on study acceptability and discuss symptom experiences.
• Complete surveys and tasks daily (an average of ~5 minutes per day) in the app when prompted and interact with the study app additional features to log your social activity, lifestyle, stress, routines, and other factors relating to your condition.
• Co-design an app where you are invited to offer continuous feedback on the study app experience.

Those in the run-in cohort will be asked to complete daily and intermittent surveys, and active tasks in the study app.

Will I be compensated for participating in the study?

There is no reimbursement for participation in the study. Participants who are invited into the Main Cohort and complete study will be able to keep the Oura Ring.

Who is conducting this study?

This study is a partnership between the Department of Psychiatry at the University of Oxford (Sponsor, Joint data controller), 4YouandMe (a non-profit organization dedicated to empowering people to better understand their health and increasing the strength of their voices through remote digital health technology), and their coalition partners (AgileOps, Vector Institute for Artificial Intelligence and Cambridge Cognition), Bipolar UK (a national, charitable organization supporting individuals who have bipolar disorder and is responsible for co-designing participant outreach materials and for the recruitment of participants through Bipolar UKs membership community) and Dementias Platform UK (DPUK; a UK based, secure, research environment).

Do you have further information for me to read?

Yes! Here is the link to the MINDSET Study Frequently Asked Questions linked here. If you would prefer to speak directly to a member of our study team, please contact: MINDSET@4youandme.org