The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes

A prospective, observational, exploratory study collecting passive and active behavioral, environmental and physiological data, via the use of an Android smartphone application and Study Watch.

This sub-study is only open to sites participating in the RECOVER clinical study.

All subjects participating in the RECOVER clinical trial at active UNCOVER sites will be offered participation in this sub-study.

Subjects who opt-in to the Mood App portion of the sub-study will be followed for a minimum of 12 months and a maximum of 60 months for the Mood App portion of the sub-study.

Subjects who opt-in to the use of the Study Watch portion of the sub-study will be followed for a minimum of 12 months and maximum of 24 months for the Study Watch portion of the sub-study.

Primary outcomes

• Percentage of PHQ-8 tasks [Through study completion; Average 2 years]: Percentage of PHQ-8 tasks completed over the duration of the study
• Percentage of Voice Diary tasks [Through study completion; Average 2 years]: Percentage of Voice Diary tasks completed over the duration of the study
• Number of ping sensor recordings [Through study completion; Average 2 years]: Number of ping sensor recordings over the duration of the study
• Number of hours of watch wear time [Through study completion; Average 2 years]: Number of hours of watch wear time over the duration of the study

Sex: All, ages: 18 Years to any

Inclusion Criteria:

All Subjects

1. Current consented subject in the RECOVER clinical trial;
2. Adult (i.e. ≥ 18 years of age, unless a resident of any U.S. state where the age of majority is 19, in which case must be ≥ 19 years of age);
3. Able and willing to provide written informed consent for this sub-study;
4. Able and willing to comply with all study procedures;
5. Able to read and speak English.

Phone Application

1. Have a personal Google user account or be willing to create and own a personal Google user account;
2. Owns a personal Android smartphone with a data plan and is the sole user of that smartphone;
3. Agrees to download and maintain the phone application onto personal Android smartphone for the duration of the sub-study;

Study Watch

1\. Willing to comply with Study Watch wearing and recharging requirements

Exclusion Criteria:

All Subjects

1\. Any condition or situation the Principal Investigator determines as inappropriate for study inclusion

Phone Application

No additional exclusion criteria for phone application

Study Watch

1\. Subjects with known severe allergy to nickel or metal jewelry

• Charles Conway, MD, Principal investigator, Washington University School of Medicine