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

Study Overview
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Brief Summary
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The objective of this study is to collect both active and passive data using a wearable, multi-sensor device (Verily Study Watch) and phone application (Mood App) which aims to capture mental health status, in subjects participating in the RECOVER clinical trial (A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression).

Detailed Description
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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 that currently own an Android smartphone 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 also 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.

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

Conditions
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Treatment Resistant Depression

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Subjects Current consented subject in the RECOVER clinical trial; 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); Able and willing to provide written informed consent for this sub-study; Able and willing to comply with all study procedures; Able to read and speak English. Phone Application Have a personal Google user account or be willing to create and own a personal Google user account; Owns a personal Android smartphone with a data plan and is the sole user of that smartphone; 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of PHQ-8 tasks | Percentage of PHQ-8 tasks completed over the duration of the study | Through study completion; Average 2 years | 
| Percentage of Voice Diary tasks | Percentage of Voice Diary tasks completed over the duration of the study | Through study completion; Average 2 years | 
| Number of ping sensor recordings | Number of ping sensor recordings over the duration of the study | Through study completion; Average 2 years | 
| Number of hours of watch wear time | Number of hours of watch wear time over the duration of the study | Through study completion; Average 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, TRD