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).
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.
Study Type
OBSERVATIONAL
Enrollment
138
University of Alabama at Birmingham
Birmingham, Alabama, United States
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Keck Hospital of USC
Los Angeles, California, United States
SF-Care, Inc.
San Rafael, California, United States
Kind Research Group
Boca Raton, Florida, United States
Percentage of PHQ-8 tasks
Percentage of PHQ-8 tasks completed over the duration of the study
Time frame: Through study completion; Average 2 years
Percentage of Voice Diary tasks
Percentage of Voice Diary tasks completed over the duration of the study
Time frame: Through study completion; Average 2 years
Number of ping sensor recordings
Number of ping sensor recordings over the duration of the study
Time frame: 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
Time frame: Through study completion; Average 2 years
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APG Research, LLC
Orlando, Florida, United States
Nova Psychiatry Inc.
Orlando, Florida, United States
Advanced Mental Health Care Inc.
Royal Palm Beach, Florida, United States
Florida Center for TMS
Saint Augustine, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
...and 23 more locations