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

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).

Study Overview

• Status: Terminated
• Conditions: Treatment Resistant Depression

Detailed Description

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 (Actual): 138

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research, Inc.
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC
    • San Rafael, California, United States, 94901
      • SF-CARE, Inc.
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Kind Research Group
    • Orlando, Florida, United States, 32803
      • Apg Research, Llc
    • Orlando, Florida, United States, 32803
      • Nova Psychiatry Inc.
    • Royal Palm Beach, Florida, United States, 33411
      • Advanced Mental Health Care Inc.
    • Saint Augustine, Florida, United States, 94901
      • Florida Center for TMS
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Illinois
    • Naperville, Illinois, United States, 60563
      • AMR-Baber Research, Inc.
    • Skokie, Illinois, United States, 60076
      • Psychiatric Medicine Associates, LLC
    • Springfield, Illinois, United States, 62794
      • Southern Illinois University School of Medicine
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Beacon Medical Group Behavioral Health
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Sheppard Pratt Health Systems
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Michigan Clinical Research Institute PC
  • Missouri
    • O'Fallon, Missouri, United States, 633668
      • Psychiatric Care and Research
    • Saint Louis, Missouri, United States, 63128
      • PsychCare Consultants Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research, LLC
  • New York
    • New York, New York, United States, 10019
      • Hapworth Research Inc.
  • North Carolina
    • Cary, North Carolina, United States, 27519
      • Center for Neuropsychiatry and Brain Stimulation (CNBS)
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • OU-SOCM Dept of Psychiatry
  • Pennsylvania
    • Moosic, Pennsylvania, United States, 18507
      • Scranton Medical Institutes
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • University of Pennsylvania Perelman School of Medicine
  • Texas
    • Austin, Texas, United States, 78712
      • UT Health Austin
    • Houston, Texas, United States, 77054
      • UT Center of Excellence on Mood Disorders
    • Lewisville, Texas, United States, 75057
      • North Pointe Psychiatry
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Neuropsychiatric Associates, Plc
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic
  • Washington
    • Bellevue, Washington, United States, 98004
      • Seattle Neuropsychiatric Treatment Center
    • Mercer Island, Washington, United States, 98040
      • Center For Anxiety and Depression

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LivaNova
• Investigators: Principal Investigator: Charles Conway, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Actual): September 6, 2024
• Study Completion (Actual): September 6, 2024

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Depression; TRD
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Depression; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: LND300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No