The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
- Conditions
- Treatment Resistant Depression
- Registration Number
- NCT04753385
- Lead Sponsor
- LivaNova
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 138
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
- Willing to comply with Study Watch wearing and recharging requirements
All Subjects
- Any condition or situation the Principal Investigator determines as inappropriate for study inclusion
Phone Application
No additional exclusion criteria for phone application
Study Watch
- Subjects with known severe allergy to nickel or metal jewelry
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
University of Pennsylvania Perelman School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
UT Center of Excellence on Mood Disorders
🇺🇸Houston, Texas, United States
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
ATP Clinical Research, Inc.
🇺🇸Costa Mesa, California, United States
Kind Research Group
🇺🇸Boca Raton, Florida, United States
APG Research, LLC
🇺🇸Orlando, Florida, United States
PsychCare Consultants Research
🇺🇸Saint Louis, Missouri, United States
UT Health Austin
🇺🇸Austin, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Advanced Mental Health Care Inc.
🇺🇸Royal Palm Beach, Florida, United States
Florida Center for TMS
🇺🇸Saint Augustine, Florida, United States
Nova Psychiatry Inc.
🇺🇸Orlando, Florida, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
AMR-Baber Research, Inc.
🇺🇸Naperville, Illinois, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Sheppard Pratt Health Systems
🇺🇸Baltimore, Maryland, United States
Alivation Research, LLC
🇺🇸Lincoln, Nebraska, United States
Michigan Clinical Research Institute PC
🇺🇸Ann Arbor, Michigan, United States
Psychiatric Care and Research
🇺🇸O'Fallon, Missouri, United States
Hapworth Research Inc.
🇺🇸New York, New York, United States
Neuropsychiatric Associates, Plc
🇺🇸Woodstock, Vermont, United States
Scranton Medical Institutes
🇺🇸Moosic, Pennsylvania, United States
North Pointe Psychiatry
🇺🇸Lewisville, Texas, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
Seattle Neuropsychiatric Treatment Center
🇺🇸Bellevue, Washington, United States
Center for Anxiety and Depression
🇺🇸Mercer Island, Washington, United States
Psychiatric Medicine Associates, LLC
🇺🇸Skokie, Illinois, United States
Center for Neuropsychiatry and Brain Stimulation (CNBS)
🇺🇸Cary, North Carolina, United States
OU-SOCM Dept of Psychiatry
🇺🇸Tulsa, Oklahoma, United States
SF-Care, Inc.
🇺🇸San Rafael, California, United States
Beacon Medical Group Behavioral Health
🇺🇸South Bend, Indiana, United States
Augusta University
🇺🇸Augusta, Georgia, United States