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

Terminated

• 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.

Study Timeline

• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-15
• Study Start: 2021-03-23
• Primary Completion: 2024-09-06
• Study Completion: 2024-09-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Percentage of PHQ-8 tasks	Through study completion; Average 2 years	Percentage of PHQ-8 tasks completed over the duration of the study

Trial Locations

Locations (33)

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

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

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