The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes (UNCOVER)
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ClinicalTrials.gov Identifier: NCT04753385 |
Recruitment Status :
Active, not recruiting
First Posted : February 15, 2021
Last Update Posted : May 16, 2024
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Condition or disease |
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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 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.
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes |
Actual Study Start Date : | March 23, 2021 |
Estimated Primary Completion Date : | October 2024 |
Estimated Study Completion Date : | October 2024 |
- Percentage of PHQ-8 tasks [ Time Frame: Through study completion; Average 2 years ]Percentage of PHQ-8 tasks completed over the duration of the study
- Percentage of Voice Diary tasks [ Time Frame: Through study completion; Average 2 years ]Percentage of Voice Diary tasks completed over the duration of the study
- Number of ping sensor recordings [ Time Frame: Through study completion; Average 2 years ]Number of ping sensor recordings over the duration of the study
- Number of hours of watch wear time [ Time Frame: Through study completion; Average 2 years ]Number of hours of watch wear time over the duration of the study
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
This sub-study is only open to sites participating in the RECOVER clinical study.
Every subject that currently owns an Android smartphone will be offered to opt-in to the sub-study.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04753385
Principal Investigator: | Charles Conway, MD | Washington University School of Medicine |
Responsible Party: | LivaNova |
ClinicalTrials.gov Identifier: | NCT04753385 |
Other Study ID Numbers: |
LND300 |
First Posted: | February 15, 2021 Key Record Dates |
Last Update Posted: | May 16, 2024 |
Last Verified: | May 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Depression TRD |
Depression Depressive Disorder, Treatment-Resistant Behavioral Symptoms |
Depressive Disorder Mood Disorders Mental Disorders |