Treatment Resistant Depression
Conditions
Keywords
Depression, TRD
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.
Interventions
None listed
Sponsors
LivaNova
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed