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NCT05767593 · ClinicalTrials.gov registry record
Clinical Validation of Samsung Smartwatch
A clinical trial of Major Depressive Disorder and Mental Health Issue, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- 220
- Enrollment target
- 1
- Study location
NCT05767593: Recruiting study of Major Depressive Disorder and Mental Health Issue, sponsored by Massachusetts General Hospital.
NCT05767593 is a study of Major Depressive Disorder and Mental Health Issue that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 220 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05767593, a study of Major Depressive Disorder and Mental Health Issue, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- 220 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective: Wearable technology holds promising potential for mental health monitoring and detection. Samsung has developed an algorithm that they believe can detect signs of depression and anxiety in smartwatch users. They have used this algorithm to create a "Mindfulness Index," which is an easily understood visual index of mental health. The primary aim of the study is to evaluate the performance of Samsung's Mindfulness Index in identifying those who have received a diagnosis of Major Depressive Disorder (MDD) from a clinician-administered semi-structured diagnostic interview. Research Procedures: The target sample size is 135 individuals diagnosed with current Major Depressive Disorder and 85 healthy controls. To meet this target, the recruitment target is set at 220 participants. Participants will be assigned to the MDD condition, or the healthy control condition based on their score on the Beck Depression Inventory. Each subject will be followed for 3 months. Participants will be provided with a Samsung smartphone and Samsung smartwatch. Participants will be asked to wear the smartwatch 24 hours per day, except while charging. This smartwatch will collect data on heartrate, sleep time, and step count. During the study, each day participants will receive texts prompting a link to a "daily diary." These surveys will ask about depression and anxiety symptoms. Additionally, during the first 3 weeks of the study, participants will participate in ecological momentary assessment; texts will be sent 5 times per day prompting participants to fill out a survey about how they currently feel in that moment. These extra surveys will stop after the first 3 weeks of the study, but the daily diary surveys will continue throughout the study. Furthermore, virtual clinician visits will occur at weeks 4, 8, and 12.
Primary Outcome
Area under the Receiver-Operating Characteristic curve (AUC) for an index derived from up to 3-months of passively-collected data from a smartwatch device in identifying those diagnosed with major depressive disorder (as assessed by MINI or DIAMOND Diagnostic Interview).
Conditions Studied
Interventions
- DEVICE Wearing Samsung smartwatch and filling out daily surveys
Study Locations (1)
Massachusetts
- Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2023-04-27 |
| Est. Completion | 2027-01-01 |
What NCT05767593 shows while recruiting
NCT05767593 is an observational study that tracks outcomes without assigning an intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (41% lower).
The record links to 3 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Wearing Samsung smartwatch and filling out daily surveys is the first listed.
NCT05767593 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05767593 about?
NCT05767593 is a clinical study titled "Clinical Validation of Samsung Smartwatch". Objective: Wearable technology holds promising potential for mental health monitoring and detection. Samsung has developed an algorithm that they believe can detect signs of depression and anxiety in smartwatch users. They have used this algorithm to create a "Mindfulness Index," which is an easily...
What is the current status of trial NCT05767593?
This trial is currently recruiting. The enrollment target is 220 participants. The study started on 2023-04-27. Estimated completion is 2027-01-01.
What conditions does trial NCT05767593 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Mental Health Issue, Mood Disorders.
What interventions are being tested in trial NCT05767593?
The interventions under investigation include: Wearing Samsung smartwatch and filling out daily surveys (DEVICE).
Who is sponsoring clinical trial NCT05767593?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05767593 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05767593's enrollment target sits among peer trials
220 69th of 282 higher than 213 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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