Clinical Validation of Samsung Smartwatch

Recruiting

• Conditions: Major Depressive Disorder; Mood Disorders; Mental Health Issue
• Interventions: Device: Wearing Samsung smartwatch and filling out daily surveys

• Registration Number: NCT05767593
• Lead Sponsor: Massachusetts General Hospital

Brief 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 75 individuals diagnosed with current Major Depressive Disorder and 75 healthy controls. To meet this target, the recruitment target is set at 215 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-14
• Study Start: 2023-04-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Depressed Adults	Wearing Samsung smartwatch and filling out daily surveys	Adults with a current diagnosis of Major Depressive Episode
Healthy Controls	Wearing Samsung smartwatch and filling out daily surveys	Adults without a current or past diagnosis of Major Depressive Episode

Primary Outcome Measures

Name	Time	Method
Performance of an index derived from passively collected data in identifying those who have received a diagnosis of Major Depressive Disorder (MDD)	Up to 3-months	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).

Trial Locations

Locations (1)

Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States