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Clinical Validation of Samsung Smartwatch

NCT05767593 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2026-04-17

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Wearing Samsung smartwatch and filling out daily surveys

Participants will wear a Samsung smartwatch and fill out daily surveys about their mood and depressive symptoms.

Sponsors & Collaborators

Principal Investigators

  • Amanda Baker, PhD · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-27
Primary Completion
2026-12-01
Completion
2027-01-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05767593 on ClinicalTrials.gov