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NCT05767593

Clinical Validation of Samsung Smartwatch

Active, enrolled Last updated 17 April 2026
What this trial tests

trial testing Wearing Samsung smartwatch and filling out daily surveys in Major Depressive Disorder in 220 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
27 April 2023
Primary endpoint
1 December 2026
1 January 2027

Quick facts

Lead sponsorMassachusetts General Hospital
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment220
Start date27 April 2023
Primary completion1 December 2026
Estimated completion1 January 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder or Mood Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

Other Massachusetts General Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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