Clinical Validation of Samsung Smartwatch

NCT05767593 | Active Not Recruiting

• 1 other identifier: 2022P002104
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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 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

Major Depressive Disorder; Mood Disorders; Mental Health Issue

Keywords

Wearable technology; Smartwatch

Outcome Measures

Primary Outcomes (1)

• Performance of an index derived from passively collected data in identifying those who have received a diagnosis of Major Depressive Disorder (MDD)

  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).

  Up to 3-months

Study Arms (2)

Depressed Adults

Adults with a current diagnosis of Major Depressive Episode

Device: Wearing Samsung smartwatch and filling out daily surveys

Healthy Controls

Adults without a current or past diagnosis of Major Depressive Episode

Device: Wearing Samsung smartwatch and filling out daily surveys

Interventions

Wearing Samsung smartwatch and filling out daily surveys DEVICE

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

Depressed Adults; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

U.S. residents recruited through online advertisements.

You may qualify if:

• Age 18-65
• Meet full DSM-5 diagnostic criteria for a current major depressive episode, as assessed by the MINI for DSM-5 or Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) AND exhibit both:
• Beck Depression Inventory score of 9 or higher.
• Clinical Global Impressions Scale of 3 or higher.
• If the patient is receiving psychopharmacological or psychosocial treatment, must be stable for 8 weeks prior to enrollment.
• Age 18-65
• Do not meet the criteria for current or past major depressive episodes according to the DSM-5 criteria AND exhibit both:
• Beck Depression Inventory score of 8 or lower.
• Clinical Global Impressions Scale of 2 or lower.
• If the patient is receiving psychopharmacological or psychosocial treatment, must be stable for 8 weeks prior to enrollment.

You may not qualify if:

• A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; an eating disorder in the past 6 months; organic brain syndrome; a history of substance use disorder in the last 12 months.
• Presence or history of clinically significant neurological disorders and brain injuries (cerebral infarction, cerebral hemorrhage, multiple sclerosis, epilepsy, etc.)
• Serious medical illness or instability for which hospitalization may be likely within the next year.
• Patient does not own a smartphone with a data plan that allows them to receive text messages and access the internet throughout the day.
• Patient is unable to understand study procedures and participate in the informed consent process.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Samsung Electronics: collaborator

Study Sites (1)

Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Mood Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mental Disorders

Study Officials

• Amanda Baker, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Anxiety and Traumatic Stress Disorders

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: April 27, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)