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 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.

Study Overview

• Status: Recruiting
• Conditions: Mood Disorders; Major Depressive Disorder; Mental Health Issue
• Intervention / Treatment: Device: Wearing Samsung smartwatch and filling out daily surveys

• Study Type: Observational
• Enrollment (Anticipated): 215

Contacts and Locations

• Study Contact: Name: Dhea Kothari; Phone Number: 617-726-4299; Email: dkothari2@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital
      • Contact: Dhea Kothari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

U.S. residents recruited through online advertisements.

Description

Inclusion Criteria (Depressed Adults)

1. Age 18-65

2. Meet full DSM-5 diagnostic criteria for a current major depressive episode, as assessed by the MINI for DSM-5 AND exhibit both:

   1. Beck Depression Inventory score of 9 or higher.
   2. Clinical Global Impressions Scale of 3 or higher.
3. If the patient is receiving psychopharmacological or psychosocial treatment, must be stable for 8 weeks prior to enrollment.

Inclusion Criteria (Healthy Controls)

1. Age 18-65

2. Do not meet the criteria for current or past major depressive episodes according to the DSM-5 criteria AND exhibit both:

   1. Beck Depression Inventory score of 8 or lower.
   2. Clinical Global Impressions Scale of 2 or lower.
3. If the patient is receiving psychopharmacological or psychosocial treatment, must be stable for 8 weeks prior to enrollment.

Exclusion Criteria

1. 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.
2. Presence or history of clinically significant neurological disorders and brain injuries (cerebral infarction, cerebral hemorrhage, multiple sclerosis, epilepsy, etc.)
3. Serious medical illness or instability for which hospitalization may be likely within the next year.
4. Patient does not own a smartphone with a data plan that allows them to receive text messages and access the internet throughout the day.
5. Patient is unable to understand study procedures and participate in the informed consent process.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Depressed Adults; Adults with a current diagnosis of Major Depressive Episode	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.
Healthy Controls; Adults without a current or past diagnosis of Major Depressive Episode	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Diagnostic Interview).	Up to 3-months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Samsung Electronics
• Investigators: Principal Investigator: Amanda Baker, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 13, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Smartwatch; Wearable technology
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Depressive Disorder; Disease; Mood Disorders; Depressive Disorder, Major
• Other Study ID Numbers: 2022P002104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No