Clinical Validation of Samsung Smartwatch

Launched by MASSACHUSETTS GENERAL HOSPITAL · Mar 2, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new feature developed by Samsung that aims to help monitor mental health, specifically focusing on detecting signs of depression and anxiety using a smartwatch. The study will look at how well the "Mindfulness Index," created by Samsung, can identify individuals diagnosed with Major Depressive Disorder (MDD). The researchers want to see if the data collected through the smartwatch—like heart rate, sleep patterns, and daily activities—can reliably indicate someone's mental health status.

To participate in the trial, you would need to be between 18 and 65 years old. If you're currently experiencing major depression, you would need a diagnosis confirming this from a qualified professional. Healthy individuals without any history of depression can also take part as a comparison group. Participants will wear the smartwatch daily for three months, answer daily surveys about their mood, and have virtual check-ins with a clinician at specific points. This study offers a chance to explore how technology could play a role in understanding and improving mental health.

Gender

ALL

Eligibility criteria

• • 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 or Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) 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.