Clinical Validation of Samsung Smartwatch

Major Depressive Disorder Clinical Trial

Official title:

Clinical Validation of Samsung Smartwatch

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767593
• Other study ID #: 2022P002104
• Status: Recruiting
• Start date: March 13, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: Dhea Kothari
• Phone: 617-726-4299
• Email: dkothari2[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mental Health Issue
• Mood Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Samsung Electronics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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