RecruitingNCT05767593

Clinical Validation of Samsung Smartwatch


Sponsor

Massachusetts General Hospital

Enrollment

220 participants

Start Date

Apr 27, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a Samsung smartwatch can accurately detect and track symptoms of depression, by comparing data from the watch with standard clinical assessments in both depressed adults and healthy volunteers. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with a current major depressive episode (with a Beck Depression Inventory score of 9 or higher) — OR — you are healthy (no current depression or psychiatric condition) - If you are currently in psychiatric treatment, your treatment has been stable for at least 8 weeks **You may NOT be eligible if...** - You do not meet the diagnostic criteria for either group (depressed or healthy control) - Your treatment has changed recently (within the last 8 weeks) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWearing 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(1)

Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT05767593


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