Active — Not RecruitingNot Applicable

Clinical Validation of Samsung Smartwatch

United States220 participantsStarted 2023-04-27

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: Up to 3-months

Trial details

NCT IDNCT05767593

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-01

View on ClinicalTrials.gov More Major Depressive Disorder trials