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| Name | Class |
|---|---|
| Samsung Electronics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depressed Adults | Adults with a current diagnosis of Major Depressive Episode |
| |
| Healthy Controls | Adults without a current or past diagnosis of Major Depressive Episode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearing Samsung smartwatch and filling out daily surveys | Device | Participants will wear a Samsung smartwatch and fill out daily surveys about their mood and depressive symptoms. |
| 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 or DIAMOND Diagnostic Interview). | Up to 3-months |
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Inclusion Criteria (Depressed Adults)
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:
If the patient is receiving psychopharmacological or psychosocial treatment, must be stable for 8 weeks prior to enrollment.
Inclusion Criteria (Healthy Controls)
Age 18-65
Do not meet the criteria for current or past major depressive episodes according to the DSM-5 criteria AND exhibit both:
If the patient is receiving psychopharmacological or psychosocial treatment, must be stable for 8 weeks prior to enrollment.
Exclusion Criteria
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U.S. residents recruited through online advertisements.
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Baker, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001523 | Mental Disorders |
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