Validation of a smartwatch for detecting depression

Clinical Validation of Samsung Smartwatch

This study is testing a Samsung smartwatch that aims to help spot signs of depression and anxiety in people, including those diagnosed with Major Depressive Disorder and healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 220 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05767593 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a Samsung smartwatch algorithm designed to identify signs of depression and anxiety in users. Participants, including individuals diagnosed with Major Depressive Disorder and healthy controls, will wear the smartwatch and complete daily surveys over a three-month period. The study aims to validate the 'Mindfulness Index,' a visual representation of mental health, by comparing smartwatch data with clinical assessments. A total of 215 participants will be recruited to achieve the target sample size of 150 individuals.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-65 diagnosed with Major Depressive Disorder or healthy individuals without a history of mood disorders.

Not a fit: Patients with a lifetime history of bipolar disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive tool for early detection and monitoring of mental health conditions.

How similar studies have performed: Other studies have shown promise in using wearable technology for mental health monitoring, making this approach both innovative and relevant.

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.

Where this trial is running

Boston, Massachusetts

• Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Amanda Baker, PhD — Massachusetts General Hospital
• Study coordinator: Dhea Kothari

Conditions: Major Depressive Disorder, Mood Disorders, Mental Health Issue, Wearable technology, Smartwatch