Monitoring depression using sensors

Leveraging Artificial Intelligence for the Assessment of Severity of Depressive Symptoms

This study is testing whether wearable sensors and mobile apps can help track depression in people with Major Depressive Disorder to see how well they respond to treatment.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT04370002 on ClinicalTrials.gov

What this trial studies

This longitudinal study will monitor 100 individuals with Major Depressive Disorder (MDD) over 12 weeks to develop an objective, sensor-based algorithm for detecting depression and predicting treatment response. Participants will provide self-reports, undergo in-person assessments, and wear devices that capture physiological data, alongside mobile app data on socialization and activity. The study aims to integrate these diverse data sources using advanced statistical methods to create a valid assessment of depressive symptoms that does not rely on clinician interviews.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a current diagnosis of Major Depressive Disorder and a Hamilton Depression Rating Scale score of 18 or higher.

Not a fit: Patients with active substance use disorders, psychotic disorders, or certain neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and treatment of depression through objective assessments.

How similar studies have performed: Other studies utilizing sensor-based approaches for mental health monitoring have shown promise, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Adults (ages 18-75),
2. Able to read, understand, and provide written informed consent in English,
3. Meet criteria for a primary psychiatric diagnosis of current major depressive disorder
4. Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
5. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
6. Must own a working smartphone and use it regularly,
7. Must own a windows PC (or tablet) or a Mac computer (or laptop),
8. Must have access to Internet service every day.
9. Must have started antidepressant medications, changed medication dosage, or started therapy within 3 weeks

Exclusion Criteria:

1. Active drug or alcohol use disorder in the past 3 months,
2. History of psychotic disorder,
3. History of mania or hypomania,
4. Epilepsy or history of Seizure Disorder (including PNES), narcolepsy, Alzheimer Disease, Parkinson's Disease, ALS, Severe TBI, Dementia, MS, Cerebral Palsy, and Neuralgia.
5. Untreated hypothyroidism,
6. Unstable medical disease,
7. Cognitive impairment that would impede adherence to study procedures,
8. Acute suicide or homicide risk,
9. Current treatment with electroconvulsive therapy, vagal nerve stimulation therapy, deep brain stimulation, transcranial magnetic stimulation therapy, or phototherapy,
10. Cannot comprehend or communicate in English,
11. Lack of working smartphone or lack of daily access to Internet service,
12. Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and
13. Inability or unwilling to, at minimum, wear the physiological sensor (E4) wristbands, download monitoring apps, and fill out the surveys.
14. Participants with more than two treatment failures (more than two adequate trials of meds on the basis of ATRQ) in the current mood episode.

Where this trial is running

Boston, Massachusetts and 1 other locations

• Depression Clinical Research Program — Boston, Massachusetts, United States (RECRUITING)
• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)

Conditions: Unipolar Depression, Depression, Sensors