Non-Invasive Physiologic Sensors to Assess Depression
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Physiologic Biorhythms (Skin conductance)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This project aims to use sensors to monitor physiological signals, sleep patterns, vocal characteristics, activity, location and phone usage in study patients with depression who are receiving standard treatment (compared with healthy controls).
Investigators
David Mischoulon, MD, PhD
Director, Depression Clinical and Research Program
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with Depression (n=40):
- •Adults (ages 18-75),
- •Able to read, understand, and provide written informed consent in English,
- •Meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks, according to the M.I.N.I (Mini International Neuropsychiatric Interview),
- •Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
- •Engaged in or willing to be referred for clinical care for depression treatment as usual (antidepressants and/or psychotherapy),
- •Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
- •Must own a working Android smartphone (Android 2.3+) and use it regularly,
- •Must own a windows PC (or tablet) or a Mac computer (or laptop),
- •Must have access to Internet service every day.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Physiologic Biorhythms (Skin conductance)
Time Frame: 8 weeks
We will measure the skin conductance at baseline and during the treatment period. We will compare the corresponding patterns in patients with depression, as well as in healthy controls.
Phone Usage
Time Frame: 8 weeks
We will measure the cell-phone usage (in the form of texts, web browsing, and phone calls) at the beginning of the study and during the treatment period. We will compare the corresponding phone usage patterns in patients with depression, as well as in healthy controls.
Voice Characteristics
Time Frame: 8 weeks
We will measure the voice characteristics (via reading a 30-second script as part of an audio diary) at the beginning of the study and during the treatment period. We will compare the corresponding voice characteristics in patients with depression, as well as in healthy controls.
Physiologic Biorhythms (heart rate)
Time Frame: 8 weeks
We will measure the heart rate at baseline and during the treatment period. We will compare the corresponding patterns in patients with depression, as well as in healthy controls.