Noninvasive Physiologic Sensors to Assess Depression

Completed

• Conditions: Depression; Major Depressive Disorder
• Interventions: Other: Physiological Sensors; Other: Sleep Monitoring Device; Other: Vocal Monitoring; Other: Mobile Phone

• Registration Number: NCT02568865
• Lead Sponsor: Massachusetts General Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-06
• Study Start: 2016-01-15
• Primary Completion: 2018-07-01
• Study Completion: 2020-01-03
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with Depression (n=40):

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 major depressive disorder for ≥ 4 weeks, according to the M.I.N.I (Mini International Neuropsychiatric Interview),
4. Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
5. Engaged in or willing to be referred for clinical care for depression treatment as usual (antidepressants and/or psychotherapy),
6. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
7. Must own a working Android smartphone (Android 2.3+) and use it regularly,
8. Must own a windows PC (or tablet) or a Mac computer (or laptop),
9. Must have access to Internet service every day.

Healthy Controls (n=10):

1. Adults (ages 18-75),
2. Able to read, understand, and provide written informed consent in English,
3. Not meet criteria for past or current psychiatric illness, excluding specific phobias, as measured by the M.I.N.I.,
4. Not have a first-degree relative with known major psychiatric illness including Major Depressive Disorder, Bipolar Disorder, Psychotic Disorder or Substance Use Disorder,
5. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
6. Must own a working Android smartphone (Android 2.3+) 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.

Exclusion Criteria (for all subjects):

1. Active drug or alcohol use disorder in the past 3 months,
2. History of psychosis,
3. History of mania or hypomania,
4. Epilepsy or history of seizures,
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. Concurrent participation in other research studies,
11. Cannot comprehend or communicate in English,
12. Lack of working smartphone or lack of daily access to Internet service,
13. Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and
14. Inability or unwilling to, at minimum, wear the physiological sensor (E4) bands, fill out the surveys, and record a weekly diary.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major Depressive Disorder	Physiological Sensors	-
Major Depressive Disorder	Mobile Phone	-
Major Depressive Disorder	Sleep Monitoring Device	-
Healthy Volunteers	Vocal Monitoring	-
Healthy Volunteers	Physiological Sensors	-
Major Depressive Disorder	Vocal Monitoring	-
Healthy Volunteers	Sleep Monitoring Device	-
Healthy Volunteers	Mobile Phone	-

Primary Outcome Measures

Name	Time	Method
Physiologic Biorhythms (Skin conductance)	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	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	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)	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States