Noninvasive Physiologic Sensors to Assess Depression

Depression Clinical Trial

Official title:

Non-Invasive Physiologic Sensors to Assess Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568865
• Other study ID #: 2015P001913
• Status: Completed
• Start date: January 15, 2016
• Est. completion date: January 3, 2020

Study information

• Verified date: February 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 3, 2020
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• Physiological Sensors
Wearable biosensors can play an important role in depression diagnosis. For this study, we will use a cost-effective, unobtrusive, and non-stigmatizing sensor to monitor physiological signals (including heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), physical activity, and temperature).
• Sleep Monitoring Device
The X4 Device is an internally battery powered FDA-classified Type BF device used for configurable acquisition of physiological signals via EEG.
• Vocal Monitoring
The participants will be provided with a phone app to leave audio diary recordings.
• Mobile Phone
A mobile phone and tablet will be used for various purposes, including, recording of socialization, location, and activity patterns of participants and to collect emotional information based on interactive surveys, as well as for forwarding sleep and physiological sensor measurements to a secure server.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiologic Biorhythms (heart rate)	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.	8 weeks
Primary	Phone Usage	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.	8 weeks
Primary	Voice Characteristics	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.	8 weeks
Primary	Physiologic Biorhythms (Skin conductance)	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.	8 weeks