Noninvasive Physiologic Sensors to Assess Depression

NCT02568865 | Completed

• 1 other identifier: 2015P001913
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Major Depressive Disorder

Other: Physiological Sensors; Other: Sleep Monitoring Device; Other: Vocal Monitoring; Other: Mobile Phone

Healthy Volunteers

Other: Physiological Sensors; Other: Sleep Monitoring Device; Other: Vocal Monitoring; Other: Mobile Phone

Interventions

Physiological Sensors OTHER

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).

Healthy Volunteers; Major Depressive Disorder

Sleep Monitoring Device OTHER

The X4 Device is an internally battery powered FDA-classified Type BF device used for configurable acquisition of physiological signals via EEG.

Healthy Volunteers; Major Depressive Disorder

Vocal Monitoring OTHER

The participants will be provided with a phone app to leave audio diary recordings.

Healthy Volunteers; Major Depressive Disorder

Mobile Phone OTHER

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.

Healthy Volunteers; Major Depressive Disorder

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult outpatients with a current major depressive episode (n=40) and healthy adult controls (n=10).

You may qualify if:

• 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.
• Healthy Controls (n=10):
• Adults (ages 18-75),
• Able to read, understand, and provide written informed consent in English,
• Not meet criteria for past or current psychiatric illness, excluding specific phobias, as measured by the M.I.N.I.,
• Not have a first-degree relative with known major psychiatric illness including Major Depressive Disorder, Bipolar Disorder, Psychotic Disorder or Substance Use Disorder,

You may not qualify if:

• Active drug or alcohol use disorder in the past 3 months,
• History of psychosis,
• History of mania or hypomania,
• Epilepsy or history of seizures,
• Untreated hypothyroidism,
• Unstable medical disease,
• Cognitive impairment that would impede adherence to study procedures,
• Acute suicide or homicide risk,
• Current treatment with electroconvulsive therapy, vagal nerve stimulation therapy, deep brain stimulation, transcranial magnetic stimulation therapy, or phototherapy,
• Concurrent participation in other research studies,
• Cannot comprehend or communicate in English,
• Lack of working smartphone or lack of daily access to Internet service,
• Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and
• Inability or unwilling to, at minimum, wear the physiological sensor (E4) bands, fill out the surveys, and record a weekly diary.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Depression Clinical and Research Program

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: October 6, 2015
• Study Start: January 15, 2016
• Primary Completion: July 1, 2018
• Study Completion: January 3, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

US (1)