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Completed

NCT Number: NCT02568865

Noninvasive Physiologic Sensors to Assess Depression

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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,
  • 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

(for all subjects):

  • 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.

Treatment and study plan

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).

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.

Vocal Monitoring

Other

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Non-Invasive Physiologic Sensors to Assess Depression

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Oct 6, 2015
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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