Non-Invasive Physiologic Sensors to Assess Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Physiologic Biorhythms (Skin conductance)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Physiologic Biorhythms (Skin conductance)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
David Mischoulon, MD, PhD
Director, Depression Clinical and Research Program
Massachusetts General Hospital