Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder: A Multi-Site Fully Remote E-Clinical Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of the Kintsugi's technology's prediction
研究概览
简要总结
Major Depressive Disorder (MDD) is the leading cause of disability worldwide. Depression and anxiety disorders are among the most prevalent of all mental disorders, with an estimated annual prevalence of 9.7% and 18.1% respectively.
It has been known for the last 100 years that depression and anxiety both likely affect vocal acoustic properties. In 1921, Emil Kraepelin, characterized depressed patient's voices as having a lower pitch, lower volume, lower rate of speech, more monotony of prosody as well as more hesitations, stuttering, and whispering.
Mechanistically, it is possible that the neural circuitry involved in the pathophysiology of mood and anxiety disorders impinge upon the neural circuit involved in speech production, affecting qualities that include rate, prosody, speech latency and other paralinguistic features. Thus, acoustic features of speech may be one of the more readily accessible biomarkers for these conditions.
Given this understanding, the investigators sought to develop a passive vocal biomarker instrument for depression and anxiety screening that could markedly expand access as well as standardize the quality of screening in primary care settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult males and or females over the age of 18 at the time of informed consent
- •Access to a laptop, smartphone or tablet with a functioning microphone
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Fluency in English
- •For depressed participant group: Current diagnosis of depression
- •For non-depressed participant group: No current or prior diagnosis of depression
排除标准
- •Visual impairment that would make it difficult for the participant to follow the instructions
- •Motor impairment that would make it difficult for the participant to follow the instructions
- •Any known history of neurodegenerative or Central Nervous System disorders (e.g. MS, Dementia, TBI, Stroke, etc.)
- •Any known history of major psychiatric disorder other than depression (e.g. Bipolar Disorder, Schizophrenia, etc.)
- •Any known history of substance abuse
结局指标
主要结局
Sensitivity and specificity of the Kintsugi's technology's prediction
时间窗: July 30, 2021
Sensitivity and specificity of the Kintsugi's technology's prediction compared to HAM-D and HAM-A scores.
次要结局
- Sensitivity and specificity to depression at the GAD-7 score of 10(July 30, 2021)
- Sensitivity and specificity to depression at the PHQ-9 score of 10(July 30, 2021)