Voice Biomarkers Predictive of Depression and Anxiety: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19,533
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
The objective of this study is to collect data to improve the sensitivity and specificity of Kintsugi Voice's (formerly KiVATM) predictions on audio files. A web-based audio recording tool will be used to record voice sample and ask participants the PHQ-9 and GAD-7 questions. A voluntary subset of participants will then be assessed by mental health professionals with the Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) scores.
详细描述
Participants will be recruited via various online mediums to participate in a voluntary observational study. Completing the consent and survey on their smart-phone, tablet, or computer, the participant will be asked to provide a 1-minute response to an audio prompt "How was your day?" After recording their response, the participant will be asked to complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 measures independently.
In a second voluntary phase of the study, participants who indicated a score higher than 20, will be contacted by the research team via email to determine if they are interested in a voluntary follow-up to their initial study participation. Participants who would like to take part in the additional survey will complete additional voice recording responses to prompts and complete the Patient History Questionnaire and Generalized Anxiety Disorder-7. These participants will be contacted by a Mental Health Professional to discuss seeking mental health resources and clinicians, as well as, complete the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale via the telephone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and or females over the age of 18 at the time of informed consent. Adults with a known history of depression and/or anxiety and adults without a known history of depression and/or anxiety will be included in this study.
- •Access to a laptop, smart-phone 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
排除标准
- •Visual impairment that would make it difficult for the participant to see the web-based survey
- •Motor impairment that would make it difficult for the participant to use the web-based survey
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: Through study completion, on average 12months
Participants will be interviewed by mental health professionals using the clinically validated Hamilton Depression Rating Scale, which has a score range of 0 to 54, where higher scores are associated with higher severity of depression.
Hamilton Anxiety Rating Scale
时间窗: Through study completion, on average 12 months
Participants will be interviewed by mental health professionals using the clinically validated Hamilton Anxiety Rating Scale, which has a score range of 0 to 56, where higher scores are associated with higher severity anxiety.
次要结局
未报告次要终点