跳至主要内容
临床试验/NCT06464575
NCT06464575Enrolling By Invitation不适用

Prediction of a Structured Clinical Assessment by Patient Reported Outcomes and Machine Learning Algorithms: A Comparative Study

Ellipsis Health1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2024年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
540
试验地点
1
主要终点
Primary Outcome B

研究概览

简要总结

Participants will be recruited to complete self reported surveys normally used as standards of care for screening and monitoring depression and anxiety symptom severity, provide a voice sample composed of an answer to open ended questions and then be assessed by a mental health professional using structured and clinically validated assessment tools for depression and anxiety. Their voice will be analyzed by machine learning models that predict the severity of depression and anxiety symptoms. The models' performance will be compared to the clinician assessments and how that correlation compares to a similar comparison between the clinician assessments with the self reported surveys. It is hypothesized that the performance of the machine learning models in assessing the severity of depression and anxiety symptoms is no worse than the self reported surveys when both are compared to clinician assessments. It is also hypothesized that presence or absence of the diagnoses of Major Depressive Disorder and Generalized Anxiety Disorder can be predicted better than chance by the analysis of the participant's voice sample using machine learning models.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
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

入选标准

  • Native speaker or conversant in English
  • Access to smartphone or computer with microphone
  • Provision of esigned and dated informed consent form
  • Willingness to adhere to the study protocol
  • To participate in the subsequent clinical interview portion of this study in addition to the above inclusion criteria, a participant must provide an evaluable and qualified voice sample.

排除标准

  • Speech impairments or other conditions that impact their ability to speak clearly
  • Under the influence of recreational drugs or alcohol
  • Ill or experiencing heavy allergies or temporary conditions affecting respiration, voice, or speaking.

结局指标

主要结局

Primary Outcome B

时间窗: 4 days

Extent of categorical agreement, measured in weighted kappa, between Ellipsis Health Software as a Medical Device severity of anxiety and clinician's rating of severity of anxiety.

Primary Outcome A

时间窗: 4 days

Extent of categorical agreement, measured in weighted kappa, between Ellipsis Health Software as a Medical Device severity of depression and clinician's rating of severity of depression.

次要结局

  • Secondary Outcome A(4 days)
  • Secondary Outcome B(4 days)

研究者

发起方
Ellipsis Health
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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