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临床试验/NCT07553130
NCT07553130已完成不适用

Validation of the acceXible Screening and Monitoring System for Depression and Anxiety in the Student Population of the Benemérita Universidad Autónoma de Puebla (BUAP)

Accexible1 个研究点 分布在 1 个国家目标入组 785 人开始时间: 2024年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
785
试验地点
1
主要终点
Diagnostic accuracy of acceXible for depression and anxiety screening

研究概览

简要总结

Major depressive disorder (MDD) and anxiety are increasingly prevalent among university student populations, yet early detection remains reliant on psychometric instruments tied to diagnostic criteria (e.g., PHQ-9, GAD). Emerging evidence suggests that depression affects both the acoustic properties and content of speech, making speech analysis a promising candidate as a digital biomarker for early screening.

This study evaluates the validity of acceXible, a speech-based machine learning platform, for the detection and monitoring of depression and anxiety in the student population of the Benemérita Universidad Autónoma de Puebla (BUAP), Mexico. AcceXible captures spontaneous speech through open-ended interview tasks and applies automated acoustic and linguistic analysis.

The primary objective is to evaluate the validity of the acceXible spontaneous speech analysis system for depression and anxiety screening, assessed against the PHQ and GAD scales as reference standards. Secondary objectives include examining associations between speech-derived variables and other study measures, evaluating participant engagement with digital mental health resources, assessing user satisfaction with the platform, and analyzing longitudinal changes in scores across follow-up assessments.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of voluntary written informed consent
  • Age 16-25 years
  • Current enrollment at BUAP
  • Spanish language proficiency
  • Access to a mobile device with internet connectivity
  • Ability to understand and follow basic acceXible usage instructions

排除标准

  • Refusal to participate
  • Psychomotor agitation
  • Sensory impairment (visual or auditory)
  • Cognitive impairment

结局指标

主要结局

Diagnostic accuracy of acceXible for depression and anxiety screening

时间窗: Baseline

Sensitivity, specificity, and positive predictive value of the acceXible speech analysis system relative to validated Spanish-language versions of the PHQ-9 and GAD-7 as reference standards. Sensitivity is defined as the probability of correctly classifying a participant with abnormal scores; specificity as the probability of correctly classifying a non-affected participant; and positive predictive value as the probability that a participant flagged by acceXible truly meets criteria for depression or anxiety.

次要结局

未报告次要终点

研究者

发起方
Accexible
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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