NCT07553130

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
785

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

machine learningdepressionanxietyAccexiblescreening

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of acceXible for depression and anxiety screening

    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.

    Baseline

Interventions

AcceXibleDEVICE

Speech analysis

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

University students enrolled at the Benemérita Universidad Autónoma de Puebla (BUAP), Puebla, Mexico.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benemérita Universidad Autónoma de Puebla

Puebla City, 72570, Mexico

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 27, 2026

Study Start

November 20, 2024

Primary Completion

June 6, 2025

Study Completion

June 6, 2025

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations