Validation of Accexible Screening and Self-Administered Activities for Emotional Well-Being in a University Hospital (UaDEC)

NCT07578155 | Completed

• 1 other identifier: P-FCQ-CIGEN-26-11-2024-1
• Study Type: observational
• Target: 902
• Locations: 1 country
• Sites: 1

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 Universidad Autónoma de Coahuila (UAdeC), 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.

Conditions

Depression - Major Depressive Disorder; Anxiety

Keywords

machine learning; speech analysis; depression; anxiety; well-being

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

AcceXible DEVICE

Speech analysis

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

University students enrolled at the Universidad Autónoma de Coahuila (UAdeC)

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)

Sponsors & Collaborators

• Accexible: lead
• Universidad Autónoma de Coahuila (UAdeC): collaborator

Study Sites (1)

Universidad Autónoma de Coahuila (UAdeC)

Saltillo, Coahuila, 25280, Mexico

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

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

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: March 19, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)