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

May 5, 2026 updated by: Accexible

Validation of the Accexible Screening and Self-administered Activities for Emotional Well-being in a University Hospitalpopulation (UaDEC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

902

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Coahuila
      • Saltillo, Coahuila, Mexico, 25280
        • Universidad Autónoma de Coahuila (UAdeC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of acceXible for depression and anxiety screening
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Accexible

Collaborators

Universidad Autónoma de Coahuila (UAdeC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2024

Primary Completion (Actual)

April 4, 2025

Study Completion (Actual)

April 4, 2025

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-FCQ-CIGEN-26-11-2024-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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