Validation of Accexible as a Tool for Screening and Monitoring Depression.

Sponsor

Accexible (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06044818

Collaborator

(none)

178

Enrollment

Location

15.3

Anticipated Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Major depressive disorder (MDD) is a chronic disease with a prevalence around 8-12% and is considered one of the most debilitating disease worldwide.

A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.

The present study has the objective of validating Accexible as a tool for Screening and Monitoring Depression.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder (MDD)	Device: Accexible

Study Design

Study Type:

Observational

Anticipated Enrollment :

178 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Validación Del Sistema de Cribaje y Seguimiento de acceXible Para depresión.

Anticipated Study Start Date :

Sep 24, 2023

Anticipated Primary Completion Date :

Oct 3, 2024

Anticipated Study Completion Date :

Jan 3, 2025

Arms and Interventions

Arm	Intervention/Treatment
Healthy	Device: Accexible Speech Analysis
Depression	Device: Accexible Speech Analysis

Arm

Intervention/Treatment

Healthy

Device: Accexible

Speech Analysis

Depression

Device: Accexible

Speech Analysis

Outcome Measures

Primary Outcome Measures

Prevalence of Depression [An average of 1 year]
questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adult 18-65 years of age.
Participants must have Spanish as their first language (able to speak and understand verbal messages).
Participants must have mobile phone with internet.
Participants must have the ability to understand AcceXible's basic instructions.
Participants must agree to participate in the study and have voluntarily signed the informed consent.

Exclusion Criteria for patients:

To have received a diagnosis of neurodegeneration.
To have significant vision problems that would affect the ability to perceive visual stimuli.
To have significant hearing problems that would affect the ability to understand verbal cues.
To be unable to give informed consent to participate in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vall d'Hebron Institut de Investigación (VHIR)	Barcelona		Spain	08035

Sponsors and Collaborators

Accexible

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Accexible

ClinicalTrials.gov Identifier:

NCT06044818

Other Study ID Numbers:

PR(AG)86/2023

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depressive Disorder

Depressive Disorder, Major

Study Results

No Results Posted as of Sep 21, 2023