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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Device: Accexible

• Study Type: Observational
• Enrollment (Estimated): 178

Contacts and Locations

• Study Contact: Name: Carla Zaldua; Phone Number: +34 649 33 22 95; Email: carla@accexible.com

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Vall d'Hebron Institut de Investigación (VHIR)
    • Contact: Amanda Rodríguez Urrutia, MD, PhD; Phone Number: 4295 +34 93 489 40 00; Email: amanda.rodriguez@vallhebron.cat
    • Principal Investigator: Amanda Rodríguez Urrutia, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Cases: adults with suspected depression.

Controls: healthy controls without depression criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Depression	Device: Accexible; Speech Analysis
Healthy	Device: Accexible; Speech Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Depression	questionnaire	An average of 1 year

Collaborators and Investigators

• Sponsor: Accexible

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): October 3, 2024
• Study Completion (Estimated): January 3, 2025

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: PR(AG)86/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No