NCT05109845

Virtual Reality and Speech Analysis for the Assessment of Impulsivity and Decision-making

Status unknown Last updated 12 November 2021

What this trial tests

trial testing Spheres & Shield Maze Task in Suicidal Ideation in 300 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
31 July 2023

31 December 2023

Quick facts

Lead sponsor	Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300
Start date	1 January 2022
Primary completion	31 July 2023
Estimated completion	31 December 2023
Sites	1 location across Spain

Drugs / interventions tested

• Spheres & Shield Maze Task

Conditions studied

• Suicidal Ideation — all drugs for Suicidal Ideation →

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz — full company profile →

Who can join

18 and older, any sex, with Suicidal Ideation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Impulsivity is present in a range of mental disorders and has been associated with suicide. Traditional measures of impulsivity have certain limitations, such as the time required for administration or the lack of ecological validity. Virtual Reality (VR) may overcome these issues. This study aims to validate the VR assessment tool "Spheres \& Shield Maze Task" and speech analysis by comparing them with traditional measures. The hypothesis is that these innovative tools will be reliable and acceptable by patients, potentially improving the simultaneous assessment of impulsivity, decision-making, and jumping to conclusions. Methods and analysis: The sample consisted of adults divided into three groups: psychiatric outpatients with a history of suicidal thoughts and/or behaviors, psychiatric outpatients without such a history, and healthy volunteers. The sample size required was estimated at 300 participants (100 per group). Participants will complete the Barratt Impulsiveness Scale 11; the Urgency, Premeditation, Perseverance, Sensation Seeking, Positive Urgency, Impulsive Behavior Scale; Iowa Gambling Task; Continuous Performance Test; Stop signal Task, and Go/no-go task, three questions of emotional affect, the Spheres \& Shield Maze Task and two satisfaction surveys. During these tasks, participant speech will be recorded. External and internal consistency of the VR environment will be calculated. The association between VR-assessed impulsivity and history of suicidal thoughts and/or behavior, and the association between speech and impulsivity and decision-manking will also be explored. Ethics and dissemination: This study will result in a series of manuscripts that will be submitted to peer-reviewed journals for publication. It is hoped that this VR assessment tool combined with speech analysis can be used regularly in research and/or clinical settings in the near future.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Virtual reality and speech analysis for the assessment of impulsivity and decision-making: protocol for a comparison with neuropsychological tasks and self-administered questionnaires.
   de Leon-Martinez S, Ruiz M, Parra-Vargas E, Chicchi-Giglioli I, et al · · 2022 · PMID 35831051 · DOI 10.1136/bmjopen-2021-058486