RecruitingNot ApplicableNCT07091344

Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis

Evaluation of Cognitive, Metacognitive, Social Cognition and Trauma Related-Variables in Patients With Psychosis Receiving VR-Based Avatar Therapy


Sponsor

Fundació Sant Joan de Déu

Enrollment

30 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the relationship between cognitive, metacognitive and social cognition variables in patients with psychosis undergoing VR-based Avatar Therapy for the treatment of auditory hallucinations. In addition to the primary intervention, participants will be assessed using validated tools for emotion recognition, attributional style, theory of mind, neurocognition, and metacognition. The study also explores the potential role of trauma as a predisposing factor. Assessments will be conducted at four time points: screening (week 0), baseline (week 12), intervention period (weeks 12-24), and post-therapy follow-up (week 24). By investigating these variables, this study seeks to better understand their impact on treatment outcomes and contribute to the development of personalized therapeutic approaches.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how cognitive and metacognitive (thinking about one's own thinking) factors are involved in VR-based avatar therapy — a virtual reality treatment where patients face and interact with a digital avatar representing the "voice" they hear — for people with schizophrenia who experience persistent, distressing auditory hallucinations (hearing voices). **You may be eligible if...** - You are 18 or older - You have a diagnosis of schizophrenia spectrum disorder (per DSM-5) - You have experienced persistent auditory hallucinations for at least 3 months - Your medication has been stable for at least 4 weeks - You are fluent in Spanish **You may NOT be eligible if...** - You have no or minimal auditory hallucinations - Your medication has changed recently - You have conditions that prevent you from using VR equipment (e.g., epilepsy triggered by visual stimuli) - You are not Spanish-speaking Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALVR-Based Avatar Therapy with Cognitive and Metacognitive Assessments

VR-Based Avatar Therapy is a 12-week intervention designed to help patients with psychosis manage distressing auditory hallucinations. The therapy consists of 7 individual sessions using virtual reality (VR) technology to externalize the auditory hallucinations, allowing patients to interact with a computer-generated avatar representing their dominant voice. In addition to standard therapy, participants will undergo assessments of cognition, metacognition, and social cognition to explore their impact on treatment outcomes. These assessments include measures of emotion recognition, attributional style, theory of mind, cognitive flexibility, and trauma history. Sessions are conducted using VR headsets and noise-canceling headphones to enhance immersion, and patients receive ongoing therapeutic guidance throughout the process.


Locations(1)

Fundació Sant Joan de Déu - Unitat de Recerca del Parc Sanitari Sant Joan de Déu

Barcelona, Catalonia, Spain

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NCT07091344


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