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Evaluation of Cognitive, Metacognitive, Social Cognition and Trauma Related-Variables in Patients With Psychosis Receiving VR-Based Avatar Therapy
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.
This interventional study investigates the impact of cognitive, metacognitive, and social cognition variables on the outcomes of VR-based Avatar Therapy for auditory hallucinations in patients with psychosis. Participants will be assessed at four key time points: screening (week 0), baseline (week 12), during the intervention (weeks 12-24), and post-therapy (week 24). The intervention consists of 7 individual VR-based Avatar Therapy sessions delivered over 12 weeks. The therapy uses virtual reality to externalize and reframe distressing auditory hallucinations, helping participants develop more adaptive responses. In addition to evaluating the therapy's effectiveness, the study incorporates validated tools to measure: Social Cognition: Emotional recognition (Test de Reconocimiento Emocional), attributional style (AIHQ), theory of mind (Hinting Task), and social perception (SFRT-2). Metacognition: Insight and cognitive monitoring using the BCIS and CBQ. Cognition: Neuropsychological functions, including attention, flexibility, and memory (SCIP, Stroop, TMT, and Vocabulary WAIS). Trauma as a predisposing factor: Using the Childhood Trauma Questionnaire (CTQ). By examining these variables, the study aims to deepen the understanding of their influence on treatment outcomes and inform the development of personalized therapeutic approaches for psychosis.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fundació Sant Joan de Déu - Unitat de Recerca del Parc Sanitari Sant Joan de Déu
Barcelona, Catalonia, Spain
Start Date
March 1, 2024
Primary Completion Date
September 30, 2026
Completion Date
December 30, 2026
Last Updated
August 29, 2025
30
ESTIMATED participants
VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments
BEHAVIORAL
Lead Sponsor
Fundació Sant Joan de Déu
NCT07010614
NCT06641297
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06939088