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

Inclusion Criteria7

  • Adults aged 18 years or older.
  • Diagnosis of schizophrenia spectrum disorder according to DSM-5 criteria.
  • Experience of persistent auditory hallucinations for at least 3 months (PANSS hallucination score ≥ 3).
  • Stable medication dosage for at least 4 weeks prior to recruitment.
  • Fluent in the spoken language of the study site (Spanish).
  • Able to provide informed consent.
  • Regular psychiatric follow-up care.

Exclusion Criteria8

  • Inability to identify a dominant voice for Avatar Therapy intervention.
  • Intellectual disability based on medical history.
  • Active substance abuse.
  • Central nervous system injury or neurological disorders affecting cognitive performance.
  • Severe visual impairment that precludes the use of VR technology.
  • Aversion to virtual reality or prior experience of simulator sickness.
  • Current suicidal ideation or risk.
  • Lack of cooperation or inability to comply with study procedures.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07091344


Related Trials