Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07091344

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

Led by Fundació Sant Joan de Déu · Updated on 2025-08-29

30

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how cognitive, metacognitive, and social cognition factors affect patients with psychosis undergoing VR-based Avatar Therapy for auditory hallucinations. This study aims to understand how these variables and trauma history influence treatment outcomes, with assessments at screening, baseline, during intervention, and post-therapy. The goal is to develop more personalized therapeutic approaches for psychosis. The intervention includes 7 individual VR-based Avatar Therapy sessions over 12 weeks, using virtual reality technology to help patients interact with an avatar representing their main auditory hallucination. Alongside the therapy, participants are evaluated with tools measuring emotion recognition, attributional style, theory of mind, cognitive flexibility, and trauma history to explore their roles in treatment results. Participants will attend assessments at weeks 0, 12, 24, and after therapy completion at week 24. These include cognitive and metacognitive tests, social cognition evaluations, and trauma questionnaires. Researchers will monitor changes in emotion recognition, executive functioning, attributional style, theory of mind, metacognition, cognitive flexibility, global cognitive performance, and working memory throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of schizophrenia spectrum disorder according to DSM-5 criteria
  • Persistent auditory hallucinations for at least 3 months (PANSS hallucination score 2B3)
  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment

Duration - 1 day

Participants undergo baseline assessments of cognition, metacognition, and social cognition to evaluate emotional recognition, attributional style, theory of mind, cognitive flexibility, and trauma history before starting therapy.

1 baseline visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants receive VR-based Avatar Therapy over 12 weeks, consisting of 7 individual sessions using virtual reality technology to help manage distressing auditory hallucinations. Ongoing assessments of cognitive and metacognitive variables occur during this period.

7 therapy sessions over 12 weeks (in-person)

Post-therapy Assessment

Duration - 1 day

Participants complete post-therapy assessments to evaluate changes in cognition, metacognition, and social cognition after completing VR-based Avatar Therapy.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

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

Barcelona, Catalonia, Spain, 08950

Actively Recruiting

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Research Team

S

Susana Ochoa, PhD

L

Luciana Díaz-Cutraro, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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