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

Recruiting · NCT07091344 · Interventional (participants receive a specific treatment) · Lead sponsor: Fundació Sant Joan de Déu

View the official record on ClinicalTrials.gov →

Schizophrenia

Interventions studied

VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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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.
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Exclusion criteria

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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.

Where it is running

1 location listed.

Fundació Sant Joan de Déu - Unitat de Recerca del Parc Sanitari Sant Joan de Déu - Barcelona, Catalonia, Spain

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →