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

Not Applicable

Recruiting

• Conditions: Schizophrenia Disorders; Treatment Resistant Hallucinations

• Registration Number: NCT07091344
• Lead Sponsor: Fundació Sant Joan de Déu

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2025-02-11
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

**

Exclusion Criteria

**

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Emotion Recognition Score	Week 0, Week 12, Week 24	Change in participants' ability to recognize facial emotions using the Faces Test (Baron-Cohen et al., 2001). This computerized task includes 20 facial stimuli representing basic emotions. Score (0-20); Higher scores = better emotion recognition.
Change in Executive Functioning Score	Week 0, Week 12, Week 24.	Change in executive functioning assessed by the Wisconsin Card Sorting Test (WCST), including number of perseverative errors and categories completed. Number of errors or categories; Lower errors = better performance
Change in Attributional Style Score	Week 0, Week 12, Week 24	Change in participants' attributional style in ambiguous social situations, as measured by the Ambiguous Intentions Hostility Questionnaire (AIHQ). Total and subscale scores; Higher scores = greater attributional bias (worse outcome)
Change in Cognitive Flexibility Score	Week 0, Week 12, Week 24	Change in mental flexibility as assessed by the Trail Making Test (TMT) Part B. Time in seconds; Lower times = better performance
Change in Theory of Mind Score	Week 0, Week 12, Week 24	Change in ability to infer the thoughts and intentions of others, as measured by The Hinting Task. Score by subtests to avoid learning effect (0-6); Higher scores = better Theory of Mind
Change in Metacognition Score	Week 0, Week 12, Week 24	Change in cognitive insight, including self-reflectiveness and self-certainty, as measured by the Beck Cognitive Insight Scale (BCIS). Self-reflectiveness (0-27), Self-certainty (0-21); Higher self-reflectiveness = better insight / Higher self-certainty = worse insight
Change in Global Cognitive Performance Score	Week 0, Week 12, Week 24	Change in global cognitive functioning assessed with the Screen for Cognitive Impairment in Psychiatry (SCIP). This brief battery evaluates immediate and delayed verbal learning, working memory, verbal fluency, and processing speed. Total score (0-75); Higher scores = better cognitive performance
Change in Working Memory Score	Week 0, Week 12, Week 24	Change in working memory as assessed by the Digit Span subtest of the WAIS-IV. Scaled score (1-19); Higher scores = better performance.

Trial Locations

Locations (1)

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