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NCT Number: NCT07091344

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

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.

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Key information

Conditions

Schizophrenia Disorders Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Treatment Resistant Hallucinations Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Barcelona, Catalonia, 08950, Spain

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

**Inclusion Criteria:**

  • 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.

Treatment and study plan

VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments

Behavioral

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.

Primary outcomes

  1. Change in Emotion Recognition Score

    Time frame: Week 0, Week 12, Week 24

    Change in participants' ability to recognize basic emotions using the Faces Test. Score range: 0-20; higher scores = better emotion recognition.

  2. Change in Executive Functioning Score

    Time frame: Week 0, Week 12, Week 24.

    Change in Executive Functioning Score Executive functioning assessed with the Wisconsin Card Sorting Test (WCST). Outcomes include number of categories completed (0-6; higher = better) and number of perseverative errors (no fixed maximum; lower = better). The task ends when the participant completes 6 categories or after all 128 cards are placed.

  3. Change in Attributional Style Score

    Time frame: Week 0, Week 12, Week 24

    Attributional style in ambiguous social situations assessed with the Ambiguous Intentions Hostility Questionnaire (AIHQ). Score range: 0-100; higher scores = greater hostile attribution/conviction.

  4. Change in Theory of Mind Score

    Time frame: Week 0, Week 12, Week 24

    Ability to infer others' intentions measured by the Hinting Task. Score range: 0-6; higher scores = better Theory of Mind.

  5. Change in Metacognition Score

    Time frame: Week 0, Week 12, Week 24

    Cognitive insight measured by the Beck Cognitive Insight Scale (BCIS): Self-reflectiveness (0-27; higher = better) and Self-certainty (0-21; higher = worse).

  6. Change in Cognitive Flexibility Score

    Time frame: Week 0, Week 12, Week 24

    Mental flexibility assessed with the Trail Making Test, Part B. Outcome: time in seconds (maximum 300 seconds); lower times = better performance.

  7. Change in Global Cognitive Performance Score

    Time frame: Week 0, Week 12, Week 24

    Global cognition assessed with the Screen for Cognitive Impairment in Psychiatry (SCIP). Total score range: 0-75; higher = better cognitive performance.

  8. Change in Working Memory Score

    Time frame: Week 0, Week 12, Week 24

    Working memory assessed by the WAIS-IV Digit Span. Scaled score range: 1-19; higher scores = better performance.

Other outcomes

  1. Childhood Trauma Exposure (Baseline moderator)

    Time frame: Week 0 (one-time measure).

    Childhood trauma at baseline measured with the CTQ-SF. Total score range: 25-125; higher = greater trauma exposure.

  2. Change in Verbal Skills Score

    Time frame: Week 0, Week 12, Week 24

    Verbal ability assessed by WAIS-IV Vocabulary. Scaled score range: 1-19; higher scores = better verbal ability.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Registry information

Official study title

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

Acronym: Meta-VR-AVATAR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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