Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis (Meta-VR-AVATAR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia Disorders; Treatment Resistant Hallucinations
• Intervention / Treatment: Behavioral: VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susana Ochoa, PhD; Phone Number: 1253 +34936406350; Email: susana.ochoa@sjd.es
• Study Contact Backup: Name: Luciana Díaz-Cutraro, PhD; Phone Number: +34936406350; Email: luciana.diaz@sjd.es

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08950
      • Recruiting
      • Fundació Sant Joan de Déu - Unitat de Recerca del Parc Sanitari Sant Joan de Déu
      • Contact: Susana Ochoa, PhD; Phone Number: +34 93 600 97 51; Email: susana.ochoa@sjd.es
      • Contact: Luciana Díaz-Cutraro, PhD; Phone Number: +34 93 600 97 51; Email: luciana.diaz@sjd.es
      • Principal Investigator: Susana Ochoa, PhD
      • Sub-Investigator: Luciana Diaz-Cutraro, PhD
      • Sub-Investigator: Marina Peniza-Soriano, Master degree

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

**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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments; Participants will receive VR-based Avatar Therapy over a 12-week intervention period, consisting of 7 individual therapy sessions. This intervention is designed to externalize and reframe distressing auditory hallucinations using virtual reality. In addition to the standard therapy, participants will undergo comprehensive assessments of cognition, metacognition, and social cognition at screening (week 0), baseline (week 12), during the intervention (weeks 12-24), and post-therapy (week 24). These measures will evaluate emotional recognition, attributional style, theory of mind, cognitive flexibility, and trauma history, aiming to explore their role in treatment outcomes.

Behavioral: VR-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Emotion Recognition Score	Change in participants' ability to recognize basic emotions using the Faces Test. Score range: 0-20; higher scores = better emotion recognition.	Week 0, Week 12, Week 24
Change in Executive Functioning Score	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.	Week 0, Week 12, Week 24.
Change in Attributional Style Score	Attributional style in ambiguous social situations assessed with the Ambiguous Intentions Hostility Questionnaire (AIHQ). Score range: 0-100; higher scores = greater hostile attribution/conviction.	Week 0, Week 12, Week 24
Change in Theory of Mind Score	Ability to infer others' intentions measured by the Hinting Task. Score range: 0-6; higher scores = better Theory of Mind.	Week 0, Week 12, Week 24
Change in Metacognition Score	Cognitive insight measured by the Beck Cognitive Insight Scale (BCIS): Self-reflectiveness (0-27; higher = better) and Self-certainty (0-21; higher = worse).	Week 0, Week 12, Week 24
Change in Cognitive Flexibility Score	Mental flexibility assessed with the Trail Making Test, Part B. Outcome: time in seconds (maximum 300 seconds); lower times = better performance.	Week 0, Week 12, Week 24
Change in Global Cognitive Performance Score	Global cognition assessed with the Screen for Cognitive Impairment in Psychiatry (SCIP). Total score range: 0-75; higher = better cognitive performance.	Week 0, Week 12, Week 24
Change in Working Memory Score	Working memory assessed by the WAIS-IV Digit Span. Scaled score range: 1-19; higher scores = better performance.	Week 0, Week 12, Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Trauma Exposure (Baseline moderator)	Childhood trauma at baseline measured with the CTQ-SF. Total score range: 25-125; higher = greater trauma exposure.	Week 0 (one-time measure).
Change in Verbal Skills Score	Verbal ability assessed by WAIS-IV Vocabulary. Scaled score range: 1-19; higher scores = better verbal ability.	Week 0, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu

Publications and helpful links

General Publications

• Combs DR, Penn DL, Wicher M, Waldheter E. The Ambiguous Intentions Hostility Questionnaire (AIHQ): a new measure for evaluating hostile social-cognitive biases in paranoia. Cogn Neuropsychiatry. 2007 Mar;12(2):128-43. doi: 10.1080/13546800600787854.
• Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.
• Corcoran R, Mercer G, Frith CD. Schizophrenia, symptomatology and social inference: investigating "theory of mind" in people with schizophrenia. Schizophr Res. 1995 Sep;17(1):5-13. doi: 10.1016/0920-9964(95)00024-g.
• Beck AT, Baruch E, Balter JM, Steer RA, Warman DM. A new instrument for measuring insight: the Beck Cognitive Insight Scale. Schizophr Res. 2004 Jun 1;68(2-3):319-29. doi: 10.1016/S0920-9964(03)00189-0.
• Brebion G, Stephan-Otto C, Cuevas-Esteban J, Usall J, Ochoa S. Impaired memory for temporal context in schizophrenia patients with hallucinations and thought disorganisation. Schizophr Res. 2020 Jun;220:225-231. doi: 10.1016/j.schres.2020.03.014. Epub 2020 Mar 24.
• Lorente-Rovira E, Grasa E, Ochoa S, Corripio I, Pelaez T, Lopez-Carrilero R, Gutierrez-Gea A, Morano-Guillen M, Villagran JM, Bartels-Velthuis AA, Jenner JA, Sanjuan J. Different measures for auditory hallucinations in populations with psychosis. The Validation of the Spanish versions of the Auditory Vocal Hallucination Rating Scale (AVHRS) and the Positive and Useful Voices Inquiry (PUVI). Rev Psiquiatr Salud Ment (Engl Ed). 2022 Oct-Dec;15(4):259-271. doi: 10.1016/j.rpsmen.2020.03.002.
• Stephan-Otto C, Nunez C, Lombardini F, Cambra-Marti MR, Ochoa S, Senior C, Brebion G. Neurocognitive bases of self-monitoring of inner speech in hallucination prone individuals. Sci Rep. 2023 Apr 17;13(1):6251. doi: 10.1038/s41598-023-32042-4.
• Diaz-Cutraro L, Garcia-Mieres H, Dimaggio G, Lysaker P, Moritz S, Ochoa S. Metacognition in psychosis: What and how do we assess it? Span J Psychiatry Ment Health. 2023 Jul-Sep;16(3):206-207. doi: 10.1016/j.rpsm.2022.09.003. Epub 2022 Sep 24. No abstract available.
• Garety PA, Edwards CJ, Jafari H, Emsley R, Huckvale M, Rus-Calafell M, Fornells-Ambrojo M, Gumley A, Haddock G, Bucci S, McLeod HJ, McDonnell J, Clancy M, Fitzsimmons M, Ball H, Montague A, Xanidis N, Hardy A, Craig TKJ, Ward T. Digital AVATAR therapy for distressing voices in psychosis: the phase 2/3 AVATAR2 trial. Nat Med. 2024 Dec;30(12):3658-3668. doi: 10.1038/s41591-024-03252-8. Epub 2024 Oct 28.
• Schmid P, Czekaj A, Frick J, Steinert T, Purdon SE, Uhlmann C. The screen for cognitive impairment in psychiatry (SCIP) as a routinely applied screening tool: pathology of acute psychiatric inpatients and cluster analysis. BMC Psychiatry. 2021 Oct 9;21(1):494. doi: 10.1186/s12888-021-03508-4.
• Reitan RM. Trail making test results for normal and brain-damaged children. Percept Mot Skills. 1971 Oct;33(2):575-81. doi: 10.2466/pms.1971.33.2.575. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: July 21, 2025
• First Posted (Actual): July 29, 2025

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: cognition; social cognition; psychosis; auditory hallucinations; metacognition; Personalized therapy; emotion recognition; schizophrenia spectrum disorders; VR-based Avatar Therapy; trauma and psychosis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Schizophrenia; Psychotic Disorders; Wounds and Injuries; Hallucinations
• Other Study ID Numbers: PS-01-24 (Registry Identifier: ethics comitee Parc Sanitari Sant Joan de Déu)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data (IPD) will be made available upon reasonable request, after publication of primary results, and subject to approval by the research ethics committee and data protection regulations.
• IPD Sharing Time Frame: Anonymized IPD and supporting documents will be made available after publication of the main study results and for a minimum period of 5 years, starting approximately 12 months after study completion.
• IPD Sharing Access Criteria: Qualified researchers affiliated with academic or healthcare institutions may request access to anonymized IPD and supporting documents for independent verification or secondary analysis. Requests will be reviewed by the sponsor and must include a data-sharing agreement and ethics approval. Access will be provided through a secure institutional platform.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No