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Schizophrenia DisordersMeta-VR-AVATARNCT07091344

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

A study testing VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments in people with Schizophrenia Disorders and Treatment Resistant Hallucinations, run by Fundació Sant Joan de Déu at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSpain
Study dates
1 Mar 2024to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Susana Ochoa, PhD contact

+34936406350 ext. 1253

susana.ochoa@sjd.es

Luciana Díaz-Cutraro, PhD contact

+34936406350

luciana.diaz@sjd.es

Spain1 site, 1 recruiting

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

    Barcelona, Catalonia, 08950

    Susana Ochoa, PhD, +34 93 600 97 51, susana.ochoa@sjd.es

    Luciana Díaz-Cutraro, PhD, +34 93 600 97 51, luciana.diaz@sjd.es

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments
Keywords
VR-based Avatar Therapy, cognition, metacognition, social cognition, psychosis, schizophrenia spectrum disorders, auditory hallucinations, trauma and psychosis, emotion recognition, Personalized therapy
Medical subject headings
Schizophrenia, Psychotic Disorders, Hallucinations, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR-Based Avatar Therapy with Cognitive and Metacognitive AssessmentsBehavioural

    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.

Study groups in NCT07091344
Study groupRoleWhat they receive
VR-Based Avatar Therapy with Cognitive and Metacognitive AssessmentsExperimentalParticipants 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.
Receives: Behavioral: VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 0, Week 12, Week 24

  2. 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.

    Measured: Week 0, Week 12, Week 24.

  3. 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.

    Measured: Week 0, Week 12, Week 24

  4. 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.

    Measured: Week 0, Week 12, Week 24

  5. 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).

    Measured: Week 0, Week 12, Week 24

  6. 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.

    Measured: Week 0, Week 12, Week 24

  7. 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.

    Measured: Week 0, Week 12, Week 24

  8. Change in Working Memory Score

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

    Measured: Week 0, Week 12, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2025
  2. Study start1 Mar 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study employs a single-group pre-post interventional design with a waiting list control phase. All participants will initially undergo a 12-week waiting period (control phase) starting at screening (week 0). Baseline assessments will be conducted at week 12, followed by a 12-week intervention phase where participants receive 7 individual VR-based Avatar Therapy sessions. Post-therapy assessments will be conducted at week 24 to evaluate changes in auditory hallucinations and associated cognitive, metacognitive, and social cognition variables. This design allows for a comprehensive evaluation of both the direct effects of the intervention and the potential moderating or mediating role of the measured variables on therapeutic outcomes.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07091344
Sponsor's protocol ID
PS-01-24
Other IDs
PS-01-24
Acronym
Meta-VR-AVATAR
Status last verified
Jul 2025
First submitted
11 Feb 2025
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 8541250

  • 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.

    PubMed 12615092

  • 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.

    PubMed 34627191

  • 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.

    PubMed 5124116

  • 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.

    PubMed 15099613

  • 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.

    PubMed 17453895

  • 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.

    PubMed 32220501

  • 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.

    PubMed 36513402

  • 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.

    PubMed 37069194

  • 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.

    PubMed 37716848

  • 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.

    PubMed 39468363

Questions about this trial

What is this clinical trial studying?

A study testing VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments in people with Schizophrenia Disorders and Treatment Resistant Hallucinations, run by Fundació Sant Joan de Déu at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Susana Ochoa, PhD (+34936406350 ext. 1253, susana.ochoa@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Emotion Recognition Score (time frame: Week 0, Week 12, Week 24). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07091344, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.

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