An interventional study of VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments in Schizophrenia Disorders and Treatment Resistant Hallucinations, sponsored by Fundació Sant Joan de Déu. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Fundació Sant Joan de Déu · Not applicable, Interventional, and Treatment
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.
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 30 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Fundació Sant Joan de Déu is the lead sponsor of 70 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
**Inclusion Criteria:**
**Exclusion Criteria:**
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0, Week 12, Week 24
Childhood Trauma Exposure (Baseline moderator)
Childhood trauma at baseline measured with the CTQ-SF. Total score range: 25-125; higher = greater trauma exposure.
Time frame: 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.
Time frame: Week 0, Week 12, Week 24
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
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.
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.
Started Mar 2024 (actual). Primary completion is estimated for Sep 2026, 30 months after the start.
Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 30 months is close to that.
Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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Fundació Sant Joan de Déu