NCT07091344 Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis
| NCT ID | NCT07091344 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundació Sant Joan de Déu |
| Condition | Schizophrenia Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-03-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
\*\*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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07091344 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Schizophrenia Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07091344 currently recruiting?
Yes, NCT07091344 is actively recruiting participants. Contact the research team at susana.ochoa@sjd.es for enrollment information.
Where is the NCT07091344 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT07091344 clinical trial?
NCT07091344 is sponsored by Fundació Sant Joan de Déu. The trial plans to enroll 30 participants.
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