NCT07091344Recruiting
Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis
Evaluation of Cognitive, Metacognitive, Social Cognition and Trauma Related-Variables in Patients With Psychosis Receiving VR-Based Avatar Therapy
Source: ClinicalTrials.gov · Last updated 29 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 11 Feb 2025
- Start date
- 1 Mar 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Fundació Sant Joan de Déu
- Diseases
- Schizophrenia
- NCT number
- NCT07091344
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Mar 2024 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- \*\*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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundació Sant Joan de Déu - Unitat de Recerca del Parc Sanitari Sant Joan de Déu Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.