Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis (NCT07091344) | Clinical Trial Compass
RecruitingNot Applicable
Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis
Spain30 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
\*\*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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.