Virtual reality therapy for negative symptoms in schizophrenia
Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia: Study Protocol for a Randomized Controlled Trial
This study is testing if virtual reality therapy can help reduce negative symptoms in people with schizophrenia compared to a neutral VR experience.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hospital de la Florida Dra. Eloiza Diaz Academic / other |
| Locations | 1 site (Santiago, Santiago Metropolitan) |
| Trial ID | NCT06588270 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of virtual reality (VR) therapy in reducing negative symptoms in individuals diagnosed with schizophrenia. Participants will be randomly assigned to receive either 12 weekly sessions of active VR therapy combined with standard treatment or a control group that experiences a neutral VR environment alongside standard treatment. The study aims to measure changes in negative symptoms using the PANSS-N scale, comparing outcomes between the two groups. The trial has received ethical approval and requires informed consent from participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a stable diagnosis of schizophrenia and no recent psychiatric hospitalizations.
Not a fit: Patients with predominant positive symptoms, severe verbal expression difficulties, or other significant physical disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life for patients with schizophrenia by alleviating negative symptoms.
How similar studies have performed: While the use of VR in mental health is an emerging field, similar studies have shown promising results in addressing various psychological conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of schizophrenia made by the treating psychiatrist and corroborated by a team's psychiatrist under CIE-10 criteria. * Age between 18 to 65 years-old. * Outpatient setting, * Clinical stability defined as no psychiatric hospitalizations in the last 6 months and not currently on queue for psychiatric hospitalization. * No concomitant active substance abuse disorder, excluding nicotine. * Subjects are capable of providing informed consent. Exclusion Criteria: * Previous diagnosis of learning disability according either to ICD- 10 or clinical history * Verbal expression difficulties, determined by language or medical causes. * Deafness and/or blindness. * Other physical handicaps to use VR devices. * Predominant positive symptoms, defined as PANNS-C \> 0. * Catatonic symptoms. * Previous epilepsy diagnosis. * Neurodegenerative disease.
Where this trial is running
Santiago, Santiago Metropolitan
- Hospital Clínico La Florida — Santiago, Santiago Metropolitan, Chile (Recruiting)
Study contacts
- Study coordinator: Javiera Libuy, MD
- Email: jclibuy@uc.cl
- Phone: +569654112870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.