Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia
Recruiting · NCT06588270 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital de la Florida Dra. Eloiza Diaz
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
A randomised, controlled, double-blind clinical trial will be carried out to evaluate the effectiveness of a VR assisted treatment for negative symptoms in people with schizophrenia. Patients with a standardised diagnosis of schizophrenia meeting the inclusion criteria will receive 12 weekly sessions of VR assisted therapy plus treatment as usual (TAU). A control group will be exposed to a neutral VR environment plus TAU. The hypothesis is that patients who are treated with active VR assisted therapy will have less negative symptoms as rated by the PANSS-N scale, compared to the control group. The protocol was approved by the hospital ethics committee of the Servicio de Salud Metropolitano Suroriente. Patients sign an informed consent form, from which they may withdraw at any point during the intervention.
Who can take part
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 it is running
1 location listed.
- Hospital Clínico La Florida - Santiago, Santiago Metropolitan, Chile