Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT06588270
- Run by
- Hospital de la Florida Dra. Eloiza Diaz
- People needed
- 102
- Starts
- 2022-05-02
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Hospital Clínico La Florida — Santiago, Santiago Metropolitan, Chile (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.