Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia: Study Protocol for a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Hospital de la Florida Dra. Eloiza Diaz
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Negative symptoms
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Javiera Libuy Mena
Director
Hospital de la Florida Dra. Eloiza Diaz
Eligibility 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 \>
- •Catatonic symptoms.
- •Previous epilepsy diagnosis.
- •Neurodegenerative disease.
Outcomes
Primary Outcomes
Negative symptoms
Time Frame: 12 weeks
The primary outcome will be the difference in the rate of change in negative symptoms at 3 months of follow-up. Negative symptoms are measured with the Positive and negative syndrome scale (PANSS) negative subscale. Scale's scoring system ranges from 7 to 49 points. A 25% reduction from the baseline score on the PANSS-N will be considered a significant decrease.
Secondary Outcomes
- Positive symptoms(12 weeks)
- Mood symptoms(12 weeks)
- Quality of life: Short Form (36) Health Survey(12 weeks)
- Global functioning(12 weeks)
- Social anxiety(12 weeks)
- Adverse effects(12 weeks)