Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia (VR-SCHIZO)

Hospital de la Florida Dra. Eloiza Diaz

Status: Enrolling

Conditions: Schizophrenia

Treatments: Behavioral: Sham- VR; Behavioral: Virtual Reality Therapy for the Negative Symptoms of Schizophrenia

Study type: Interventional

Funder types: Other

Identifiers

NCT06588270

SA20I0002 (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups

Virtual reality-based therapy

Experimental group

Description:

The intervention group will receive a VR experience with a treatment software. The aim is to immerse the patient in an interactive environment that invites him/her to explore and complete goal-directed activities with sensory, visual and/or auditory rewards. The therapy will be delivered with the support of a therapist once per week for 12 consecutive weeks. Each therapy session will last approximately 20 minutes.

Treatment:

Behavioral: Virtual Reality Therapy for the Negative Symptoms of Schizophrenia

Sham -VR

Sham Comparator group

Description:

Control group's patients will continue pharmacological and non pharmacological usual treatment. Additionally, these patients will attend to VR sessions without the software created activities for treatment (sham-VR). Sessions will be the same length and quantity as the intervention group's sessions.

Treatment:

Behavioral: Sham- VR