Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia

Last updated: September 5, 2024
Sponsor: Hospital de la Florida Dra. Eloiza Diaz
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tourette's Syndrome

Psychosis

Mood Disorders

Treatment

Sham- VR

Virtual Reality Therapy for the Negative Symptoms of Schizophrenia

Clinical Study ID

NCT06588270
SA20I0002
SA20I0002
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of schizophrenia made by the treating psychiatrist and corroborated by ateam'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 monthsand not currently on queue for psychiatric hospitalization.

  • No concomitant active substance abuse disorder, excluding nicotine.

  • Subjects are capable of providing informed consent.

Exclusion

Exclusion Criteria:

  • Previous diagnosis of learning disability according either to ICD- 10 or clinicalhistory

  • 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.

Study Design

Total Participants: 102
Treatment Group(s): 2
Primary Treatment: Sham- VR
Phase:
Study Start date:
May 02, 2022
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Hospital Clínico La Florida

    Santiago,
    Chile

    Active - Recruiting

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