Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia: Study Protocol for a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Chile
Hospital Clínico La Florida
RECRUITING
Santiago
Contact Information
Primary
Javiera Libuy, MD
jclibuy@uc.cl
+569654112870
Backup
Jonathan Alarcón, MD
jmalarco@uc.cl
+56988139376
Time Frame
Start Date: 2022-05-02
Estimated Completion Date: 2025-09
Participants
Target number of participants: 102
Treatments
Experimental: Virtual reality-based therapy
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.
Sham_comparator: Sham -VR
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.
Related Therapeutic Areas
Sponsors
Leads: Hospital de la Florida Dra. Eloiza Diaz

This content was sourced from clinicaltrials.gov