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

NCT06588270 | Recruiting

• 1 other identifier: SA20I0002
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Virtual reality; Negative symptoms

Outcome Measures

Primary Outcomes (1)

• Negative symptoms

  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.

  12 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

Virtual reality-based therapy

EXPERIMENTAL

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.

Behavioral: Virtual Reality Therapy for the Negative Symptoms of Schizophrenia

Sham -VR

SHAM COMPARATOR

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.

Behavioral: Sham- VR

Interventions

Virtual Reality Therapy for the Negative Symptoms of Schizophrenia BEHAVIORAL

VRTNSS is a 12-session therapy using psychological intervention principles. Each therapy session will involve engaging with different VR based tasks where participants can experience different activities.

Virtual reality-based therapy

Sham- VR BEHAVIORAL

Patients will attend to VR sessions without the software created activities for treatment (sham-VR).

Sham -VR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Hospital de la Florida Dra. Eloiza Diaz: lead

Study Sites (1)

Hospital Clínico La Florida

Santiago, Santiago Metropolitan, Chile

RECRUITING

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MeSH Terms

Conditions

Schizophrenia

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Javiera Libuy, MD

CONTACT

+569654112870; jclibuy@uc.cl

Jonathan Alarcón, MD

CONTACT

+56988139376; jmalarco@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of allocation will be maintained for the research workers until all outcome measures for all participants have been collected. Blindness will be maintained using a range of measures (e.g. separate offices for therapist and researchers, protocols for answering phones and emails and security for electronic randomization information). The trial statistician will be also blind to the randomization outcome.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: The study will be a double-blind, randomized controlled trial (RCT). Patients will be divided into two groups. The intervention group will receive a VR experience with a treatment software, while the control group will receive a VR experience without the software. All patients will continue on their current medications

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: September 19, 2024
• Study Start: May 2, 2022
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CL (1)