Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06588270

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico La Florida

Santiago, Santiago Metropolitan, Chile

Location status: Recruiting

Location contact

Ximena Fuentes, MD

CONTACT

[email protected]

+56992241711

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Sham- VR

Behavioral

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

Primary outcomes

  1. 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

  1. Positive symptoms

    Time frame: 12 weeks

    Positive symptoms are measured with the Positive and negative syndrome scale (PANSS) positive subscale. It consists of seven items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution and hostility. Scale's scoring system ranges from 7 to 49 points. No changes from the baseline PANSS-P score are expected.

  2. Mood symptoms

    Time frame: 12 weeks

    Mood symptoms are assessed with the Calgary depression scale for schizophrenia. Scale's scoring system ranges from 0 to 27 points.

  3. Quality of life: Short Form (36) Health Survey

    Time frame: 12 weeks

    The Short Form (36) Health Survey is a self-applied questionnaire that addresses eight life dimensions: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. It will be used to assess quality of life. As it is a dimensional scale, it does not have a cutoff score.

  4. Global functioning

    Time frame: 12 weeks

    Global assessment of functioning (GAF) is a numeric scale of social, occupational and psychological functioning. Scale's scoring system ranges from 10 to 100 points.

  5. Social anxiety

    Time frame: 12 weeks

    Social anxiety symptoms are measured with Social Interaction Anxiety Scale (SIAS). This is a self applied, twenty items instrument. Scale's scoring system ranges from 0 to 80 points.

  6. Adverse effects

    Time frame: 12 weeks

    Adverse effects are measured with the Simulator Sickness Questionnaire (SSQ). This instrument assesses 16 subjective items and was developed to accommodate symptoms specific to simulator technology. It can be self applied or clinician rated. Participants are asked to assign a score from 0-3 for each of the sixteen items on the SSQ. Total scores can be associated with negligible (< 5), minimal (5 - 10), significant (10 - 15), concerning (15 - 20) and bad (>20) symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Javiera Libuy, MD

CONTACT

[email protected]

+569654112870

Jonathan Alarcón, MD

CONTACT

[email protected]

+56988139376

Sponsors and collaborators

Lead sponsor

Hospital de la Florida Dra. Eloiza Diaz

Other

Registry information

Official study title

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

Acronym: VR-SCHIZO

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.