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

Not Applicable

Recruiting

• Conditions: Schizophrenia

• Registration Number: NCT06588270
• Lead Sponsor: Hospital de la Florida Dra. Eloiza Diaz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-02
• Study First Submitted: 2022-11-15
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Study First Posted: 2024-09-09
• Last Update Posted: 2024-09-09
• Primary Completion: 2025-05
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Negative symptoms	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 Outcome Measures

Name	Time	Method
Positive symptoms	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.
Quality of life: Short Form (36) Health Survey	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.
Global functioning	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.
Social anxiety	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.
Adverse effects	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.
Mood symptoms	12 weeks	Mood symptoms are assessed with the Calgary depression scale for schizophrenia. Scale's scoring system ranges from 0 to 27 points.

Trial Locations

Locations (1)

Hospital Clínico La Florida; 🇨🇱 Santiago, Chile