Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia
NCT ID: NCT06588270
Last Updated: 2024-09-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
102 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-05-02
Study Completion Date
2025-09-30
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Schizophrenia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Caregivers
Investigators
Outcome Assessors
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.
Study Groups
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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.
Group Type
EXPERIMENTAL
Virtual Reality Therapy for the Negative Symptoms of Schizophrenia
Intervention Type
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
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.
Group Type
SHAM_COMPARATOR
Sham- VR
Intervention Type
BEHAVIORAL
Patients will attend to VR sessions without the software created activities for treatment (sham-VR).
Interventions
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Virtual Reality Therapy for the Negative Symptoms of Schizophrenia
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.
Intervention Type
BEHAVIORAL
Sham- VR
Patients will attend to VR sessions without the software created activities for treatment (sham-VR).
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital de la Florida Dra. Eloiza Diaz
OTHER
Sponsor Role
lead
Responsible Party
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Javiera Libuy Mena
Director
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Hospital Clínico La Florida
Santiago, Santiago Metropolitan, Chile
Site Status
RECRUITING
Countries
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Chile
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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SA20I0002
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SA20I0002
Identifier Type: -
Identifier Source: org_study_id
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