Clinical trial NCT06588270: Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia
Official title: Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Virtual reality
Negative symptoms
Lead sponsor: Hospital de la Florida Dra. Eloiza Diaz
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Negative symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Positive symptoms
timeFrame: 12 weeks
measure: Mood symptoms
timeFrame: 12 weeks
measure: Quality of life: Short Form (36) Health Survey
timeFrame: 12 weeks
measure: Global functioning
timeFrame: 12 weeks
measure: Social anxiety
timeFrame: 12 weeks
measure: Adverse effects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico La Florida
Study officials:
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