Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Behavioral: Virtual Reality Therapy for the Negative Symptoms of SchizophreniaBehavioral: Sham- VR
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 102
- 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.
- 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
- Arm && Interventions
Group Intervention Description Virtual reality-based therapy Virtual Reality Therapy for the Negative Symptoms of Schizophrenia 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. Sham -VR 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.
- 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.
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.
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.
Trial Locations
- Locations (1)
Hospital Clínico La Florida
🇨🇱Santiago, Chile