Schizophrenia
Conditions
Keywords
Schizophrenia, Virtual reality, Negative symptoms
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.
Interventions
BEHAVIORALVirtual 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.
BEHAVIORALSham- VR
Patients will attend to VR sessions without the software created activities for treatment (sham-VR).
Sponsors
Hospital de la Florida Dra. Eloiza Diaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Chile
Contacts
Primary ContactJaviera Libuy, MD
Backup ContactJonathan Alarcón, MD
Outcome results
None listed