Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia

Evaluation of Executive Function With Static and Dynamic Shopping Assignment in Virtual Reality Among People With Schizophrenia

This Cross-sectional Study Included Patients that diagnosed with schizophrenia, aged 18-55, 20 of which hospitalized in mental health department and 20 in medical follow-up.

Different test will be administered, in two or three sessions, to evaluate cognitive ability, function ability and participation.

The results of the VIS shopping task performance (statically & dynamically) and its correlation with the cognitive and function tests as well as the participation questionnaire will be examined. These findings will indicate whether the shopping task is valid to assess executive functions for people with schizophrenia and whether it is ecologically valid.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Device: Virtual Reality - Virtual Interactive Supermarket

Detailed Description

Background:

Schizophrenia often reflect by decrease in executive functions that may cause difficulty in Instrumental Activities of Daily Living (IADL). We've found it very difficult to simulate these functions with the existing tools in the clinic and to assess IADL accordingly.

The use of Virtual Reality (VR) became popular in the last decade to overcome these limitations in clinical practice and assessment of functioning in IADL. VR is a computer program that simulates a functional environment in which the subject impacts on events through various actions. Recent studies indicated that VR can be used to assess cognitive abilities and functioning of population with schizophrenia. As far as we know, no researches were performed using Virtual Interactive Shopping (VIS) in this population, nor did dynamic evaluation was used to identify potential learning abilities. The aim of this study is to examine the validity of the shopping task in the VIS, performed statically and dynamically, in order to assess executive function, and the ability to reflect cognitive, functional and participation ability among people that diagnosed with schizophrenia.

Method:

This Cross-sectional Study Included Patients that diagnosed with schizophrenia, aged 18-55, 20 of which hospitalized in mental health department and 20 in medical follow-up.

Different test will be administered, in two or three sessions, to evaluate cognitive ability, function ability and participation.

The results of the VIS shopping task performance (statically & dynamically) and its correlation with the cognitive and function tests as well as the participation questionnaire will be examined. These findings will indicate whether the shopping task is valid to assess executive functions for people with schizophrenia and whether it is ecologically valid.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Schizophrenia or Scizoeffective diagnosis, Hebrew language proficiency, three weeks of anti-psychotic drug treatment

Exclusion Criteria:

• score of under 70 in the 3MS (screen test), physical disability, neurological diagnosis (ex. dementia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hospitalization patients; patients in psychiatric hospitalization will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)	Device: Virtual Reality - Virtual Interactive Supermarket; SeeMe is a PC based, innovative, comprehensive, clinician-controlled exercise and diagnostic system. SeeMe is designed to aid the rehabilitation process, and track patients' progress. Virtual Interactive Supermarket- one of the SeeMe Tasks, the user need to buy products by according to specific instruction; Other Names: SeeMe
Experimental: Ambulatory patients; patients being treated in a clinic will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)	Device: Virtual Reality - Virtual Interactive Supermarket; SeeMe is a PC based, innovative, comprehensive, clinician-controlled exercise and diagnostic system. SeeMe is designed to aid the rehabilitation process, and track patients' progress. Virtual Interactive Supermarket- one of the SeeMe Tasks, the user need to buy products by according to specific instruction; Other Names: SeeMe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified 4 item test	"buy" 4 items with budget constraints, using the VIS	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Observed Tasks of Daily Living (OTDL-R)	evaluation of IADL using various tasks include problem solving	through study completion, an average of 1 year
Executive Function Performance Test (EFPT)	executive function assessment using 5 different tasks	through study completion, an average of 1 year
Trail Making Test A & B (TMT)	The Trail Making Test is an accessible neuropsychological instrument that provides the examiner with information on a wide range of cognitive skills and can be completed in 5-10 min.	through study completion, an average of 1 year
The positive and negative syndrome scale (PANSS)	The Positive and Negative Syndrome Scale (PANSS) was developed out of the need for a well-operationalized method of assessing these syndromes in schizophrenia, including their relationship to one another and to global psychopathology	through study completion, an average of 1 year
Adults Subjective Assessment of Participation	participation questionnaire that examine the level of engagement in different occupations	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: April 1, 2017
• First Submitted That Met QC Criteria: May 6, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 6, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Virtual Reality
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: HaEmekAlon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No