SchizophreniaNCT03146364
Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia
A study testing Virtual Reality - Virtual Interactive Supermarket in people with Schizophrenia, run by HaEmek Medical Center, Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Virtual Reality - Virtual Interactive Supermarket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Schizophrenia or Scizoeffective diagnosis, Hebrew language proficiency, three weeks of anti-psychotic drug treatment
Who cannot join
- score of under 70 in the 3MS (screen test), physical disability, neurological diagnosis (ex. dementia)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Virtual Reality - Virtual Interactive Supermarket
- Keywords
- Virtual Reality
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality - Virtual Interactive SupermarketDevice
Also called SeeMe
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
| Study group | Role | What they receive |
|---|---|---|
| Hospitalization patients | Experimental | patients in psychiatric hospitalization will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis) Receives: Device: Virtual Reality - Virtual Interactive Supermarket |
| Ambulatory patients | Experimental | patients being treated in a clinic will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis) Receives: Device: Virtual Reality - Virtual Interactive Supermarket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified 4 item test
"buy" 4 items with budget constraints, using the VIS
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Revised Observed Tasks of Daily Living (OTDL-R)
evaluation of IADL using various tasks include problem solving
Measured: through study completion, an average of 1 year
Executive Function Performance Test (EFPT)
executive function assessment using 5 different tasks
Measured: 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.
Measured: 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
Measured: through study completion, an average of 1 year
Adults Subjective Assessment of Participation
participation questionnaire that examine the level of engagement in different occupations
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alon Reshef, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146364
- Sponsor's protocol ID
- HaEmekAlon
- Status last verified
- May 2017
- First submitted
- 1 Apr 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Executive Function With Static and Dynamic Shopping Assignment in Virtual Reality Among People With Schizophrenia
- ClinicalTrials.gov ID
- NCT03146364
- Acronym / sponsor ID
- HaEmekAlon
- Conditions
- Schizophrenia
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalization patients | Experimental | Device: Virtual Reality - Virtual Interactive Supermarketpatients in psychiatric hospitalization will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis) |
| Ambulatory patients | Experimental | Device: Virtual Reality - Virtual Interactive Supermarketpatients being treated in a clinic will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Schizophrenia or Scizoeffective diagnosis, Hebrew language proficiency, three weeks of anti-psychotic drug treatment
Key exclusion criteria (1 listed)
- score of under 70 in the 3MS (screen test), physical disability, neurological diagnosis (ex. dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality - Virtual Interactive SupermarketAlso: SeeMeSeeMe 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 | Device | Ambulatory patients, Hospitalization patients |
Primary outcome
Modified 4 item test
Time frame: through study completion, an average of 1 year
"buy" 4 items with budget constraints, using the VIS
5 secondary outcomes
Revised Observed Tasks of Daily Living (OTDL-R)
Time frame: through study completion, an average of 1 year
Executive Function Performance Test (EFPT)
Time frame: through study completion, an average of 1 year
Trail Making Test A & B (TMT)
Time frame: through study completion, an average of 1 year
The positive and negative syndrome scale (PANSS)
Time frame: through study completion, an average of 1 year
Adults Subjective Assessment of Participation
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality - Virtual Interactive Supermarket in people with Schizophrenia, run by HaEmek Medical Center, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alon Reshef, Dr (04-6494351, AlonReshef1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified 4 item test (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.