SchizophreniaSchizovirtNCT03973853
How Can a Driving Virtual Reality Tool Improve Quality of Life and Social Autonomy in Patients With Schizophrenia
A study testing Virtual reality driving stimulation program and TAU in people with Schizophrenia, run by Hôpital le Vinatier at 2 sites in France.
Trial summary
Schizophrenia is a mental health issue that affects mostly young adults. The main symptoms are hallucinations, delirium, and agitation, poor social relations, lack of motivation, thought disorganization. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Virtual reality driving stimulation program and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Jun 2019to 30 Dec 2019
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnostic of Schizophrenia according to a DSM-5 criteria
- Aged between 18-50 years
- Enrolled in an empowerment project
- Stable clinical status, without treatment modification for 3 months
- Capacity to consent
- Affiliated to a social security scheme
Who cannot join
- Opposition of patient or legal guardian
- Background of head trauma, neurological pathology with cerebral repercussions or severe somatic or ocular disease not stabilized or resulting in pain> 3 months
- Visual disorders related to surgery or known ocular pathology leading to visual loss or visual field restriction
- Mental retardation < 80
- Simultaneous participation in another cognitive remediation program (6-month exclusion period)
- Simultaneous participation in another study involving cognitive processes (6-month exclusion period)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Importance of the Nurse's Role in Treatment Observance and Social Autonomy in Schizophrenia Using an Innovating Tool for Daily Transports: a Pilot Study
Schizophrenia is a mental health issue that affects mostly young adults. The main symptoms are hallucinations, delirium, and agitation, poor social relations, lack of motivation, thought disorganization. Also, patients suffering from schizophrenia encounter important cognitive disorders affecting memory, executive functioning and attention. These cognitive alterations are often linked to social exclusion and stigmatisation.
Antipsychotic treatments are effective mainly on the positive dimension of symptoms (hallucinations etc…); however their action is very limited on the cognitive difficulties encountered. Psychosocial techniques can be used to treat the cognitive symptoms, such as cognitive remediation or psychosocial rehabilitation .
Read more
These cognitive difficulties mainly have an impact on patients' daily life, affecting their abilities to drive, for example. Schizophrenic patients suffer more road accidents than healthy subjects .
Thus, considering this information, it appears important to us to address this driving problem for various reasons:
- Firstly, knowing how to drive is often linked to daily autonomy,
- Secondly, driving is also linked to keeping an active social network and to work.
Patients suffering from schizophrenia often encounter difficulties in learning how to drive which reinforces the stigmatisation and fear of failure.
Thus, a specific driving and theory training prior to driving lessons could be a way of helping patients in their cognitive difficulties and pass their driving test. Daily transports mobilize a number of cognitive functions (attentional vigilance, working memory, psychomotor coordination, divided attention, visuo-spatial abilities .
Using a driving virtual reality tool could constitute an ecological cognitive remediation tool, by simulating daily driving situations. This "serious game" approach enables us to involve virtual reality in training but also in assessments. The driving simulator allows standardized evaluations and could also become a therapeutic tool of ecological cognitive remediation.
This study thus appears interesting in order to develop road safety and daily autonomy.
Read the detailed description
In order to study the impact of a driving virtual reality tool on daily autonomy and cognitive functioning, patients will undertake a number of training sessions using the tool.
This study will be composed of 2 groups of schizophrenic patients.
- the active group will benefit from 14 one hour sessions on the driving simulator. The training will be progressive and organized enabling the remediation of the different cognitive functions necessary to driving.
- the TAU (treatment as usual) group will carry on their usual care during the length of the study. This group will help confirm the pertinence of using such a tool on a daily basis. After the end of the study, the 14 session training will be suggested to the patients who are willing.
Social autonomy, neuropsychological functioning and clinical symptomatology will be measured before, after and at a 6 month follow-up.
- Conditions
- Schizophrenia
- Being tested
- Virtual reality driving stimulation program, TAU
- Keywords
- virtual reality, social autonomy, road safety, driving abilities, schizophrenia, cognitive functioning
- 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 driving stimulation programBehavioural
This group will benefit of 14 one hour sessions, using the driving simulator. The program is based on a progressive training, focused on the remediation of the cognitive functions specific to driving. The tool and the type of training aim to help transfer the abilities to daily life.
TAUBehavioural
This group will carry on their usual treatment during the whole length of the study. Patients will be randomized into the 2 groups. This TAU group will be the control group and will help assess the effectiveness of the stimulation program. The stimulation sessions will be proposed to the TAU group at the end of study.
| Study group | Role | What they receive |
|---|---|---|
| Active group with virtual reality stimulation | Experimental | The subjects in this arm will undertake 14 sessions of virtual reality stimulation. The program will be delivered by a nurse, trained to the use of such a tool, and familiar with cognitive remediation techniques. Before and after these 14 sessions, social autonomy, daily life skills, cognitive domains and self-esteem will be measured Receives: Behavioral: Virtual reality driving stimulation program |
| Treatment as Usual group (TAU) | Placebo comparator | Patients in this group will carry on benefiting from their usual care with no additional program. They will be assessed before and after a 3 month period for social autonomy, daily life skills, cognitive domains and self-esteem. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Autonomy
the primary outcome will be the modification before and after intervention of the total score on the Social Autonomy scale. It is obtained by 5 domains (personal health, everyday life, money, social relationships, and affective life).
Measured: 7 months
Secondary outcomes (4)
Rosenberg Self-esteem
the outcome measure of self esteem will be the modification before and after the score of scale. It is a brief auto-questionnaire.
Measured: 7 months
World Health Organization Quality of Life Assessment (WHOQLOL-BREF)
the quality of life will be evaluated before and after intervention
Measured: 7 months
The positive and negative syndrome (PANSS)
the measure of cognitive functioning specific to the driving situation will be the modification before and after intervention of the score obtained at the proposed neuropsychological evaluation (executive, attentional and social)
Measured: 7 months
Car Simulator Evaluation Test
Change in score "Car Simulator Evaluation Test" . This measure is repeated at the beginning and at the end of the intervention to highlight the impact of the " Car Simulator " program, and 6 months later to investigate the benefits.
the impact of the program on road safety knowledge outcome will be assessed by the modification before and after of scores using the assessments available with the driving tool
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start25 Jun 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Why it stopped: Decision to stop the study
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROMAIN REY, PH, Principal investigator, CH Le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973853
- Sponsor's protocol ID
- 2018-A02799-46
- Acronym
- Schizovirt
- Status last verified
- Mar 2025
- First submitted
- 25 Apr 2019
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of the Nurse's Role in Treatment Observance and Social Autonomy in Schizophrenia Using an Innovating Tool for Daily Transports: a Pilot Study
- ClinicalTrials.gov ID
- NCT03973853
- Acronym / sponsor ID
- Schizovirt / 2018-A02799-46
- Conditions
- Schizophrenia
- Keywords
- virtual reality, social autonomy, road safety, driving abilities, schizophrenia, cognitive functioning
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision to stop the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 4 Jun 2019 (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.
Schizophrenia is a mental health issue that affects mostly young adults. The main symptoms are hallucinations, delirium, and agitation, poor social relations, lack of motivation, thought disorganization. Also, patients suffering from schizophrenia encounter important cognitive disorders affecting memory, executive functioning and attention. These cognitive alterations are often linked to social exclusion and stigmatisation.
Antipsychotic treatments are effective mainly on the positive dimension of symptoms (hallucinations etc…); however their action is very limited on the cognitive difficulties encountered. Psychosocial techniques can be used to treat the cognitive symptoms, such as cognitive remediation or psychosocial rehabilitation .
These cognitive difficulties mainly have an impact on patients' daily life, affecting their abilities to drive, for example. Schizophrenic patients suffer more road accidents than healthy subjects .
Thus, considering this information, it appears important to us to address this driving problem for various reasons:
- Firstly, knowing how to drive is often linked to daily autonomy,
- Secondly, driving is also linked to keeping an active social network and to work.
Patients suffering from schizophrenia often encounter difficulties in learning how to drive which reinforces the stigmatisation and fear of failure.
Thus, a specific driving and theory training prior to driving lessons could be a way of helping patients in their cognitive difficulties and pass their driving test. Daily transports mobilize a number of cognitive functions (attentional vigilance, working memory, psychomotor coordination, divided attention, visuo-spatial abilities .
Using a driving virtual reality tool could constitute an ecological cognitive remediation tool, by simulating daily driving situations. This "serious game" approach enables us to involve virtual reality in training but also in assessments. The driving simulator allows standardized evaluations and could also become a therapeutic tool of ecological cognitive remediation.
This study thus appears interesting in order to develop road safety and daily autonomy.
Detailed description
In order to study the impact of a driving virtual reality tool on daily autonomy and cognitive functioning, patients will undertake a number of training sessions using the tool.
This study will be composed of 2 groups of schizophrenic patients.
- the active group will benefit from 14 one hour sessions on the driving simulator. The training will be progressive and organized enabling the remediation of the different cognitive functions necessary to driving.
- the TAU (treatment as usual) group will carry on their usual care during the length of the study. This group will help confirm the pertinence of using such a tool on a daily basis. After the end of the study, the 14 session training will be suggested to the patients who are willing.
Social autonomy, neuropsychological functioning and clinical symptomatology will be measured before, after and at a 6 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group with virtual reality stimulation | Experimental | Behavioral: Virtual reality driving stimulation programThe subjects in this arm will undertake 14 sessions of virtual reality stimulation. The program will be delivered by a nurse, trained to the use of such a tool, and familiar with cognitive remediation techniques. Before and after these 14 sessions, social autonomy, daily life skills, cognitive domains and self-esteem will be measured |
| Treatment as Usual group (TAU) | Placebo comparator | Behavioral: TAUPatients in this group will carry on benefiting from their usual care with no additional program. They will be assessed before and after a 3 month period for social autonomy, daily life skills, cognitive domains and self-esteem. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnostic of Schizophrenia according to a DSM-5 criteria
- Aged between 18-50 years
- Enrolled in an empowerment project
- Stable clinical status, without treatment modification for 3 months
- Capacity to consent
Key exclusion criteria (6 listed)
- Opposition of patient or legal guardian
- Background of head trauma, neurological pathology with cerebral repercussions or severe somatic or ocular disease not stabilized or resulting in pain> 3 months
- Visual disorders related to surgery or known ocular pathology leading to visual loss or visual field restriction
- Mental retardation < 80
- Simultaneous participation in another cognitive remediation program (6-month exclusion period)
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 driving stimulation programThis group will benefit of 14 one hour sessions, using the driving simulator. The program is based on a progressive training, focused on the remediation of the cognitive functions specific to driving. The tool and the type of training aim to help transfer the abilities to daily life. | Behavioural | Active group with virtual reality stimulation |
| TAUThis group will carry on their usual treatment during the whole length of the study. Patients will be randomized into the 2 groups. This TAU group will be the control group and will help assess the effectiveness of the stimulation program. The stimulation sessions will be proposed to the TAU group at the end of study. | Behavioural | Treatment as Usual group (TAU) |
Primary outcome
Social Autonomy
Time frame: 7 months
the primary outcome will be the modification before and after intervention of the total score on the Social Autonomy scale. It is obtained by 5 domains (personal health, everyday life, money, social relationships, and affective life).
4 secondary outcomes
Rosenberg Self-esteem
Time frame: 7 months
World Health Organization Quality of Life Assessment (WHOQLOL-BREF)
Time frame: 7 months
The positive and negative syndrome (PANSS)
Time frame: 7 months
Car Simulator Evaluation Test
Time frame: 7 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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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.
ROMAIN REY, PH principal investigator
CH Le Vinatier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality driving stimulation program and TAU in people with Schizophrenia, run by Hôpital le Vinatier at 2 sites in France.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Autonomy (time frame: 7 months). 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 7 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.