How Can a Driving Virtual Reality Tool Improve Quality of Life and Social Autonomy in Patients With Schizophrenia
NCT ID: NCT03973853
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-06-25
2019-12-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active group with virtual reality stimulation
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
Virtual reality driving stimulation program
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.
Treatment as Usual group (TAU)
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.
TAU
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.
Interventions
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Virtual reality driving stimulation program
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.
TAU
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.
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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)
18 Years
50 Years
ALL
No
Sponsors
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Hôpital le Vinatier
OTHER
Responsible Party
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Principal Investigators
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ROMAIN REY, PH
Role: PRINCIPAL_INVESTIGATOR
CH Le Vinatier
Locations
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Hôpital le vinatier
Bron, , France
Hopital Vinatier
Bron, , France
Countries
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Other Identifiers
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2018-A02799-46
Identifier Type: -
Identifier Source: org_study_id
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