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Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03973853
Study type Interventional
Source Hôpital le Vinatier
Contact ROMAIN REY, PH
Phone +33(0)437915280
Email Romain.Rey@ch-le-vinatier.fr
Status Recruiting
Phase N/A
Start date June 25, 2019
Completion date June 2023

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