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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:
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.
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.
Social autonomy, neuropsychological functioning and clinical symptomatology will be measured before, after and at a 6 month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality driving stimulation program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 months |
| World Health Organization Quality of Life Assessment (WHOQLOL-BREF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ROMAIN REY, PH | CH Le Vinatier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital le vinatier | Bron | 69677 | France | |||
| Hopital Vinatier |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| TAU | Behavioral | 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. |
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the quality of life will be evaluated before and after intervention
| 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) | 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 | 7 months |
| Bron |
| 69678 |
| France |