Clinical trial NCT03973853: How Can a Driving Virtual Reality Tool Improve Quality of Life and Social Autonomy in Patients With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Schizophrenia
Keywords: virtual reality
social autonomy
road safety
driving abilities
schizophrenia
cognitive functioning
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Social Autonomy
timeFrame: 7 months
Secondary outcomes:
measure: Rosenberg Self-esteem
timeFrame: 7 months
measure: World Health Organization Quality of Life Assessment (WHOQLOL-BREF)
timeFrame: 7 months
measure: The positive and negative syndrome (PANSS)
timeFrame: 7 months
measure: Car Simulator Evaluation Test
timeFrame: 7 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital le vinatier
city: Bron
country: France
facility: Hopital Vinatier
Study officials:
affiliation: CH Le Vinatier
name: ROMAIN REY, PH
role: PRINCIPAL_INVESTIGATOR
References: