Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03973853

How Can a Driving Virtual Reality Tool Improve Quality of Life and Social Autonomy in Patients With Schizophrenia

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Hôpital le Vinatier · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALVirtual 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.
BEHAVIORALTAUThis 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.

Timeline

Start date
2019-06-25
Primary completion
2019-12-30
Completion
2019-12-30
First posted
2019-06-04
Last updated
2025-03-07

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03973853. Inclusion in this directory is not an endorsement.