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

NCT03973853 | Withdrawn

• 1 other identifier: 2018-A02799-46
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia

Keywords

virtual reality; social autonomy; road safety; driving abilities; schizophrenia; cognitive functioning

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Rosenberg Self-esteem

  7 months

• World Health Organization Quality of Life Assessment (WHOQLOL-BREF)

  7 months

• The positive and negative syndrome (PANSS)

  7 months

• Car Simulator Evaluation Test

  7 months

Study Arms (2)

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

Behavioral: Virtual reality driving stimulation program

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.

Behavioral: TAU

Interventions

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.

Active group with virtual reality stimulation

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.

Treatment as Usual group (TAU)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (2)

Hôpital le vinatier

Bron, 69677, France

Location

Hopital Vinatier

Bron, 69678, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• ROMAIN REY, PH

  CH Le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: June 4, 2019
• Study Start: June 25, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

FR (2)