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

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality driving stimulation program
TAU
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring virtual reality, social autonomy, road safety, driving abilities, schizophrenia, cognitive functioning

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital le vinatierRecruiting
  • Hopital Vinatier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active group with virtual reality stimulation

Treatment as Usual group (TAU)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
World Health Organization Quality of Life Assessment (WHOQLOL-BREF)
the quality of life will be evaluated before and after intervention
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)
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

Full Information

First Posted
April 25, 2019
Last Updated
January 26, 2022
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT03973853
Brief Title
How Can a Driving Virtual Reality Tool Improve Quality of Life and Social Autonomy in Patients With Schizophrenia
Acronym
Schizovirt
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
virtual reality, social autonomy, road safety, driving abilities, schizophrenia, cognitive functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active group with virtual reality stimulation
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment as Usual group (TAU)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality driving stimulation program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Autonomy
Description
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).
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Rosenberg Self-esteem
Description
the outcome measure of self esteem will be the modification before and after the score of scale. It is a brief auto-questionnaire.
Time Frame
7 months
Title
World Health Organization Quality of Life Assessment (WHOQLOL-BREF)
Description
the quality of life will be evaluated before and after intervention
Time Frame
7 months
Title
The positive and negative syndrome (PANSS)
Description
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)
Time Frame
7 months
Title
Car Simulator Evaluation Test
Description
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
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ROMAIN REY, PH
Phone
+33(0)437915280
Email
Romain.Rey@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
VERONIQUE VIAL
Phone
+33(0)437915531
Email
Veronique.Vial@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROMAIN REY, PH
Organizational Affiliation
CH Le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital le vinatier
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
thierry d'Amato, MD, PhD
Phone
+33437915565
Facility Name
Hopital Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROMAIN REY, PH
Phone
+33(0)437915280
Email
Romain.Rey@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
VERONIQUE VIAL
Phone
+33(0)437915531
Email
Veronique.Vial@ch-le-vinatier.fr

12. IPD Sharing Statement

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

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