Planning Your Everyday Life in Virtual Reality : a Study in Schizophrenia;
NCT ID: NCT04011774
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
144 participants
INTERVENTIONAL
2018-10-09
2024-08-09
Brief Summary
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Hypotheses :
* Persons with schizophrenia experience difficulties in daily living and disabilities to plan in everyday life. PLANI-REV program, a serious game with a navigation in a virtual town, in a 15 weekly group sessions could reduce these difficulties compared to the initial assessment. This improvement could be maintained 6 months after the end of the program.
* PLANI-REV could also improve prospective memory, attention, working memory, and visuospatial organization.
* PLANI-REV could induce a clinical improvement, as well as better perception of self-efficiency, self esteem, quality of life, and conversation skills.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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PLANI-REV
Persons with schizophrenia who will benefit from the fifteen weekly sessions of PLANI-REV group program
PLANI-REV
Cognitive remediation program.
RELAXATION
Persons with schizophrenia who will benefit from a non cognitive stimulation, namely RELAXATION, in a day-care clinic or day-care therapeutic activities center during fifteen weekly sessions. This activity will be 15 groups sessions of relaxation.
RELAXATION
Stimulation with no cognitive remediation.
Interventions
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PLANI-REV
Cognitive remediation program.
RELAXATION
Stimulation with no cognitive remediation.
Eligibility Criteria
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Inclusion Criteria
* Diagnostic of schizophrenia or schizoaffective disorder (DSM V), attested by the MINI structured interview (Shehan et al. 1998)
* Who visit for months or year, weekly or several times per week, a day care, or therapeutic activity units outpatients clinics and nursing homes
* French Mother tongue
* Consent of the legal representative caregiver for the patients under representative law (tutelle in French).
* Clinical Stability - Therapeutic stability for at least one month.
* National healthcare assurance
Exclusion Criteria
* Treatments for somatic disease with putative psychotropic effect.
* Electroconvulsive therapy in the last six months
* Illetrism
* IQ\< 70 established with the f-NART.
* Substance misuse or dependence (except Nicotine) or toxic for more than 5 years.
18 Years
50 Years
ALL
No
Sponsors
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Centre Hospitalier St Anne
OTHER
Responsible Party
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Principal Investigators
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Isabelle AMADO, MD
Role: PRINCIPAL_INVESTIGATOR
CHSA
Locations
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Centre Hospitalier DURANT
Étampes, , France
Hopital les Murets
La Queue-en-Brie, , France
Centre Hospitalier Sainte Anne
Paris, , France
Centre Hospitalier Guillaume Régnier
Rennes, , France
Countries
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Central Contacts
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Facility Contacts
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François PETITJEAN, MD
Role: primary
Olivier QUENZER, MD
Role: primary
Isabelle AMADO, MD
Role: primary
Sylvie DOROCANT
Role: backup
David LEVOYER, MD
Role: primary
Other Identifiers
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D17-P025
Identifier Type: -
Identifier Source: org_study_id