Planning Your Everyday Life in Virtual Reality : a Study in Schizophrenia;

Study Overview
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Brief Summary
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Patients with schizophrenia , who visit frenquently day-care or day-care activities clinics, often experience difficulties of daily living and cognitive deficits. Living independently is a key for recovery. Cognitive remediation is a therapy which reduces deficit and improves daily living. Nowadays no program exists targeting neurocognitive functions in virtual reality which could mimic everyday life in a virtual town. 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.

Official Title
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PLANning Your Every Day Life I Virtual REality : a Study Schizophrenia. Mathurin Serious Game

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: PLANI-REV
* Other: RELAXATION


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 50 years old. 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: Central Neurological or non stabilized somatic diseases. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLANI-REV<br>Persons with schizophrenia who will benefit from the fifteen weekly sessions of PLANI-REV group program | Other: PLANI-REV<br>* Cognitive remediation program.<br>|
| Active Comparator: RELAXATION<br>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. | Other: RELAXATION<br>* Stimulation with no cognitive remediation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of PLANI-REV : questionnaire scores | the comparison pre/post PLANI-REV of the number of difficulties of daily life using the Profinteg questionnaire | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Profinteg scores 6 months after PLANI-REV. Number of problematic activities; average score for difficulties of problematic activities. | To improve pre/post PLANI-REV and 6 months after, neuropsychological performances in prospective memory, attention, working memory, executive functions, and visual and spatial organization | 16 months |