Clinical trial NCT04011774: Planning Your Everyday Life in Virtual Reality : a Study in Schizophrenia;
Official title: PLANning Your Every Day Life I Virtual REality : a Study Schizophrenia. Mathurin Serious Game
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of PLANI-REV : questionnaire scores
timeFrame: 10 months
Secondary outcomes:
measure: - Profinteg scores 6 months after PLANI-REV. Number of problematic activities; average score for difficulties of problematic activities.
timeFrame: 16 months
Other outcomes:
Locations:
city: Etampes
country: France
facility: Centre Hospitalier DURANT
city: La Queue-en-Brie
country: France
facility: Hopital les Murets
city: Paris
country: France
facility: Centre Hospitalier Sainte Anne
city: Rennes
country: France
facility: Centre Hospitalier Guillaume Régnier
Study officials:
affiliation: CHSA
name: Isabelle AMADO, MD
role: PRINCIPAL_INVESTIGATOR
References: