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

Centre Hospitalier St Anne

Status: Enrolling

Conditions: Schizophrenia

Treatments: Other: PLANI-REV; Other: RELAXATION

Study type: Interventional

Funder types: Other

Identifiers

NCT04011774

D17-P025

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

PLANI-REV

Experimental group

Description:

Persons with schizophrenia who will benefit from the fifteen weekly sessions of PLANI-REV group program

Treatment:

Other: PLANI-REV

RELAXATION

Active Comparator group

Description:

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.

Treatment:

Other: RELAXATION