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

Not Applicable

• Conditions: Schizophrenia

• Registration Number: NCT04011774
• Lead Sponsor: Centre Hospitalier St Anne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-09
• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-07-05
• Study First Posted: 2019-07-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-13
• Primary Completion: 2024-08-09
• Study Completion: 2024-08-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of PLANI-REV : questionnaire scores	10 months	the comparison pre/post PLANI-REV of the number of difficulties of daily life using the Profinteg questionnaire

Secondary Outcome Measures

Name	Time	Method
- Profinteg scores 6 months after PLANI-REV. Number of problematic activities; average score for difficulties of problematic activities.	16 months	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

Trial Locations

Locations (4)

Centre Hospitalier DURANT; 🇫🇷 Etampes, France

Hopital les Murets; 🇫🇷 La Queue-en-Brie, France

Centre Hospitalier Sainte Anne; 🇫🇷 Paris, France

Centre Hospitalier Guillaume Régnier; 🇫🇷 Rennes, France