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

Schizophrenia Clinical Trial

— PlaniRev  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04011774
• Other study ID #: D17-P025
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2018
• Est. completion date: August 9, 2024

Study information

• Verified date: July 2022
• Source: Centre Hospitalier St Anne
• Contact: Isabelle AMADO, MD
• Phone: +33 1 45 65 81 80
• Email: i.amado[@]ch-sainte-anne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: August 9, 2024
• Est. primary completion date: August 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• PLANI-REV
Cognitive remediation program.
• RELAXATION
Stimulation with no cognitive remediation.

Locations

Country	Name	City	State
France	Centre Hospitalier DURANT	Etampes
France	Hopital les Murets	La Queue-en-Brie
France	Centre Hospitalier Sainte Anne	Paris
France	Centre Hospitalier Guillaume Régnier	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- 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