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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Other: PLANI-REV; Other: RELAXATION

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle AMADO, MD; Phone Number: +33 1 45 65 81 80; Email: i.amado@ch-sainte-anne.fr
• Study Contact Backup: Name: Sylvie DOROCANT; Phone Number: +33 1 45 65 77 28; Email: s.dorocant@ch-sainte-anne.fr

Study Locations

• France
  • Etampes, France
    • Recruiting
    • Centre Hospitalier DURANT
    • Contact: François PETITJEAN, MD
  • La Queue-en-Brie, France, 94510
    • Recruiting
    • Hopital les Murets
    • Contact: Olivier QUENZER, MD
  • Paris, France, 75674
    • Recruiting
    • Centre hospitalier Sainte Anne
    • Contact: Isabelle AMADO, MD; Email: i.amado@ch-sainte-anne.fr
    • Contact: Sylvie DOROCANT; Email: s.dorocant@ch-sainte-anne.fr
  • Rennes, France, 35703
    • Recruiting
    • Centre Hospitalier Guillaume Regnier
    • Contact: David LEVOYER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Investigators: Principal Investigator: Isabelle AMADO, MD, CHSA

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Anticipated): August 9, 2024
• Study Completion (Anticipated): August 9, 2024

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: D17-P025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No