Planning Your Everyday Life in Virtual Reality : a Study in Schizophrenia; (PlaniRev)
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PLANI-REV
RELAXATION
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
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.
Sites / Locations
- Centre Hospitalier DURANTRecruiting
- Hopital les MuretsRecruiting
- Centre Hospitalier Sainte AnneRecruiting
- Centre Hospitalier Guillaume RégnierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PLANI-REV
RELAXATION
Arm Description
Persons with schizophrenia who will benefit from the fifteen weekly sessions of PLANI-REV group program
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.
Outcomes
Primary Outcome Measures
Efficacy of PLANI-REV : questionnaire scores
the comparison pre/post PLANI-REV of the number of difficulties of daily life using the Profinteg questionnaire
Secondary Outcome Measures
- 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
Full Information
NCT ID
NCT04011774
First Posted
April 29, 2019
Last Updated
December 12, 2022
Sponsor
Centre Hospitalier St Anne
1. Study Identification
Unique Protocol Identification Number
NCT04011774
Brief Title
Planning Your Everyday Life in Virtual Reality : a Study in Schizophrenia;
Acronym
PlaniRev
Official Title
PLANning Your Every Day Life I Virtual REality : a Study Schizophrenia. Mathurin Serious Game
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
August 9, 2024 (Anticipated)
Study Completion Date
August 9, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PLANI-REV
Arm Type
Experimental
Arm Description
Persons with schizophrenia who will benefit from the fifteen weekly sessions of PLANI-REV group program
Arm Title
RELAXATION
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
PLANI-REV
Intervention Description
Cognitive remediation program.
Intervention Type
Other
Intervention Name(s)
RELAXATION
Intervention Description
Stimulation with no cognitive remediation.
Primary Outcome Measure Information:
Title
Efficacy of PLANI-REV : questionnaire scores
Description
the comparison pre/post PLANI-REV of the number of difficulties of daily life using the Profinteg questionnaire
Time Frame
10 months
Secondary Outcome Measure Information:
Title
- Profinteg scores 6 months after PLANI-REV. Number of problematic activities; average score for difficulties of problematic activities.
Description
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
Time Frame
16 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle AMADO, MD
Phone
+33 1 45 65 81 80
Email
i.amado@ch-sainte-anne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie DOROCANT
Phone
+33 1 45 65 77 28
Email
s.dorocant@ch-sainte-anne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle AMADO, MD
Organizational Affiliation
CHSA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier DURANT
City
Etampes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François PETITJEAN, MD
Facility Name
Hopital les Murets
City
La Queue-en-Brie
ZIP/Postal Code
94510
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier QUENZER, MD
Facility Name
Centre Hospitalier Sainte Anne
City
Paris
ZIP/Postal Code
75674
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle AMADO, MD
Email
i.amado@ch-sainte-anne.fr
First Name & Middle Initial & Last Name & Degree
Sylvie DOROCANT
Email
s.dorocant@ch-sainte-anne.fr
Facility Name
Centre Hospitalier Guillaume Régnier
City
Rennes
ZIP/Postal Code
35703
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David LEVOYER, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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