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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011774
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Other: PLANI-REV Other: RELAXATION Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: PLANning Your Every Day Life I Virtual REality : a Study Schizophrenia. Mathurin Serious Game
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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.




Primary Outcome Measures :
  1. Efficacy of PLANI-REV : questionnaire scores [ Time Frame: 10 months ]
    the comparison pre/post PLANI-REV of the number of difficulties of daily life using the Profinteg questionnaire


Secondary Outcome Measures :
  1. - Profinteg scores 6 months after PLANI-REV. Number of problematic activities; average score for difficulties of problematic activities. [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011774


Contacts
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Contact: Isabelle AMADO, MD +33 1 45 65 81 80 i.amado@ch-sainte-anne.fr
Contact: Sylvie DOROCANT +33 1 45 65 77 28 s.dorocant@ch-sainte-anne.fr

Locations
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France
Centre Hospitalier DURANT Recruiting
Etampes, France
Contact: François PETITJEAN, MD         
Hopital les Murets Recruiting
La Queue-en-Brie, France, 94510
Contact: Olivier QUENZER, MD         
Centre Hospitalier Sainte Anne Recruiting
Paris, France, 75674
Contact: Isabelle AMADO, MD       i.amado@ch-sainte-anne.fr   
Contact: Sylvie DOROCANT       s.dorocant@ch-sainte-anne.fr   
Centre Hospitalier Guillaume Régnier Recruiting
Rennes, France, 35703
Contact: David LEVOYER, MD         
Sponsors and Collaborators
Centre Hospitalier St Anne
Investigators
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Principal Investigator: Isabelle AMADO, MD CHSA
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Responsible Party: Centre Hospitalier St Anne
ClinicalTrials.gov Identifier: NCT04011774    
Other Study ID Numbers: D17-P025
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders