Planning Your Everyday Life in Virtual Reality : a Study in Schizophrenia; (PlaniRev)
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|ClinicalTrials.gov Identifier: NCT04011774|
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
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.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Persons with schizophrenia who will benefit from the fifteen weekly sessions of PLANI-REV group program
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.
Stimulation with no cognitive remediation.
- 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
- - 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
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
|Contact: Isabelle AMADO, MD||+33 1 45 65 81 firstname.lastname@example.org|
|Contact: Sylvie DOROCANT||+33 1 45 65 77 email@example.com|
|Centre Hospitalier DURANT||Recruiting|
|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 firstname.lastname@example.org|
|Contact: Sylvie DOROCANT email@example.com|
|Centre Hospitalier Guillaume Régnier||Recruiting|
|Rennes, France, 35703|
|Contact: David LEVOYER, MD|
|Principal Investigator:||Isabelle AMADO, MD||CHSA|