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

NCT04011774 | Unknown

• 1 other identifier: D17-P025
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• - Profinteg scores 6 months after PLANI-REV. Number of problematic activities; average score for difficulties of problematic activities.

  16 months

Study Arms (2)

PLANI-REV

EXPERIMENTAL

Persons with schizophrenia who will benefit from the fifteen weekly sessions of PLANI-REV group program

Other: PLANI-REV

RELAXATION

ACTIVE COMPARATOR

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

Interventions

PLANI-REV OTHER

Cognitive remediation program.

PLANI-REV

RELAXATION OTHER

Stimulation with no cognitive remediation.

RELAXATION

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (4)

Centre Hospitalier DURANT

Étampes, France

RECRUITING

Hopital les Murets

La Queue-en-Brie, 94510, France

RECRUITING

Centre Hospitalier Sainte Anne

Paris, 75674, France

RECRUITING

Centre Hospitalier Guillaume Régnier

Rennes, 35703, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Isabelle AMADO, MD

  CHSA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle AMADO, MD

CONTACT

+33 1 45 65 81 80; i.amado@ch-sainte-anne.fr

Sylvie DOROCANT

CONTACT

+33 1 45 65 77 28; s.dorocant@ch-sainte-anne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: July 8, 2019
• Study Start: October 9, 2018
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: December 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)