French Source-monitoring Task

NCT ID: NCT04237155

Last Updated: 2022-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2024-02-01

Brief Summary

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Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Source-monitoring processes are usually studied using experimental behavioral tasks. These tasks, which are very heterogeneous, are not all available in French and, for the most part, cannot be used in neuroimaging protocols.

The aim of this project is to develop an experimental task which allows the measurement of source-monitoring performances, and which is adapted to neuroimaging protocols in a French-speaking population.

Detailed Description

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The study will include 2 steps: 1) validation of the verbal material necessary for the creation of the source-monitoring task and 2) testing the task.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

For step 1, two populations of participants: 30 healthy volunteers and 30 patients with schizophrenia will have to complete a verbal material scoring questionnaire. For step 2, two populations of participants: 30 healthy volunteers and 30 patients with schizophrenia will have to complete the source-monitoring task which will be created from step 1 as well as the task of reference (Brunelin et al., 2008).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy controls involved in step 1

30 healthy individuals will complete a verbal material scoring questionnaire

Group Type OTHER

Questionnaire

Intervention Type OTHER

Subjects will complete a verbal material scoring questionnaire

Patients with schizophrenia involved in step 1

30 patients with schizophrenia will complete a verbal material scoring questionnaire

Group Type OTHER

Questionnaire

Intervention Type OTHER

Subjects will complete a verbal material scoring questionnaire

Healthy controls involved in step 2

30 healthy individuals will complete the source-monitoring task which will be created from step 1 as well as the task of reference

Group Type OTHER

Cognitive tests

Intervention Type OTHER

Subjects will complete two source-monitoring tasks: the source-monitoring task which will be created from step 1 as well as the task of reference

Patients with schizophrenia involved in step 2

30 patients with schizophrenia will complete the source-monitoring task which will be created from step 1 as well as the task of reference

Group Type OTHER

Cognitive tests

Intervention Type OTHER

Subjects will complete two source-monitoring tasks: the source-monitoring task which will be created from step 1 as well as the task of reference

Interventions

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Questionnaire

Subjects will complete a verbal material scoring questionnaire

Intervention Type OTHER

Cognitive tests

Subjects will complete two source-monitoring tasks: the source-monitoring task which will be created from step 1 as well as the task of reference

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and Women aged between 18 and 45
* Having given their written informed consent
* Native French speakers
* Normal or corrected-to-normal vision
* Education level greater than or equal to 8 (in years)
* For the healthy control group, no history of previous diagnosed psychiatric disorders (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM5), absence of first-degree relatives diagnosed with spectrum disorder schizophrenia and bipolar disorder (DSM).
* For the schizophrenia patients group, meeting the DSM5 criteria for schizophrenia.

Exclusion Criteria

* Do not consent to be included in the study
* History of hearing impairments
* People who cannot read
* Presence of neurological or somatic diseases
* Being under tutorship or curatorship
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier le Vinatier

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lydie Sartelet

Role: CONTACT

0437915531 ext. +33

Facility Contacts

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Marine Mondino

Role: primary

0437915565 ext. +33

Jérôme Brunelin

Role: backup

0437915297 ext. +33

Other Identifiers

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2019-A02549-48

Identifier Type: -

Identifier Source: org_study_id

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