French Source-monitoring Task

Schizophrenia Clinical Trial

— SOUMO  

Official title:

Development of a Source-monitoring Task in French Adapted to Neuroimaging Protocols

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04237155
• Other study ID #: 2019-A02549-48
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2022
• Source: Hôpital le Vinatier
• Contact: Lydie Sartelet
• Phone: 0437915531
• Email: lydie.sartelet[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Questionnaire
Subjects will complete a verbal material scoring questionnaire
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier le Vinatier	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Source-monitoring performances	Performances (calculated as the number of accurate source responses and the number of errors) obtained at the new source-monitoring task and at the source-monitoring task of reference (Brunelin et al., 2006).	one day