French Source-monitoring Task (SOUMO)

March 23, 2022 updated by: Hôpital le Vinatier

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69678
        • Recruiting
        • Centre Hospitalier Le Vinatier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy controls involved in step 1
30 healthy individuals will complete a verbal material scoring questionnaire
Other: Questionnaire
Subjects will complete a verbal material scoring questionnaire
Other: Patients with schizophrenia involved in step 1
30 patients with schizophrenia will complete a verbal material scoring questionnaire
Other: Questionnaire
Subjects will complete a verbal material scoring questionnaire
Other: 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
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
Other: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Source-monitoring performances
Time Frame: one day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital le Vinatier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2020

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02549-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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