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French Source-monitoring Task (SOUMO)

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire
Cognitive tests
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia focused on measuring Sorce-monitoring

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier le VinatierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Healthy controls involved in step 1

Patients with schizophrenia involved in step 1

Healthy controls involved in step 2

Patients with schizophrenia involved in step 2

Arm Description

30 healthy individuals will complete a verbal material scoring questionnaire

30 patients with schizophrenia will complete a verbal material scoring questionnaire

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 17, 2020
Last Updated
March 23, 2022
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT04237155
Brief Title
French Source-monitoring Task
Acronym
SOUMO
Official Title
Development of a Source-monitoring Task in French Adapted to Neuroimaging Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Sorce-monitoring

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls involved in step 1
Arm Type
Other
Arm Description
30 healthy individuals will complete a verbal material scoring questionnaire
Arm Title
Patients with schizophrenia involved in step 1
Arm Type
Other
Arm Description
30 patients with schizophrenia will complete a verbal material scoring questionnaire
Arm Title
Healthy controls involved in step 2
Arm Type
Other
Arm Description
30 healthy individuals will complete the source-monitoring task which will be created from step 1 as well as the task of reference
Arm Title
Patients with schizophrenia involved in step 2
Arm Type
Other
Arm Description
30 patients with schizophrenia will complete the source-monitoring task which will be created from step 1 as well as the task of reference
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Subjects will complete a verbal material scoring questionnaire
Intervention Type
Other
Intervention Name(s)
Cognitive tests
Intervention Description
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
Primary Outcome Measure Information:
Title
Source-monitoring performances
Description
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).
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lydie Sartelet
Phone
0437915531
Ext
+33
Email
lydie.sartelet@ch-le-vinatier.fr
Facility Information:
Facility Name
Centre Hospitalier le Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine Mondino
Phone
0437915565
Ext
+33
Email
marine.mondino@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Jérôme Brunelin
Phone
0437915297
Ext
+33
Email
jerome.brunelin@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Marine Mondino
First Name & Middle Initial & Last Name & Degree
Frédéric Haesebaert
First Name & Middle Initial & Last Name & Degree
Jerome Brunelin

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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French Source-monitoring Task

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