NCT04237155

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

January 17, 2020

Last Update Submit

March 23, 2022

Conditions

Keywords

Sorce-monitoring

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Healthy controls involved in step 1

OTHER

30 healthy individuals will complete a verbal material scoring questionnaire

Other: Questionnaire

Patients with schizophrenia involved in step 1

OTHER

30 patients with schizophrenia will complete a verbal material scoring questionnaire

Other: Questionnaire

Healthy controls involved in step 2

OTHER

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

Patients with schizophrenia involved in step 2

OTHER

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

Interventions

Subjects will complete a verbal material scoring questionnaire

Healthy controls involved in step 1Patients with schizophrenia involved in step 1

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

Healthy controls involved in step 2Patients with schizophrenia involved in step 2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier le Vinatier

Bron, 69678, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Surveys and QuestionnairesNeuropsychological Tests

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPsychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 23, 2020

Study Start

February 7, 2020

Primary Completion

February 1, 2023

Study Completion

February 1, 2024

Last Updated

March 24, 2022

Record last verified: 2022-03

Locations