Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia (IMPACTRCS)

February 13, 2024 updated by: Hôpital le Vinatier
Neurocognitive deficits are frequent with people suffering from schizophrenia. Unlike positive symptoms, cognitive deficits are not reduced with antipsychotic medication. They can be very disabling, especially for social and professional rehabilitation. Cognitive deficits can concern primary processes such as attention or more integrative processes. Social cognition is also massively altered. As a consequence, decision making is often altered with the presence of the 'jumping to conclusion' (JTC) phenomenon. People that jump to conclusion are making decisions without having the necessary information to be sure of their judgment. In addition, people suffering from schizophrenia also present differences in cerebral activity. For instance, the P300 involved in executive processes appears later and with a smaller amplitude. Many cognitive remediation programs have been created to overcome these deficits. Their efficiency has been proved. However, their effects on cerebral activity have not been studied extensively in literature, especially concerning decision making changes. The present project will use a cognitive remediation program centered on social decision making to test its efficiency on JTC and the potential changes in cerebral activity it can induce. This program, inspired by the SCIT (Social Cognition and Interaction Technique) will be based on 10 sessions (1 each week). Participants will be tested before and after remediation/control group with 3 experimental tasks. Cerebral activity will be measured with an EEG cap. They will also undergo a neuropsychological evaluation and a symptomatology evaluation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Among cognitive deficits associated to schizophrenia, the jumping to conclusion bias is a frequent consequence of the decision making process alteration. This bias is characterized by a fast decision making when probabilistic judgments would be necessar.

Cognitive remediation aims at reducing the impact of cognitive deficits. The program that will be used in the present study focuses on the jump to conclusion bias. In schizophrenia, the positive impact of programs targeting such a bias, and more generally social cognition, has already been shown in numerous studies. However, despite the fact that jumping to conclusion is one of the main goals of these programs, their effects on decision making are poorly investigated in literature.

The program should impact decision making and reduce the jumping to conclusion bias. The benefits will probably be linked with a change in the P300 signal. They will probably appear earlier and with bigger amplitudes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Rhône
      • Lyon, Rhône, France, 69006
        • centre de réhabilitation - Hôpital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • People suffering from schizophrenia given the DSM-5
  • People aged from 18 to 45 years old
  • French mother tongue
  • Medicated with Aripiprazole
  • Medication unchanged in the last month
  • Stable symptomatology
  • People consenting to the research.

Exclusion Criteria:

  • Recent addiction (tabacco excluded)
  • Neurologic disorders (vascular disorders, neurodegenerative disorders, infections…)
  • Somatic medication having cerebral impact (such as corticoids)
  • Pregnant women, guardianship people.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive remediation arm
Participants will be enrolled in a cognitive remediation group. The program will last 10 weeks and be composed of 10 participants. This program is based on strategy learning and its aim is to reduce the jumping to conclusion phenomenon.
Behavioral: Cognitive remediation
10 sessions dealing with emotion recognition, jumping to conclusion, attributional style.program lasts 10 weeks
Active Comparator: Control group
Participants will be enrolled in an information control group. They will receive information about psychosocial rehabilitation and recovery process. The program lasts 10 weeks.
Behavioral: psychosocial rehabilitation
10 sessions dealing psychosocial rehabilitation, neuropsychological evaluation, stigmatization, recovery process and severe mental disorders in general.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Jumping to the conclusion
Time Frame: 12 weeks
The primary outcome will be modification before and after intervention of the correct response percentage. It is obtained by measuring the amplitude of the waves P300 and N200 of the electroencephalogram.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Warwick-Edinburg mental well-being (WEMWBS)
Time Frame: 12 weeks
The outcome measure of mental well-being will be the score of scale modification before and after intervention. It is a questionnaire that includes 14 items.
12 weeks
The positive and the negative symptoms (PANNS)
Time Frame: 12 weeks
The measure of the cognitive fonctioning will be the modification before and after intervention of the score obtained at the proposed neuropsychological evaluation ( excecutive, attentional and social)
12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hôpital le Vinatier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: FRANCK Nicolas, Professor, CH 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-A00813-54

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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