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

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: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Cognitive remediation; Behavioral: psychosocial rehabilitation

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: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BON Laura, Psychologue; Phone Number: +33 04 26 73 85 32; Email: laura.bon@ch-le-vinatier.fr
• Study Contact Backup: Name: VIAL Véronique; Phone Number: +33 04.37915531; Email: _recherche@ch-le-vinatier.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Jumping to the conclusion	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

Outcome Measure	Measure Description	Time Frame
Warwick-Edinburg mental well-being (WEMWBS)	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)	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

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: FRANCK Nicolas, Professor, CH Le Vinatier

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): June 17, 2023

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Cognitive remediation; Jumping to Conclusion
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID 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