Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia

NCT ID: NCT04033978

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-17
• Study Completion Date: 2023-06-17

Brief Summary

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.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive remediation

Intervention Type: BEHAVIORAL

10 sessions dealing with emotion recognition, jumping to conclusion, attributional style.program lasts 10 weeks

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.

Group Type: ACTIVE_COMPARATOR

psychosocial rehabilitation

Intervention Type: BEHAVIORAL

10 sessions dealing psychosocial rehabilitation, neuropsychological evaluation, stigmatization, recovery process and severe mental disorders in general.

Interventions

Cognitive remediation

10 sessions dealing with emotion recognition, jumping to conclusion, attributional style.program lasts 10 weeks

Intervention Type: BEHAVIORAL

psychosocial rehabilitation

10 sessions dealing psychosocial rehabilitation, neuropsychological evaluation, stigmatization, recovery process and severe mental disorders in general.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

FRANCK Nicolas, Professor

Role: PRINCIPAL_INVESTIGATOR

CH Le Vinatier

Locations

centre de réhabilitation - Hôpital le Vinatier

Lyon, Rhône, France

Countries

France

Other Identifiers

2019-A00813-54

Identifier Type: -

Identifier Source: org_study_id