Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia

Not Applicable

Terminated

• Conditions: Schizophrenia
• Interventions: Behavioral: Cognitive remediation; Behavioral: psychosocial rehabilitation

• Registration Number: NCT04033978
• Lead Sponsor: Hôpital le Vinatier

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.

Study Timeline

• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-26
• Study Start: 2019-12-17
• Primary Completion: 2023-06-13
• Study Completion: 2023-06-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive remediation arm	Cognitive remediation	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.
Control group	psychosocial rehabilitation	Participants will be enrolled in an information control group. They will receive information about psychosocial rehabilitation and recovery process. The program lasts 10 weeks.

Primary Outcome Measures

Name	Time	Method
Jumping to the conclusion	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.

Secondary Outcome Measures

Name	Time	Method
Warwick-Edinburg mental well-being (WEMWBS)	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.
The positive and the negative symptoms (PANNS)	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)

Trial Locations

Locations (1)

centre de réhabilitation - Hôpital le Vinatier; 🇫🇷 Lyon, Rhône, France