Clinical trial NCT04033978: Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia
Official title: Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Cognitive remediation
Jumping to Conclusion
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Jumping to the conclusion
timeFrame: 12 weeks
Secondary outcomes:
measure: Warwick-Edinburg mental well-being (WEMWBS)
timeFrame: 12 weeks
measure: The positive and the negative symptoms (PANNS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lyon
country: France
facility: centre de réhabilitation - Hôpital le Vinatier
state: Rhône
Study officials:
affiliation: CH Le Vinatier
name: FRANCK Nicolas, Professor
role: PRINCIPAL_INVESTIGATOR
References: