IMPACTRCS: Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia

Sponsor
Hôpital le Vinatier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04033978
Collaborator
(none)
60
1
2
50.6
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive remediation
  • Behavioral: psychosocial rehabilitation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Single (Participant)
Masking Description:
The participants don't know the select group.
Primary Purpose:
Treatment
Official Title:
Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia
Actual Study Start Date :
Dec 17, 2019
Anticipated Primary Completion Date :
Mar 5, 2023
Anticipated Study Completion Date :
Mar 5, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 centre de réhabilitation - Hôpital le Vinatier Lyon Rhône France 69006

Sponsors and Collaborators

  • Hôpital le Vinatier

Investigators

  • Principal Investigator: FRANCK Nicolas, Professor, CH Le Vinatier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT04033978
Other Study ID Numbers:
  • 2019-A00813-54
First Posted:
Jul 26, 2019
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hôpital le Vinatier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022