Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia (IMPACTRCS)
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive remediation
psychosocial rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cognitive remediation, Jumping to Conclusion
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.
Sites / Locations
- centre de réhabilitation - Hôpital le VinatierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive remediation arm
Control group
Arm Description
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.
Participants will be enrolled in an information control group. They will receive information about psychosocial rehabilitation and recovery process. The program lasts 10 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04033978
Brief Title
Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia
Acronym
IMPACTRCS
Official Title
Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
March 5, 2023 (Anticipated)
Study Completion Date
March 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Cognitive remediation, Jumping to Conclusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
The participants don't know the select group.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive remediation arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants will be enrolled in an information control group. They will receive information about psychosocial rehabilitation and recovery process. The program lasts 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation
Intervention Description
10 sessions dealing with emotion recognition, jumping to conclusion, attributional style.program lasts 10 weeks
Intervention Type
Behavioral
Intervention Name(s)
psychosocial rehabilitation
Intervention Description
10 sessions dealing psychosocial rehabilitation, neuropsychological evaluation, stigmatization, recovery process and severe mental disorders in general.
Primary Outcome Measure Information:
Title
Jumping to the conclusion
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Warwick-Edinburg mental well-being (WEMWBS)
Description
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.
Time Frame
12 weeks
Title
The positive and the negative symptoms (PANNS)
Description
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)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BON Laura, Psychologue
Phone
04 26 73 85 32
Ext
+33
Email
laura.bon@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
VIAL Véronique
Phone
04.37915531
Ext
+33
Email
_recherche@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANCK Nicolas, Professor
Organizational Affiliation
CH Le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
centre de réhabilitation - Hôpital le Vinatier
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69006
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Nicolas, PUPH
Phone
+33 (0)4 26 23 76 11
Email
nicolas.franck@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Gaudelus Baptiste
Phone
+33 (0)4 26 23 76 11
Email
baptiste.gaudelus@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Franck Nicolas
12. IPD Sharing Statement
Learn more about this trial
Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia
We'll reach out to this number within 24 hrs