Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia (IMPACTRCS)
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|ClinicalTrials.gov Identifier: NCT04033978|
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : October 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Cognitive remediation Behavioral: psychosocial rehabilitation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment|
|Masking Description:||The participants don't know the select group.|
|Official Title:||Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia|
|Estimated Study Start Date :||October 28, 2019|
|Estimated Primary Completion Date :||March 5, 2022|
|Estimated Study Completion Date :||March 5, 2023|
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.
- Jumping to the conclusion [ Time Frame: 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.
- Warwick-Edinburg mental well-being (WEMWBS) [ Time Frame: 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) [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033978
|Contact: BON Laura, Psychologue||04 26 73 85 32 ext +firstname.lastname@example.org|
|Contact: VIAL Véronique||04.37915531 ext +email@example.com|
|Principal Investigator:||FRANCK Nicolas, Professor||CH Le Vinatier|