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Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia (IMPACTRCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04033978
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : October 25, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Cognitive remediation Behavioral: psychosocial rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel 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
Estimated Study Start Date : October 28, 2019
Estimated Primary Completion Date : March 5, 2022
Estimated Study Completion Date : March 5, 2023

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04033978

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Contact: BON Laura, Psychologue 04 26 73 85 32 ext +33
Contact: VIAL Véronique 04.37915531 ext +33

Sponsors and Collaborators
Hôpital le Vinatier
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Principal Investigator: FRANCK Nicolas, Professor CH Le Vinatier

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Responsible Party: Hôpital le Vinatier Identifier: NCT04033978     History of Changes
Other Study ID Numbers: 2019-A00813-54
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hôpital le Vinatier:
Cognitive remediation
Jumping to Conclusion
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders