Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia

NCT04033978 | Terminated

• 1 other identifier: 2019-A00813-54
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Cognitive remediation; Jumping to Conclusion

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (2)

• Warwick-Edinburg mental well-being (WEMWBS)

  12 weeks

• The positive and the negative symptoms (PANNS)

  12 weeks

Study Arms (2)

Cognitive remediation arm

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Cognitive remediation BEHAVIORAL

10 sessions dealing with emotion recognition, jumping to conclusion, attributional style.program lasts 10 weeks

Cognitive remediation arm

psychosocial rehabilitation BEHAVIORAL

10 sessions dealing psychosocial rehabilitation, neuropsychological evaluation, stigmatization, recovery process and severe mental disorders in general.

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Recent addiction (tabacco excluded)
• Neurologic disorders (vascular disorders, neurodegenerative disorders, infections…)
• Somatic medication having cerebral impact (such as corticoids)
• Pregnant women, guardianship people.

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

centre de réhabilitation - Hôpital le Vinatier

Lyon, Rhône, 69006, France

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Remediation; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• FRANCK Nicolas, Professor

  CH Le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants don't know the select group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 26, 2019
• Study Start: December 17, 2019
• Primary Completion: June 13, 2023
• Study Completion: June 17, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

FR (1)