CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles

NCT ID: NCT06869616

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2028-01-01

Brief Summary

CRHESO aims at overcoming the considerable burden of mental disorders, which affects both psychosocial well-being and societal welfare, through a multidisciplinary and integrated approach to explore and remediate dimensions affecting social outcome.

Detailed Description

Social functioning is fundamental for human adaptation, relationships, and psychological well-being. Schizophrenia, a severe psychiatric disorder, is one of the leading causes of disability worldwide and presents significant challenges in social interactions for those affected, increasing the risk of isolation and marginalization. The CRHESO project aims to analyze the factors influencing social functioning. The main hypothesis is that social functioning depends on various components, including neurocognitive, sociocognitive, and language abilities, along with their electrophysiological markers. CRHESO seeks to characterize neuropsychophysiological profiles (combining neuropsychological and electrophysiological data) to better understand social outcomes in individuals with schizophrenia and in healthy subjects.

The investigators will address the following objectives:

• Primary Objective: Primary Objective: To disentangle social functioning complexity in schizophrenia and healthy controls by characterizing neuropsychophysiological profiles linked to levels of social disruption
• Secondary Objective: To improve factors associated with social outcome and explore changes in neuropsychophysiological markers The investigators will enroll 50 schizophrenic patients and 50 healthy controls.

Participants will undergo an initial visit with a specialist psychiatrist who will verify that their conditions meet the criteria required by the study. Then, subjects will be tested for metaphor comprehension, as well as for the other variables included in the study, and the electrical brain activity will be registered through a 128 channel EEG.

To test if the factors associated with social dysfunction in schizophrenia can be restored, we will propose to subjects with schizophrenia to participate in a rehabilitative training. Those who choose not to undergo the training will only participate in the cross-sectional study, while 10 patients who decide to participate in the training will undergo cognitive remediation training (Cognitive Remediation), already published and demonstrated to be feasible for patients with schizophrenia.

In the check-up visits (i.e., after the training), the patients enrolled in the treatment group, will be tested for metaphor comprehension, as well as for the other variables included in the study, and the electrical brain activity will be registered through a 128 channel EEG.

Conditions

Schizophenia Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Schizophrenia Group

We will enroll 50 patients selected according to the presence of Schizophrenia diagnosis (DSM V criteria), which will be tested for metaphor comprehension, as well as for the other variables included in the study, and the electrical brain activity will be registered through a 128 channel EEG.

Among these, a subgroup of 10 subjects will undergo a cognitive remediation training (Cognitive Remediation), already published and demonstrated to be feasible for patients with schizophrenia. Specifically, it consists of 15 sessions of 45 minutes each, including computerized domain-specific neurocognitive exercises aimed at training specific cognitive areas known to be impaired in schizophrenia.

Cognitive Remediation

Intervention Type: OTHER

10 patients will undergo a rehabilitative training (Cognitive Remediation), already published and demonstrated to be feasible for patients with schizophrenia. This program includes domain-specific neurocognitive exercises aimed at training specific cognitive areas known to be impaired in schizophrenia. The treatment plan includes 15 45-minutes sessions.

Healthy controls

50 healthy subjects, as control sample, that will be tested for metaphor comprehension, as well as for the other variables included in the study, and the electrical brain activity will be registered through a 128 channel EEG.

No interventions assigned to this group

Interventions

Cognitive Remediation

10 patients will undergo a rehabilitative training (Cognitive Remediation), already published and demonstrated to be feasible for patients with schizophrenia. This program includes domain-specific neurocognitive exercises aimed at training specific cognitive areas known to be impaired in schizophrenia. The treatment plan includes 15 45-minutes sessions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 65 years
• Diagnosis of Schizophrenia according to DSM V criteria
• Ability to provide informed consent

Exclusion Criteria

• Intellectual disability
• Neurological disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Giulia Agostoni

PsyD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Giulia Agostoni, PsyD, PhD

Role: CONTACT

agostoni.giulia@hsr.it

00393938584311

Other Identifiers

CRHESO

Identifier Type: -

Identifier Source: org_study_id