CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles

Not yet recruiting

• Conditions: Schizophenia Disorder

• Registration Number: NCT06869616
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study First Submitted: 2025-02-28
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Study Start: 2025-05-01
• Primary Completion: 2027-11-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of the difference in pragmatic data between patients and controls	through study completion, an average of 2.5 years	Tracking down the alteration in pragmatic abilities, evaluated with Assessment of Pragmatic Abilities and Cognitive Substrates (APACS brief) (score 0-1)
Analysis of the difference in sociocognitive data between patients and controls	through study completion, an average of 2.5 years	Tracking down the alteration in sociocognitive abilities, evaluated with the Picture sequencing task (PST) (score 0-56)
Analysis of the difference in language data between patients and controls	through study completion, an average of 2.5 years	Tracking down the alteration in language abilities, evaluated with AWechsler Vocabulary task (score 0-66)
Analysis of the difference in neurocognitive data between patients and controls	through study completion, an average of 2.5 years	Tracking down the alteration in neurocognitive abilities, evaluated with the Brief Assessment of Cognition in Schizophrenia (BACS) (standardized score 0-4)
Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording	through study completion, an average of 2.5 years	Exploring the difference in the neurological correlates (via electrophysiological recording technique) between patients and controls. We will measure event-related potential (ERP) after the stimulus presentation
Analysis of the impact of neuropsychological and electrophysiological measures on quality of life	through study completion, an average of 2.5 years	Evaluate the impact of neuropsychological and electrophysiological measures on quality of life, measured with the Quality of life scale (QLS) (score 0-126)
Analysis of the impact of neuropsychological and electrophysiological measures on community Integration	through study completion, an average of 2.5 years	Evaluate the impact of neuropsychological and electrophysiological measures on community Integration, measured with the Community Integration measure (CIM) (score 10-50)
Analysis of the impact of neuropsychological and electrophysiological measures on social connectedness	through study completion, an average of 2.5 years	Evaluate the impact of neuropsychological and electrophysiological measures on social connectedness, measured with the Social Connectedness scale (SCS-R) (score 20-120)

Secondary Outcome Measures

Name	Time	Method
Evaluation of psychopathology	through study completion, an average of 2.5 years	Evaluate psychopathology with the Positive and Negative Syndrome scale (PANSS) (score 30-210)
Evaluate the efficacy of a rehabilitative training in restoring neurocognitive abilities	through study completion, an average of 2.5 years	Test the improvement in neurocognitive abilities, evaluated with the Brief Assessment of Cognition in Schizophrenia (BACS) (standardized score 0-4)
Evaluate the efficacy of a rehabilitative training in restoring sociocognitive abilities	through study completion, an average of 2.5 years	Test the improvement in sociocognitive abilities, evaluated with the Picture sequencing task (PST) (score 0-56)
Evaluate the efficacy of a rehabilitative training in restoring pragmatic abilities	through study completion, an average of 2.5 years	Test the improvement in pragmatic abilities, evaluated with the Assessment of Pragmatic Abilities and Cognitive Substrates (APACS) (score 0-1)
Evaluate the efficacy of a rehabilitative training in restoring language abilities	through study completion, an average of 2.5 years	Test the improvement in language abilities, evaluated with the Wechsler Vocabulary task (score 0-66)
Evaluate the efficacy of a rehabilitative training in restoring quality of life	through study completion, an average of 2.5 years	Test the improvement of quality of life, measured with the Quality of life scale (QLS) (score 0-126)
Evaluate the efficacy of a rehabilitative training in restoring Community Integration	through study completion, an average of 2.5 years	Test the improvement of Community Integration, measured with the Community Integration measure (CIM) (score 10-50)
Evaluate the efficacy of a rehabilitative training in restoring Social Connectedness	through study completion, an average of 2.5 years	Test the improvement of Social Connectedness, measured with the Social Connectedness scale (SCS-R) (score 20-120)