Clinical trial NCT06869616: CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles
Official title: CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Schizophenia Disorder
Keywords: electrophysiology
metaphor comprehension
language disorder
social functioning
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 subjects with schizopnrenia from San Raffaele Hospital (Milan) and 50 healthy controls living in Milan

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.

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

Primary outcomes:
measure: Analysis of the difference in neurocognitive data between patients and controls
timeFrame: through study completion, an average of 2.5 years
measure: Analysis of the difference in sociocognitive data between patients and controls
timeFrame: through study completion, an average of 2.5 years
measure: Analysis of the difference in pragmatic data between patients and controls
timeFrame: through study completion, an average of 2.5 years
measure: Analysis of the difference in language data between patients and controls
timeFrame: through study completion, an average of 2.5 years
measure: Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording
timeFrame: through study completion, an average of 2.5 years
measure: Analysis of the impact of neuropsychological and electrophysiological measures on quality of life
timeFrame: through study completion, an average of 2.5 years
measure: Analysis of the impact of neuropsychological and electrophysiological measures on community Integration
timeFrame: through study completion, an average of 2.5 years
measure: Analysis of the impact of neuropsychological and electrophysiological measures on social connectedness
timeFrame: through study completion, an average of 2.5 years
Secondary outcomes:
measure: Evaluation of psychopathology
timeFrame: through study completion, an average of 2.5 years
measure: Evaluate the efficacy of a rehabilitative training in restoring neurocognitive abilities
timeFrame: through study completion, an average of 2.5 years
measure: Evaluate the efficacy of a rehabilitative training in restoring sociocognitive abilities
timeFrame: through study completion, an average of 2.5 years
measure: Evaluate the efficacy of a rehabilitative training in restoring pragmatic abilities
timeFrame: through study completion, an average of 2.5 years
measure: Evaluate the efficacy of a rehabilitative training in restoring language abilities
timeFrame: through study completion, an average of 2.5 years
measure: Evaluate the efficacy of a rehabilitative training in restoring quality of life
timeFrame: through study completion, an average of 2.5 years
measure: Evaluate the efficacy of a rehabilitative training in restoring Community Integration
timeFrame: through study completion, an average of 2.5 years
measure: Evaluate the efficacy of a rehabilitative training in restoring Social Connectedness
timeFrame: through study completion, an average of 2.5 years
Other outcomes:
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