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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Remediation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of the difference in neurocognitive data between patients and controls | Tracking down the alteration in neurocognitive abilities, evaluated with the Brief Assessment of Cognition in Schizophrenia (BACS) (standardized score 0-4) | through study completion, an average of 2.5 years |
| Analysis of the difference in sociocognitive data between patients and controls | Tracking down the alteration in sociocognitive abilities, evaluated with the Picture sequencing task (PST) (score 0-56) | through study completion, an average of 2.5 years |
| Analysis of the difference in pragmatic data between patients and controls | Tracking down the alteration in pragmatic abilities, evaluated with Assessment of Pragmatic Abilities and Cognitive Substrates (APACS brief) (score 0-1) | through study completion, an average of 2.5 years |
| Analysis of the difference in language data between patients and controls | Tracking down the alteration in language abilities, evaluated with AWechsler Vocabulary task (score 0-66) | through study completion, an average of 2.5 years |
| Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording | 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 | through study completion, an average of 2.5 years |
| Analysis of the impact of neuropsychological and electrophysiological measures on quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of psychopathology | Evaluate psychopathology with the Positive and Negative Syndrome scale (PANSS) (score 30-210) | through study completion, an average of 2.5 years |
| Evaluate the efficacy of a rehabilitative training in restoring neurocognitive abilities |
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Inclusion Criteria:
Exclusion Criteria:
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50 subjects with schizopnrenia from San Raffaele Hospital (Milan) and 50 healthy controls living in Milan
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giulia Agostoni, PsyD, PhD | Contact | 00393938584311 | agostoni.giulia@hsr.it |
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| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D012917 | Social Adjustment |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000072466 | Cognitive Remediation |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Evaluate the impact of neuropsychological and electrophysiological measures on quality of life, measured with the Quality of life scale (QLS) (score 0-126)
| through study completion, an average of 2.5 years |
| Analysis of the impact of neuropsychological and electrophysiological measures on community Integration | Evaluate the impact of neuropsychological and electrophysiological measures on community Integration, measured with the Community Integration measure (CIM) (score 10-50) | through study completion, an average of 2.5 years |
| Analysis of the impact of neuropsychological and electrophysiological measures on social connectedness | Evaluate the impact of neuropsychological and electrophysiological measures on social connectedness, measured with the Social Connectedness scale (SCS-R) (score 20-120) | 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) |
| through study completion, an average of 2.5 years |
| Evaluate the efficacy of a rehabilitative training in restoring sociocognitive abilities | Test the improvement in sociocognitive abilities, evaluated with the Picture sequencing task (PST) (score 0-56) | through study completion, an average of 2.5 years |
| Evaluate the efficacy of a rehabilitative training in restoring pragmatic abilities | Test the improvement in pragmatic abilities, evaluated with the Assessment of Pragmatic Abilities and Cognitive Substrates (APACS) (score 0-1) | through study completion, an average of 2.5 years |
| Evaluate the efficacy of a rehabilitative training in restoring language abilities | Test the improvement in language abilities, evaluated with the Wechsler Vocabulary task (score 0-66) | through study completion, an average of 2.5 years |
| Evaluate the efficacy of a rehabilitative training in restoring quality of life | Test the improvement of quality of life, measured with the Quality of life scale (QLS) (score 0-126) | through study completion, an average of 2.5 years |
| Evaluate the efficacy of a rehabilitative training in restoring Community Integration | Test the improvement of Community Integration, measured with the Community Integration measure (CIM) (score 10-50) | through study completion, an average of 2.5 years |
| Evaluate the efficacy of a rehabilitative training in restoring Social Connectedness | Test the improvement of Social Connectedness, measured with the Social Connectedness scale (SCS-R) (score 20-120) | through study completion, an average of 2.5 years |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |