CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles

NCT06869616 | Not Yet Recruiting

• 1 other identifier: CRHESO
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophenia Disorder

Keywords

electrophysiology; metaphor comprehension; language disorder; social functioning

Outcome Measures

Primary Outcomes (8)

• 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

  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

Secondary Outcomes (8)

• Evaluation of psychopathology

  through study completion, an average of 2.5 years

• Evaluate the efficacy of a rehabilitative training in restoring neurocognitive abilities

  through study completion, an average of 2.5 years

• Evaluate the efficacy of a rehabilitative training in restoring sociocognitive abilities

  through study completion, an average of 2.5 years

• Evaluate the efficacy of a rehabilitative training in restoring pragmatic abilities

  through study completion, an average of 2.5 years

• Evaluate the efficacy of a rehabilitative training in restoring language abilities

  through study completion, an average of 2.5 years

Study Arms (2)

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.

Other: Cognitive Remediation

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.

Interventions

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.

Schizophrenia Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 subjects with schizopnrenia from San Raffaele Hospital (Milan) and 50 healthy controls living in Milan

You may qualify if:

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

You may not qualify if:

• Intellectual disability
• Neurological disorder

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Language Disorders; Social Adjustment

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Giulia Agostoni, PsyD, PhD

CONTACT

00393938584311; agostoni.giulia@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PsyD, PhD

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 11, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share