CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles (CRHESO)

March 5, 2025 updated by: Giulia Agostoni, IRCCS San Raffaele
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the difference in neurocognitive data between patients and controls
Time Frame: 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)
through study completion, an average of 2.5 years
Analysis of the difference in sociocognitive data between patients and controls
Time Frame: 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)
through study completion, an average of 2.5 years
Analysis of the difference in pragmatic data between patients and controls
Time Frame: 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)
through study completion, an average of 2.5 years
Analysis of the difference in language data between patients and controls
Time Frame: through study completion, an average of 2.5 years
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
Time Frame: 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
through study completion, an average of 2.5 years
Analysis of the impact of neuropsychological and electrophysiological measures on quality of life
Time Frame: 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)
through study completion, an average of 2.5 years
Analysis of the impact of neuropsychological and electrophysiological measures on community Integration
Time Frame: 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)
through study completion, an average of 2.5 years
Analysis of the impact of neuropsychological and electrophysiological measures on social connectedness
Time Frame: 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)
through study completion, an average of 2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of psychopathology
Time Frame: through study completion, an average of 2.5 years
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
Time Frame: 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
Time Frame: 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)
through study completion, an average of 2.5 years
Evaluate the efficacy of a rehabilitative training in restoring pragmatic abilities
Time Frame: 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)
through study completion, an average of 2.5 years
Evaluate the efficacy of a rehabilitative training in restoring language abilities
Time Frame: through study completion, an average of 2.5 years
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
Time Frame: 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)
through study completion, an average of 2.5 years
Evaluate the efficacy of a rehabilitative training in restoring Community Integration
Time Frame: 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)
through study completion, an average of 2.5 years
Evaluate the efficacy of a rehabilitative training in restoring Social Connectedness
Time Frame: 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)
through study completion, an average of 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRHESO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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