Schizophenia DisorderCRHESONCT06869616
CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles
An observational study of Schizophenia Disorder, run by IRCCS San Raffaele.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophenia Disorder
- What is being tested?
- Cognitive Remediation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 subjects with schizopnrenia from San Raffaele Hospital (Milan) and 50 healthy controls living in Milan
Who may be able to join
- Age between 18 and 65 years
- Diagnosis of Schizophrenia according to DSM V criteria
- Ability to provide informed consent
Who cannot join
- Intellectual disability
- Neurological disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Schizophenia Disorder
- Being tested
- Cognitive Remediation
- Keywords
- electrophysiology, metaphor comprehension, language disorder, social functioning
- Medical subject headings
- Language Disorders, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RemediationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: through study completion, an average of 2.5 years
Secondary outcomes (8)
Evaluation of psychopathology
Evaluate psychopathology with the Positive and Negative Syndrome scale (PANSS) (score 30-210)
Measured: through study completion, an average of 2.5 years
Evaluate the efficacy of a rehabilitative training in restoring neurocognitive abilities
Test the improvement in neurocognitive abilities, evaluated with the Brief Assessment of Cognition in Schizophrenia (BACS) (standardized score 0-4)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: through study completion, an average of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophenia DisorderStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulia Agostoni, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869616
- Sponsor's protocol ID
- CRHESO
- Acronym
- CRHESO
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles
- ClinicalTrials.gov ID
- NCT06869616
- Acronym / sponsor ID
- CRHESO / CRHESO
- Conditions
- Schizophenia Disorder
- Keywords
- electrophysiology, metaphor comprehension, language disorder, social functioning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia Group | – | Other: Cognitive RemediationWe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 subjects with schizopnrenia from San Raffaele Hospital (Milan) and 50 healthy controls living in Milan
Key inclusion criteria (3 listed)
- Age between 18 and 65 years
- Diagnosis of Schizophrenia according to DSM V criteria
- Ability to provide informed consent
Key exclusion criteria (2 listed)
- Intellectual disability
- Neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Remediation10 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. | Other | Schizophrenia Group |
Primary outcome
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)
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)
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)
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)
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
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)
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)
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)
8 secondary outcomes
Evaluation of psychopathology
Time frame: 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
Evaluate the efficacy of a rehabilitative training in restoring sociocognitive abilities
Time frame: 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
Evaluate the efficacy of a rehabilitative training in restoring language abilities
Time frame: 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
Evaluate the efficacy of a rehabilitative training in restoring Community Integration
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophenia Disorder, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giulia Agostoni, PsyD, PhD (00393938584311, agostoni.giulia@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the difference in neurocognitive data between patients and controls (time frame: through study completion, an average of 2.5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.