CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Remediation.
- Who it may be relevant to
- Registry conditions: Schizophenia Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Analysis of the difference in neurocognitive data between patients and controls [Time frame: 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]
- Analysis of the difference in pragmatic data between patients and controls [Time frame: 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 difficulties in metaphor comprehension via task during electrophysiological recording [Time frame: 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]
- Analysis of the impact of neuropsychological and electrophysiological measures on community Integration [Time frame: 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]
Secondary outcome measures (8)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06869616 · CRHESO