CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles
ConditionSchizophenia Disorder
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 65 years
Diagnosis of Schizophrenia according to DSM V criteria
Ability to provide informed consent
Disqualifiers
Intellectual disability
Neurological disorder
Trial population
50 subjects with schizopnrenia from San Raffaele Hospital (Milan) and 50 healthy controls living in Milan
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Cognitive Remediation
Other intervention10 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Schizophrenia Group1 intervention
Group B: Healthy controls0 interventions
Trial outcomes
Primary outcomes
1
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)
Time frame
through study completion, an average of 2.5 years2
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)
Time frame
through study completion, an average of 2.5 years3
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)
Time frame
through study completion, an average of 2.5 years4
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)
Time frame
through study completion, an average of 2.5 yearsSecondary outcomes
1
Evaluation of psychopathology
Evaluate psychopathology with the Positive and Negative Syndrome scale (PANSS) (score 30-210)
Time frame
through study completion, an average of 2.5 years2
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)
Time frame
through study completion, an average of 2.5 years3
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)
Time frame
through study completion, an average of 2.5 years4
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)
Time frame
through study completion, an average of 2.5 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: