The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them

• Conditions: Schizophrenia; Psychosis
• Interventions: Behavioral: PragmaCom

• Registration Number: NCT06375902
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique

Detailed Description

The investigators will address the following objectives:

* Primary Objective: Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique

* Secondary Objectives: 1) Evaluate the interactions between performances in metaphor comprehension and individual differences in psychopathology, cognition, ToM and functioning; 2) Test if the altered neurophysiological patterns associated to the fragility of metaphor comprehension in schizophrenia can be restored through a rehabilitative training

The investigators will enroll 32 schizophrenic patients and 32 healthy subjects as control sample.

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.

In the check-up visits (i.e., after the training) the following data will be collected:

* Scores relating to cognitive, pragmatic (understanding of metaphors), theory of mind and global functioning performance scores

* EEG recordings related to the process of understanding metaphors

* Scores on scales that evaluate psychopathological severity

Study Timeline

• Study First Submitted: 2024-03-15
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Study Start: 2024-07-12
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

For patients:

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

For healthy controls:

• Age between 18 and 65 years
• Ability to provide informed consent
• Absence of psychiatric pathologies
• Ability to speak Italian

Exclusion Criteria

For patients:

• Intellectual disability
• Neurological disorder

For healthy controls:

• Presence of psychiatric pathologies
• Difficulties in speaking Italian

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Schizophrenia group	PragmaCom	We will enroll 32 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. Patients will be assigned either to a rehabilitative training (PragmaCom), or to a standard rehabilitative program to test if the altered neurophysiological patterns associated to the fragility of metaphor comprehension in schizophrenia can be restored.

Primary Outcome Measures

Name	Time	Method
Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording	through study completion, an average of 2 years	Exploring the difference in the neurological correlates (via electrophysiological recording technique) between patients and controls. Electrophysiological indexes that will be evaluated are event-related potential after the stimulus presentation.
Tracking down the difficulties in metaphor comprehension via a behavioural task	through study completion, an average of 2 years	Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia compared to healthy controls across different metaphor types through the Physical and mental metaphor task (PMM) (range values 0-28, higher scores mean a better outcome).

Secondary Outcome Measures

Name	Time	Method
Evaluation of functioning	through study completion, an average of 2 years	Evaluate functioning, with the Quality of life scale (QLS) (range score 0-126, higher scores mean a better outcome).
Evaluation of Theory of Mind	through study completion, an average of 2 years	Evaluate Theory of Mind with the Picture sequencing task (PST) (range score 0-56, higher scores mean a better outcome).
Evaluation of psychopathology	through study completion, an average of 2 years	Evaluate psychopathology with the Positive and Negative Syndrome scale (PANSS) (range values 30-210, higher scores mean a worse outcome).
Evaluation of cognition	through study completion, an average of 2 years	Evaluate cognition in schizophrenia with the Brief assessement of cognition in schizophrenia (BACS) (range total score 0-1, higher scores mean a better outcome).
Evaluate the efficacy of a rehabilitative training in restoring metaphor comprehension ability	through study completion, an average of 2 years	Test te improvement of metaphor comprehension, evaluated with the Physical and mental metaphor task (PMM) (range values 0-28, higher scores mean a better outcome).

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milan, Italy