- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07602712
Using Illusions to Boost Social Cognition (SOLLUSIONS)
Socio-cognitive Benefits of Exposure to Visual Illusions in Patients With Psychotic Disorders
This study aims to explore whether the observation of complex visual objects can help improve social cognition in people living with psychotic disorders. Social cognition refers to the ability to understand what others think, feel, or intend, and plays a key role in social relationships and daily interactions.
Main questions this study aims to answer:
- Does dyadic exposure to complex visual objects improve mental state attribution, as measured by the Faux Pas Test?
- Does the intervention enhance related domains of social cognition, including implicit intention inference (Hinting Task), interpretation of complex interactions (Movie for the Assessment of Social Cognition, MASC), and reduction of hostile attribution biases (Ambiguous Intentions Hostility Questionnaire, AIHQ)?
- Are improvements maintained after one month, and do patients who receive the intervention later (waitlist group) show the same benefits once exposed?
Panoramica dello studio
Stato
Descrizione dettagliata
This study is a randomized, controlled, monocentric trial evaluating a novel sensory-motor rehabilitation approach for social cognition. The study is based on the hypothesis that perception is interpretative and viewpoint-dependent, and that realizing this through concrete experience could generalize to higher-level cognitive processes required for social understanding.
Participants will attend three visits and complete questionnaires and tasks that assess social understanding before and after the activity, and again one month later.
Two groups will take part: one completing the workshop shortly after inclusion, and one completing it after a delay, allowing comparison over time. Participants will be randomized in one condition.
This research does not involve medication. It consists of simple tasks such as observing and describing visual stimuli, followed by a facilitated discussion.
Neuropsychological tests and questionnaires will be used to measure changes over time.
Expected impact: By inducing concrete perspective-shifts, the intervention aims to improve mentalizing, reduce egocentric biases, and strengthen interpretation of social cues. This bottom-up sensory-motor approach may overcome limitations of classical cognitive remediation programs by promoting deep experiential learning rather than top-down instruction.
If effective, the method may support long-term social reintegration, psychosocial functioning, and inspire wider clinical applications due to its low cost, ease of deployment, and strong ecological engagement.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Joy El KHOURY
- Numero di telefono: +330437915534
- Email: joy.el-khoury@inserm.fr
Backup dei contatti dello studio
- Nome: Méline Devaluez, PhD
- Email: meline.devaluez@ch-le-vinatier.fr
Luoghi di studio
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Bron, Francia, 69678
- CH Le Vinatier
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Investigatore principale:
- Frédéric HAESEBAERT, MD, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Aged 18 to 40 years
- Fluent French speaker
- Has provided written informed consent
- For individuals under guardianship (curatorship): inclusion is permitted if the curator is available to assist or advise when needed.
- Established diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or brief psychotic disorder according to theDiagnostic and statistical manual of mental disorders (DSM-5-TR) criteria
- Presence of social cognition impairment, defined by:subjective complaint reported by the participant or identified by care teams regarding difficulties in social interaction and clinical confirmation of observable difficulties (e.g., social withdrawal, misinterpretation of others' intentions, inappropriate social behaviour)
- Membership or entitlement to a social security plan
Exclusion Criteria:
- Clinical state incompatible with participation in group-based activities (e.g., severe psychomotor agitation, severe behavioural disturbance)
- Concurrent participation in another social cognition remediation program
- Diagnosis of intellectual disability
- Insufficient comprehension of French for verbal interaction and test completion
- Significant change in psychotropic medication within the past month
- Uncorrectable visual impairment preventing participation
- Pregnant women
- Individuals under full guardianship (tutorship)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Immediate intervention
Participants receive the visual-perception session shortly after baseline assessment.
They complete neurocognitive and social cognition tests before exposure, immediately after, and again at one-month follow-up.
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A guided session of approximately 45 minutes. The core rehabilitation tool consists of multiple-perspective illusion boxes. Each participant stands on one side of the box and perceives a different shape than their partner. The session unfolds in 3 structured phases:
The session is followed by a short structured discussion with a psychologist focused on perspective-taking and interpretation of social cues. |
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Comparatore attivo: Delayed Intervention (Wait-list Control)
Participants complete the same assessments as Arm 1 but receive the intervention only after a waiting period.
This arm allows comparison between natural progression and workshop effects prior to exposure.
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A guided session of approximately 45 minutes.
The core rehabilitation tool consists of multiple-perspective illusion boxes.
Each participant stands on one side of the box and perceives a different shape than their partner.
The session unfolds in 3 structured phases: 1.
For each illusion : Participants observe objects silently and draw what they see.
2. Perspective confrontation + Card selection: Drawings and interpretation cards are exchanged and discussed.
3. Perspective switching : Participants swap positions to reveal the alternative visual interpretation.
The session is followed by a short structured discussion with a psychologist focused on perspective-taking and interpretation of social cues.
Delivered after a delay following baseline assessment.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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"Faux Pas" test total score
Lasso di tempo: Change from pre to post intervention (up to 3 hours)
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Change from pre to post intervention (up to 3 hours)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hinting Task
Lasso di tempo: Change from pre to post intervention (up to 3 hours)
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Change from pre to post intervention (up to 3 hours)
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MASC performance
Lasso di tempo: Change from pre intervention to follow-up session (up to a month and a half)
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Number of correct responses Score range 0 - 45 Minimum (0) : No correct mental state inference Maximum (45) : All mental states correctly inferred
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Change from pre intervention to follow-up session (up to a month and a half)
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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- Schizofrenia
- Psicosi
- Rimedio cognitivo
- Cognizione sociale
- Metacognizione
- Teoria della mente
- Interazione sociale
- Compito di suggerimento
- Mentalizzazione
- Perspective-Taking
- Visual Illusions
- Viewpoint Illusions
- Bottom-Up Intervention
- Sensorimotor Rehabilitation
- Faux Pas Test
- Rehabilitation in Psychosis
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025-A02057-42
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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