- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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?
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Joy El KHOURY
- Telefonnummer: +330437915534
- E-post: joy.el-khoury@inserm.fr
Studera Kontakt Backup
- Namn: Méline Devaluez, PhD
- E-post: meline.devaluez@ch-le-vinatier.fr
Studieorter
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Bron, Frankrike, 69678
- CH le Vinatier
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Huvudutredare:
- Frédéric HAESEBAERT, MD, PhD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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"Faux Pas" test total score
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Hinting Task
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-A02057-42
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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