- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06484387
Study of Intra- and Interpersonal Multimodal Synchronizations in a Social Interaction in Individuals with a Diagnosis of Schizophrenia. (ENHANCER1)
Study of Multimodal Intra- and Interpersonal Synchronizations in Social Interaction in Individuals with a Diagnosis of Schizophrenia.
The aim of this study is to precisely identify deficits in intra- and interpersonal multimodal synchronizations during social interaction in individuals with schizophrenia (ISZ). During a social interaction, individuals use both visual and auditory channels to construct their discourse. The auditory channel encompasses the semantics and prosody of the speech, while the visual channel describes the entirety of non-verbal gestures (e.g., facial expressions, body movements). Prosody and non-verbal gestures are essential elements for the speaker. By accompanying speech, they contribute to the planning and conceptualization of the utterance and enhance its communicative power. For the listener, prosody and non-verbal gestures are also used to provide sensory feedback to the speaker.
Several studies have shown the existence of intrapersonal and interpersonal synchronizations of prosody and non-verbal gestures during interaction. These synchronizations are associated with numerous social benefits (e.g., increased mutual appreciation and quality of interaction). However, certain mental disorders, such as schizophrenia, exhibit deficits in non-verbal behaviors that can impair these synchronizations and the associated social benefits. We hypothetized that interaction with individuals with a daignosis of schizophrenia will be associated with deficits in intra and interpersonal synchronization.
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Delphine Capdevielle, Pr
- Phone Number: 0467339702
- Email: d-capdevielle@chu-montpellier.fr
Study Contact Backup
- Name: Mathilde Parisi
- Phone Number: 0632935910
- Email: mathilde.parisi99@gmail.com
Study Locations
-
-
-
Montpellier, France, 34000
- Recruiting
- Montpellier University Hospital
-
Contact:
- Delphine CAPDEVIELLE
-
Contact:
- Mathilde Parisi
- Phone Number: +33467339727
- Email: mathilde.parisi99@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Individuals with a diagnosis of schizophrenia :
Inclusion Criteria:
- diagnosis of schizophrenia according to the DSM-V
- being able to read, speak and understand french
- giving eclaired consent
Exclusion Criteria:
- history of head trauma
- history of neurological conditions (epilespsy, multiple sclerosis, parkinson's disease, amyotrophic lateral sclerosis, huntington's disease, stroke)
- substance use
- pregnant women
Healthy controls :
Inclusion Criteria:
- being able to read, speak and understand french
- giving eclaired consent
Exclusion Criteria:
- diagnosis of psychosis
- history of head trauma
- history of neurological conditions (epilespsy, multiple sclerosis, parkinson's disease, amyotrophic lateral sclerosis, huntington's disease, stroke)
- substance use
- pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: dyad schizophrenia and interacting partner
social interaction between an individual with a diagnosis of schizophrenia and his interacting partner
|
Participants are required to speak to one another.
Participants are given various topics of conversation.
|
|
Experimental: dyad healthy subject and interacting partner
social interaction between a healthy subject and his interacting partner
|
Participants are required to speak to one another.
Participants are given various topics of conversation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
interpersonal synchronization
Time Frame: 4x6 minutes
|
synchronization between body movements of two interacting partners
|
4x6 minutes
|
|
intrapersonal synchronization
Time Frame: 4x6 minutes
|
synchronization between voice and body movements of one individual
|
4x6 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
correlation between primary outcomes and individuals with schizophrenia medications
Time Frame: 4x6 minutes
|
4x6 minutes
|
|
correlation between synchronization and willingness to continue the interaction
Time Frame: 4x6 minutes
|
4x6 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL22_0408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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