NCT06484387

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 8, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

June 26, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

social interactioninterpersonal synchronization

Outcome Measures

Primary Outcomes (2)

  • interpersonal synchronization

    synchronization between body movements of two interacting partners

    4x6 minutes

  • intrapersonal synchronization

    synchronization between voice and body movements of one individual

    4x6 minutes

Secondary Outcomes (2)

  • correlation between primary outcomes and individuals with schizophrenia medications

    4x6 minutes

  • correlation between synchronization and willingness to continue the interaction

    4x6 minutes

Study Arms (2)

dyad schizophrenia and interacting partner

EXPERIMENTAL

social interaction between an individual with a diagnosis of schizophrenia and his interacting partner

Behavioral: Social interaction

dyad healthy subject and interacting partner

EXPERIMENTAL

social interaction between a healthy subject and his interacting partner

Behavioral: Social interaction

Interventions

Participants are required to speak to one another. Participants are given various topics of conversation.

dyad healthy subject and interacting partnerdyad schizophrenia and interacting partner

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of schizophrenia according to the DSM-V
  • being able to read, speak and understand french
  • giving eclaired consent

You may not qualify if:

  • 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 :
  • being able to read, speak and understand french
  • giving eclaired consent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34000, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Central Study Contacts

Delphine Capdevielle, Pr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

November 8, 2024

Primary Completion

November 8, 2025

Study Completion

November 8, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations