SchizophreniaENHANCER1NCT06484387
Study of Intra- and Interpersonal Multimodal Synchronizations in a Social Interaction in Individuals with a Diagnosis of Schizophrenia.
A study testing Social interaction in people with Schizophrenia, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Social interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2024to 8 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosis of schizophrenia according to the DSM-V
- being able to read, speak and understand french
- giving eclaired consent
- being able to read, speak and understand french
- giving eclaired consent
Who cannot join
- 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 :
- diagnosis of psychosis
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Montpellier University Hospital
Montpellier, 34000
Mathilde Parisi, +33467339727, mathilde.parisi99@gmail.com
Delphine CAPDEVIELLE
About this study
Official title: 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.
Read the detailed description
This study includes a pre-inclusion interview followed by a visit to the university hospital (CHU) lasting about 2 hours (including a break). During the visit, the patient participates in an experimental protocol consisting of two parts. In the first part, the patient will be paired with an interaction partner, and the two participants will engage in four distinct conversational tasks, including getting to know each other, free discussions, structured dialogues, and emotional interactions. In the second part, the participants will answer several questionnaires and perform neuropsychological tests in collaboration with an experimenter
- Conditions
- Schizophrenia
- Being tested
- Social interaction
- Keywords
- social interaction, interpersonal synchronization
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social interactionBehavioural
Participants are required to speak to one another. Participants are given various topics of conversation.
| Study group | Role | What they receive |
|---|---|---|
| dyad schizophrenia and interacting partner | Experimental | social interaction between an individual with a diagnosis of schizophrenia and his interacting partner Receives: Behavioral: Social interaction |
| dyad healthy subject and interacting partner | Experimental | social interaction between a healthy subject and his interacting partner Receives: Behavioral: Social interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
interpersonal synchronization
synchronization between body movements of two interacting partners
Measured: 4x6 minutes
intrapersonal synchronization
synchronization between voice and body movements of one individual
Measured: 4x6 minutes
Secondary outcomes (2)
correlation between primary outcomes and individuals with schizophrenia medications
Measured: 4x6 minutes
correlation between synchronization and willingness to continue the interaction
Measured: 4x6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start8 Nov 2024
- Primary completion8 Nov 2025 (estimated)
- Study completion8 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Euromov Digital Health in Motion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484387
- Sponsor's protocol ID
- RECHMPL22_0408
- Acronym
- ENHANCER1
- Status last verified
- Dec 2024
- First submitted
- 26 Jun 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Multimodal Intra- and Interpersonal Synchronizations in Social Interaction in Individuals with a Diagnosis of Schizophrenia.
- ClinicalTrials.gov ID
- NCT06484387
- Acronym / sponsor ID
- ENHANCER1 / RECHMPL22_0408
- Conditions
- Schizophrenia
- Keywords
- social interaction, interpersonal synchronization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Euromov Digital Health in Motion
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 8 Nov 2025 (estimated)
- Study completion
- 8 Nov 2025 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study includes a pre-inclusion interview followed by a visit to the university hospital (CHU) lasting about 2 hours (including a break). During the visit, the patient participates in an experimental protocol consisting of two parts. In the first part, the patient will be paired with an interaction partner, and the two participants will engage in four distinct conversational tasks, including getting to know each other, free discussions, structured dialogues, and emotional interactions. In the second part, the participants will answer several questionnaires and perform neuropsychological tests in collaboration with an experimenter
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dyad schizophrenia and interacting partner | Experimental | Behavioral: Social interactionsocial interaction between an individual with a diagnosis of schizophrenia and his interacting partner |
| dyad healthy subject and interacting partner | Experimental | Behavioral: Social interactionsocial interaction between a healthy subject and his interacting partner |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of schizophrenia according to the DSM-V
- being able to read, speak and understand french
- giving eclaired consent
- being able to read, speak and understand french
- giving eclaired consent
Key exclusion criteria (10 listed)
- 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
- diagnosis of psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social interactionParticipants are required to speak to one another. Participants are given various topics of conversation. | Behavioural | dyad healthy subject and interacting partner, dyad schizophrenia and interacting partner |
Primary outcome
interpersonal synchronization
Time frame: 4x6 minutes
synchronization between body movements of two interacting partners
intrapersonal synchronization
Time frame: 4x6 minutes
synchronization between voice and body movements of one individual
2 secondary outcomes
correlation between primary outcomes and individuals with schizophrenia medications
Time frame: 4x6 minutes
correlation between synchronization and willingness to continue the interaction
Time frame: 4x6 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social interaction in people with Schizophrenia, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine Capdevielle, Pr (0467339702, d-capdevielle@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interpersonal synchronization (time frame: 4x6 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.