PsychosisDISCOURSE-NBNCT06978803
HYEEG Discourse in Psychosis: A Neurobehavioural Study
An observational study of Psychosis and Schizophrenia Disorders, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
This multimodal study explores the mechanisms underlying social dysfunction in individuals with schizophrenia. It focuses on the relationship between disorganized communication and social interaction, aiming to identify measurable markers of disorganized communication and link them to clinical symptoms and social… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Schizophrenia Disorders
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jan 2024to 31 Dec 2026
- Phase
- Observational
- 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
Study population: Patients with psychosis will be recruited from the following Douglas Mental Health University Institute areas: l'Étape Outpatient Clinic, Assertive Community Treatment Clinics, Intensive Psychosocial Rehab Clinic, and the Prevention and Early Intervention Program for Psychosis (PEPP) clinics in CIUSSS de l'ouest-de-L'île-de-Montréal, in association with the Centre for Youth Mental Health at the Douglas. Healthy Control participants will be recruited from the Greater Montreal Area using online study advertisements (Facebook, Kijiji, Twitter) and research study posters placed on bulletin boards.
Who may be able to join
- English or French-speaking participants (as dyads matched for language preference).
- Ages 18-60 years.
- Patients meeting the operational criteria for schizophrenia or schizoaffective illness as previously diagnosed by their treating psychiatrist, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria (Zipursky et al., 2020).
- Patients with less than 5 years of illness onset, based on the time of starting treatment with antipsychotic medication.
Who cannot join
- Participants should not have a primary diagnosis of Alcohol or Drug abuse or addiction (however, co-morbid substance abuse with a primary diagnosis of psychotic disorder is not an exclusion criterion).
- Participants should not have a severe medical disorder that would explain psychotic symptoms.
- Participants should not have a past or current history of a primary neurological disorder that can affect speech output
- Participants with IQ below 70 or a concurrent pervasive developmental disorder (e.g., autism) will also be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
Emmanuel Olarewaju, PhD Candidate, 5147616131 ext. 2005, emmanuel.olarewaju@mail.mcgill.ca
Lena Palaniyappan, MD, PhD
About this study
This multimodal study explores the mechanisms underlying social dysfunction in individuals with schizophrenia. It focuses on the relationship between disorganized communication and social interaction, aiming to identify measurable markers of disorganized communication and link them to clinical symptoms and social functioning.
Key Research Questions:
Read more
How do neural and behavioural synchrony contribute to social impairments in schizophrenia?
What roles do interbrain synchrony, motor imitation, reaction time, and verbal coherence play in disorganized communication?
Participants will:
- Engage in structured and semi-structured real-time social interactions while undergoing dual-brain electroencephalogram (EEG) hyperscanning to measure neural and behavioural activity.
- Perform nonverbal tasks such as motor imitation and reaction time assessments to investigate coordination and behavioural synchrony patterns.
- Participate in a clinical interview that evaluates verbal production, thought coherence, and speech organization.
By combining these assessments, the study aims to advance our understanding of how social and communication impairments manifest in schizophrenia. The findings will contribute to developing improved diagnostic tools and targeted interventions, ultimately supporting patients in achieving better social functioning and quality of life.
Read the detailed description
INTRODUCTION
Schizophrenia, often associated with psychosis, is a severe mental disorder that profoundly impacts individuals, families, and society, diminishing quality of life and well-being globally. Disorganized communication-a hallmark feature of schizophrenia-is characterized by impairments in speech production, gesture-speech coordination, and motor behaviours that disrupt the ability to convey and interpret meaning in social contexts. These deficits profoundly undermine interpersonal relationships and social connectedness, creating barriers to meaningful social engagement. The impact of these challenges is particularly acute among marginalized populations, who face additional systemic obstacles such as stigma, reduced access to healthcare, and limited social support networks.
The early onset of psychosis, typically during late adolescence or early adulthood, coincides with a critical developmental period marked by heightened neuroplasticity. Social preferences, communication patterns, and adaptive behaviours are formed during this period. This developmental window is particularly vulnerable to disruptions in social interactions, which can derail neurobehavioural trajectories and contribute to long-term social dysfunction. Understanding how disorganized communication emerges and persists during this critical window is essential for designing early interventions to mitigate its effects.
Social disconnection-the breakdown of interpersonal connectivity and adaptability-is likely rooted in disruptions to the underlying neurobehavioural dynamics that facilitate coordinated interpersonal interactions. These dynamics include synchrony in speech, movement, and neural activity, which are crucial for effective social functioning. Despite significant advancements in mental health research, the specific neural and behavioural underpinnings of disorganized communication remain poorly understood, particularly in their relationship to broader social dysfunction in schizophrenia.
Addressing these challenges requires advanced tools capable of capturing the dynamic and reciprocal processes underlying social interactions. Real-time electroencephalogram (EEG) hyperscanning offers a robust method for studying interbrain synchrony, a critical interpersonal dynamic essential for coordinated social behaviour. This technique allows for the simultaneous recording of brain activity from two individuals engaged in reciprocal sensorimotor interactions, such as cooperative imitation. By analyzing patterns of synchrony and desynchrony in interbrain activity and associated bodily dynamics, EEG hyperscanning provides a detailed framework for examining the mechanisms underlying nonverbal communication and its disruptions.
This study integrates a speech elicitation protocol with standardized transcription methods and natural language processing (NLP) techniques developed by the Diverse International Scientific Consortium for Research in Thought, Language and Communication in Psychosis group. Additionally, it incorporates a validated motor imitation protocol from prior research with healthy participants. By combining EEG hyperscanning data with detailed analyses of verbal and nonverbal behaviours, the study seeks to identify disruptions in cooperative imitation and their links to speech disorganization, providing new insights into the mechanisms of disorganized communication.
This research aims to elucidate the mechanisms underlying disorganized communication by linking neural synchrony to verbal coherence, motor synchrony, and other neurobehavioural responses. These findings aim to inform the development of targeted early interventions that address both the behavioural and neural dimensions of disorganized communication in individuals with psychosis.
RATIONALE
The frontal and temporoparietal brain regions play critical roles in selective attention, inhibitory control, and social cognition. In schizophrenia, disruptions in neural synchronization between these regions-particularly within the alpha (8-12 Hz), beta (13-30 Hz), and gamma (30-100 Hz) frequency bands-are well-documented. Impaired functional connectivity between the prefrontal cortex and temporoparietal regions may contribute to maladaptive, self-focused attention, impairing the processing and integration of external social cues.
Specific dysregulations are hypothesized to underlie these deficits: alpha-band disruptions weaken attentional filtering, beta-band abnormalities impair sustained cognitive control, and gamma-band deficits disrupt the integration of social and perceptual information. These disruptions are expected to create an imbalance between internal and external processing, reducing neural coherence and phase synchronization during social exchanges. This breakdown in neural and behavioural coordination is hypothesized to manifest as neurobehavioural markers of disorganized communication-a hallmark feature of schizophrenia.
SPECIFIC HYPOTHESES
- Impairments in Inhibition-Based Imitation: Patients with schizophrenia will exhibit significant impairments in inhibition-based imitation compared to automatic imitation, as the former requires higher cognitive control. These impairments are expected to reflect deficits in executive function, particularly the ability to selectively suppress automatic responses.
- Correlation Between Imitation and Speech Disorganization: Difficulties in inhibition-based imitation will positively correlate with the severity of speech disorganization. Speech disorganization will be measured through clinical evaluations, structured interviews, and natural language processing (NLP) analyses, highlighting shared neural mechanisms underlying executive function and social communication.
- Reduced Interbrain Synchrony:
Interbrain synchrony during interpersonal coordination, assessed using EEG hyperscanning and behavioural analysis, will be significantly reduced in patients compared to healthy controls. This reduction is expected to reflect disruptions in neural oscillations critical for effective social interaction.
MULTIMODAL ANALYSES AND FUTURE DIRECTIONS
This research employs multimodal exploratory analyses to investigate the relationships between interbrain synchrony, bodily activity measures, and conversational speech variables, such as verbal coherence and semantic similarity. These analyses will also explore how these measures relate to symptom severity, providing a comprehensive understanding of their interplay.
By quantifying the effect sizes of these relationships, the study aims to establish foundational evidence for the development of larger-scale research. The results are expected to inform the refinement of experimental protocols, identify robust biomarkers of social dysfunction, and guide the design of targeted early interventions for individuals with psychosis.
- Conditions
- Psychosis, Schizophrenia Disorders
- Keywords
- hyperscanning eeg, psychosis, imitation tasks, interbrain synchrony, motor imitation, motor behaviour, speech disorganization, natural language processing
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | 1. English or French-speaking participants (as dyads matched for language preference). 2. Ages 18-60 years. 3. No diagnosis of schizophrenia or schizoaffective illness based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria. | |
| Patients | 1. English or French-speaking participants (as dyads matched for language preference). 2. Ages 18-60 years. 3. Patients meeting the operational criteria for schizophrenia or schizoaffective illness as previously diagnosed by their treating psychiatrist, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria. 4. Patients with less than 5 years of illness onset, based on the time of starting treatment with antipsychotic medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-brain phase synchronization using Phase Locking Index via hyperscanning during communication
Using oscillatory and time-frequency analyses of electroencephalography (EEG) hyperscanning data, inter-brain synchronization will be calculated via phase locking value for both patients and control subjects. This value will be related to: (1) verbal data from clinical interviews analyzed using Natural Language Processing techniques, including sentiment analysis to assess emotional tone, coherence classification to evaluate logical flow, and semantic similarity analysis (2) nonverbal measures such as motor synchrony, imitation accuracy, and reaction time.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start16 Jan 2024
- Primary completion22 Oct 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Palaniyappan, Douglas Mental Health University Institute
- Investigators
- Lena Palaniyappan, MD, PhD, Principal investigator, Douglas Mental Health University Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978803
- Sponsor's protocol ID
- 2023-595
- Acronym
- DISCOURSE-NB
- Status last verified
- Nov 2024
- First submitted
- 13 Jan 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We propose to use a clinical linguistic archiving system called the TalkBank (https://www.talkbank.org/) for data sharing purposes. TalkBank registry/database is located at Carnegie Mellon University, Pittsburgh, Pennsylvania-USA. Several filters are used to de-identify the recorded speech data before storage in the databank. Firstly, the Discourse protocol explicitly avoids using proper nouns and names/addresses. Second, the transcribed data is checked, and any proper names are replaced by common names (e.g., 'McGill' will be changed to 'University') or bleeped out (for audio data). If requested, we will play back the recorded responses to check if the participant is comfortable with the degree of anonymity. Identifying demodemographics will not be stored alongside the speech data to reduce triangulation. Finally, sharing is controlled by password protection, and a re-review is done to remove identifying information before sharing is initiated.
Publications
Rybarczyk, B., Social and Occupational Functioning Assessment Scale (SOFAS), in Encyclopedia of Clinical Neuropsychology, J.S. Kreutzer, J. DeLuca, and B. Caplan, Editors. 2011, Springer New York: New York, NY. p. 2313-2313.
Liechti S, Capodilupo G, Opler DJ, Opler M, Yang LH. A Developmental History of the Positive and Negative Syndrome Scale (PANSS). Innov Clin Neurosci. 2017 Dec 1;14(11-12):12-17.
PubMed 29410932Tang SX, Kriz R, Cho S, Park SJ, Harowitz J, Gur RE, Bhati MT, Wolf DH, Sedoc J, Liberman MY. Natural language processing methods are sensitive to sub-clinical linguistic differences in schizophrenia spectrum disorders. NPJ Schizophr. 2021 May 14;7(1):25. doi: 10.1038/s41537-021-00154-3.
PubMed 33990615Morgan SE, Diederen K, Vertes PE, Ip SHY, Wang B, Thompson B, Demjaha A, De Micheli A, Oliver D, Liakata M, Fusar-Poli P, Spencer TJ, McGuire P. Natural Language Processing markers in first episode psychosis and people at clinical high-risk. Transl Psychiatry. 2021 Dec 13;11(1):630. doi: 10.1038/s41398-021-01722-y.
PubMed 34903724Liddle PF, Ngan ET, Caissie SL, Anderson CM, Bates AT, Quested DJ, White R, Weg R. Thought and Language Index: an instrument for assessing thought and language in schizophrenia. Br J Psychiatry. 2002 Oct;181:326-30. doi: 10.1192/bjp.181.4.326.
PubMed 12356660Kinreich S, Djalovski A, Kraus L, Louzoun Y, Feldman R. Brain-to-Brain Synchrony during Naturalistic Social Interactions. Sci Rep. 2017 Dec 6;7(1):17060. doi: 10.1038/s41598-017-17339-5.
PubMed 29213107Dumas G, Nadel J, Soussignan R, Martinerie J, Garnero L. Inter-brain synchronization during social interaction. PLoS One. 2010 Aug 17;5(8):e12166. doi: 10.1371/journal.pone.0012166.
PubMed 20808907Czeszumski A, Eustergerling S, Lang A, Menrath D, Gerstenberger M, Schuberth S, Schreiber F, Rendon ZZ, Konig P. Hyperscanning: A Valid Method to Study Neural Inter-brain Underpinnings of Social Interaction. Front Hum Neurosci. 2020 Feb 28;14:39. doi: 10.3389/fnhum.2020.00039. eCollection 2020.
PubMed 32180710Carollo A, Esposito G. Hyperscanning literature after two decades of neuroscientific research: A scientometric review. Neuroscience. 2024 Jul 23;551:345-354. doi: 10.1016/j.neuroscience.2024.05.045. Epub 2024 Jun 10.
PubMed 38866073Hirano Y, Uhlhaas PJ. Current findings and perspectives on aberrant neural oscillations in schizophrenia. Psychiatry Clin Neurosci. 2021 Dec;75(12):358-368. doi: 10.1111/pcn.13300. Epub 2021 Oct 29.
PubMed 34558155Geng JJ, Vossel S. Re-evaluating the role of TPJ in attentional control: contextual updating? Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2608-20. doi: 10.1016/j.neubiorev.2013.08.010. Epub 2013 Aug 30.
PubMed 23999082daSilva EB, Wood A. How and Why People Synchronize: An Integrated Perspective. Pers Soc Psychol Rev. 2025 May;29(2):159-187. doi: 10.1177/10888683241252036. Epub 2024 May 21.
PubMed 38770754Liu T, Pelowski M. Clarifying the interaction types in two-person neuroscience research. Front Hum Neurosci. 2014 Apr 30;8:276. doi: 10.3389/fnhum.2014.00276. eCollection 2014. No abstract available.
PubMed 24817848Nowak A, Vallacher RR, Zochowski M, Rychwalska A. Functional Synchronization: The Emergence of Coordinated Activity in Human Systems. Front Psychol. 2017 Jun 13;8:945. doi: 10.3389/fpsyg.2017.00945. eCollection 2017.
PubMed 28659842Koul A, Ahmar D, Iannetti GD, Novembre G. Interpersonal synchronization of spontaneously generated body movements. iScience. 2023 Feb 1;26(3):106104. doi: 10.1016/j.isci.2023.106104. eCollection 2023 Mar 17.
PubMed 36852275
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYEEG Discourse in Psychosis: A Neurobehavioural Study
- ClinicalTrials.gov ID
- NCT06978803
- Acronym / sponsor ID
- DISCOURSE-NB / 2023-595
- Conditions
- Psychosis, Schizophrenia Disorders
- Keywords
- hyperscanning eeg, psychosis, imitation tasks, interbrain synchrony, motor imitation, motor behaviour, speech disorganization, natural language processing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 22 Oct 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 May 2025 (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.
This multimodal study explores the mechanisms underlying social dysfunction in individuals with schizophrenia. It focuses on the relationship between disorganized communication and social interaction, aiming to identify measurable markers of disorganized communication and link them to clinical symptoms and social functioning.
Key Research Questions:
How do neural and behavioural synchrony contribute to social impairments in schizophrenia?
What roles do interbrain synchrony, motor imitation, reaction time, and verbal coherence play in disorganized communication?
Participants will:
- Engage in structured and semi-structured real-time social interactions while undergoing dual-brain electroencephalogram (EEG) hyperscanning to measure neural and behavioural activity.
- Perform nonverbal tasks such as motor imitation and reaction time assessments to investigate coordination and behavioural synchrony patterns.
- Participate in a clinical interview that evaluates verbal production, thought coherence, and speech organization.
By combining these assessments, the study aims to advance our understanding of how social and communication impairments manifest in schizophrenia. The findings will contribute to developing improved diagnostic tools and targeted interventions, ultimately supporting patients in achieving better social functioning and quality of life.
Detailed description
INTRODUCTION
Schizophrenia, often associated with psychosis, is a severe mental disorder that profoundly impacts individuals, families, and society, diminishing quality of life and well-being globally. Disorganized communication-a hallmark feature of schizophrenia-is characterized by impairments in speech production, gesture-speech coordination, and motor behaviours that disrupt the ability to convey and interpret meaning in social contexts. These deficits profoundly undermine interpersonal relationships and social connectedness, creating barriers to meaningful social engagement. The impact of these challenges is particularly acute among marginalized populations, who face additional systemic obstacles such as stigma, reduced access to healthcare, and limited social support networks.
The early onset of psychosis, typically during late adolescence or early adulthood, coincides with a critical developmental period marked by heightened neuroplasticity. Social preferences, communication patterns, and adaptive behaviours are formed during this period. This developmental window is particularly vulnerable to disruptions in social interactions, which can derail neurobehavioural trajectories and contribute to long-term social dysfunction. Understanding how disorganized communication emerges and persists during this critical window is essential for designing early interventions to mitigate its effects.
Social disconnection-the breakdown of interpersonal connectivity and adaptability-is likely rooted in disruptions to the underlying neurobehavioural dynamics that facilitate coordinated interpersonal interactions. These dynamics include synchrony in speech, movement, and neural activity, which are crucial for effective social functioning. Despite significant advancements in mental health research, the specific neural and behavioural underpinnings of disorganized communication remain poorly understood, particularly in their relationship to broader social dysfunction in schizophrenia.
Addressing these challenges requires advanced tools capable of capturing the dynamic and reciprocal processes underlying social interactions. Real-time electroencephalogram (EEG) hyperscanning offers a robust method for studying interbrain synchrony, a critical interpersonal dynamic essential for coordinated social behaviour. This technique allows for the simultaneous recording of brain activity from two individuals engaged in reciprocal sensorimotor interactions, such as cooperative imitation. By analyzing patterns of synchrony and desynchrony in interbrain activity and associated bodily dynamics, EEG hyperscanning provides a detailed framework for examining the mechanisms underlying nonverbal communication and its disruptions.
This study integrates a speech elicitation protocol with standardized transcription methods and natural language processing (NLP) techniques developed by the Diverse International Scientific Consortium for Research in Thought, Language and Communication in Psychosis group. Additionally, it incorporates a validated motor imitation protocol from prior research with healthy participants. By combining EEG hyperscanning data with detailed analyses of verbal and nonverbal behaviours, the study seeks to identify disruptions in cooperative imitation and their links to speech disorganization, providing new insights into the mechanisms of disorganized communication.
This research aims to elucidate the mechanisms underlying disorganized communication by linking neural synchrony to verbal coherence, motor synchrony, and other neurobehavioural responses. These findings aim to inform the development of targeted early interventions that address both the behavioural and neural dimensions of disorganized communication in individuals with psychosis.
RATIONALE
The frontal and temporoparietal brain regions play critical roles in selective attention, inhibitory control, and social cognition. In schizophrenia, disruptions in neural synchronization between these regions-particularly within the alpha (8-12 Hz), beta (13-30 Hz), and gamma (30-100 Hz) frequency bands-are well-documented. Impaired functional connectivity between the prefrontal cortex and temporoparietal regions may contribute to maladaptive, self-focused attention, impairing the processing and integration of external social cues.
Specific dysregulations are hypothesized to underlie these deficits: alpha-band disruptions weaken attentional filtering, beta-band abnormalities impair sustained cognitive control, and gamma-band deficits disrupt the integration of social and perceptual information. These disruptions are expected to create an imbalance between internal and external processing, reducing neural coherence and phase synchronization during social exchanges. This breakdown in neural and behavioural coordination is hypothesized to manifest as neurobehavioural markers of disorganized communication-a hallmark feature of schizophrenia.
SPECIFIC HYPOTHESES
- Impairments in Inhibition-Based Imitation: Patients with schizophrenia will exhibit significant impairments in inhibition-based imitation compared to automatic imitation, as the former requires higher cognitive control. These impairments are expected to reflect deficits in executive function, particularly the ability to selectively suppress automatic responses.
- Correlation Between Imitation and Speech Disorganization: Difficulties in inhibition-based imitation will positively correlate with the severity of speech disorganization. Speech disorganization will be measured through clinical evaluations, structured interviews, and natural language processing (NLP) analyses, highlighting shared neural mechanisms underlying executive function and social communication.
- Reduced Interbrain Synchrony:
Interbrain synchrony during interpersonal coordination, assessed using EEG hyperscanning and behavioural analysis, will be significantly reduced in patients compared to healthy controls. This reduction is expected to reflect disruptions in neural oscillations critical for effective social interaction.
MULTIMODAL ANALYSES AND FUTURE DIRECTIONS
This research employs multimodal exploratory analyses to investigate the relationships between interbrain synchrony, bodily activity measures, and conversational speech variables, such as verbal coherence and semantic similarity. These analyses will also explore how these measures relate to symptom severity, providing a comprehensive understanding of their interplay.
By quantifying the effect sizes of these relationships, the study aims to establish foundational evidence for the development of larger-scale research. The results are expected to inform the refinement of experimental protocols, identify robust biomarkers of social dysfunction, and guide the design of targeted early interventions for individuals with psychosis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –1. English or French-speaking participants (as dyads matched for language preference). 2. Ages 18-60 years. 3. No diagnosis of schizophrenia or schizoaffective illness based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria. |
| Patients | – | –1. English or French-speaking participants (as dyads matched for language preference). 2. Ages 18-60 years. 3. Patients meeting the operational criteria for schizophrenia or schizoaffective illness as previously diagnosed by their treating psychiatrist, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria. 4. Patients with less than 5 years of illness onset, based on the time of starting treatment with antipsychotic medication. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with psychosis will be recruited from the following Douglas Mental Health University Institute areas: l'Étape Outpatient Clinic, Assertive Community Treatment Clinics, Intensive Psychosocial Rehab Clinic, and the Prevention and Early Intervention Program for Psychosis (PEPP) clinics in CIUSSS de l'ouest-de-L'île-de-Montréal, in association with the Centre for Youth Mental Health at the Douglas. Healthy Control participants will be recruited from the Greater Montreal Area using online study advertisements (Facebook, Kijiji, Twitter) and research study posters placed on bulletin boards.
Key inclusion criteria (4 listed)
- English or French-speaking participants (as dyads matched for language preference).
- Ages 18-60 years.
- Patients meeting the operational criteria for schizophrenia or schizoaffective illness as previously diagnosed by their treating psychiatrist, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria (Zipursky et al., 2020).
- Patients with less than 5 years of illness onset, based on the time of starting treatment with antipsychotic medication.
Key exclusion criteria (4 listed)
- Participants should not have a primary diagnosis of Alcohol or Drug abuse or addiction (however, co-morbid substance abuse with a primary diagnosis of psychotic disorder is not an exclusion criterion).
- Participants should not have a severe medical disorder that would explain psychotic symptoms.
- Participants should not have a past or current history of a primary neurological disorder that can affect speech output
- Participants with IQ below 70 or a concurrent pervasive developmental disorder (e.g., autism) will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter-brain phase synchronization using Phase Locking Index via hyperscanning during communication
Time frame: baseline
Using oscillatory and time-frequency analyses of electroencephalography (EEG) hyperscanning data, inter-brain synchronization will be calculated via phase locking value for both patients and control subjects. This value will be related to: (1) verbal data from clinical interviews analyzed using Natural Language Processing techniques, including sentiment analysis to assess emotional tone, coherence classification to evaluate logical flow, and semantic similarity analysis (2) nonverbal measures such as motor synchrony, imitation accuracy, and reaction time.
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 18 May 2025.
- BackgroundRybarczyk, B., Social and Occupational Functioning Assessment Scale (SOFAS), in Encyclopedia of Clinical Neuropsychology, J.S. Kreutzer, J. DeLuca, and B. Caplan, Editors. 2011, Springer New York: New York, NY. p. 2313-2313.
- Background: PubMed 29410932Liechti S, Capodilupo G, Opler DJ, Opler M, Yang LH. A Developmental History of the Positive and Negative Syndrome Scale (PANSS). Innov Clin Neurosci. 2017 Dec 1;14(11-12):12-17.
- Background: PubMed 33990615Tang SX, Kriz R, Cho S, Park SJ, Harowitz J, Gur RE, Bhati MT, Wolf DH, Sedoc J, Liberman MY. Natural language processing methods are sensitive to sub-clinical linguistic differences in schizophrenia spectrum disorders. NPJ Schizophr. 2021 May 14;7(1):25. doi: 10.1038/s41537-021-00154-3.
- Background: PubMed 34903724Morgan SE, Diederen K, Vertes PE, Ip SHY, Wang B, Thompson B, Demjaha A, De Micheli A, Oliver D, Liakata M, Fusar-Poli P, Spencer TJ, McGuire P. Natural Language Processing markers in first episode psychosis and people at clinical high-risk. Transl Psychiatry. 2021 Dec 13;11(1):630. doi: 10.1038/s41398-021-01722-y.
- Background: PubMed 12356660Liddle PF, Ngan ET, Caissie SL, Anderson CM, Bates AT, Quested DJ, White R, Weg R. Thought and Language Index: an instrument for assessing thought and language in schizophrenia. Br J Psychiatry. 2002 Oct;181:326-30. doi: 10.1192/bjp.181.4.326.
- Background: PubMed 29213107Kinreich S, Djalovski A, Kraus L, Louzoun Y, Feldman R. Brain-to-Brain Synchrony during Naturalistic Social Interactions. Sci Rep. 2017 Dec 6;7(1):17060. doi: 10.1038/s41598-017-17339-5.
- Background: PubMed 20808907Dumas G, Nadel J, Soussignan R, Martinerie J, Garnero L. Inter-brain synchronization during social interaction. PLoS One. 2010 Aug 17;5(8):e12166. doi: 10.1371/journal.pone.0012166.
- Background: PubMed 32180710Czeszumski A, Eustergerling S, Lang A, Menrath D, Gerstenberger M, Schuberth S, Schreiber F, Rendon ZZ, Konig P. Hyperscanning: A Valid Method to Study Neural Inter-brain Underpinnings of Social Interaction. Front Hum Neurosci. 2020 Feb 28;14:39. doi: 10.3389/fnhum.2020.00039. eCollection 2020.
- Background: PubMed 38866073Carollo A, Esposito G. Hyperscanning literature after two decades of neuroscientific research: A scientometric review. Neuroscience. 2024 Jul 23;551:345-354. doi: 10.1016/j.neuroscience.2024.05.045. Epub 2024 Jun 10.
- Background: PubMed 34558155Hirano Y, Uhlhaas PJ. Current findings and perspectives on aberrant neural oscillations in schizophrenia. Psychiatry Clin Neurosci. 2021 Dec;75(12):358-368. doi: 10.1111/pcn.13300. Epub 2021 Oct 29.
- Background: PubMed 23999082Geng JJ, Vossel S. Re-evaluating the role of TPJ in attentional control: contextual updating? Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2608-20. doi: 10.1016/j.neubiorev.2013.08.010. Epub 2013 Aug 30.
- Background: PubMed 38770754daSilva EB, Wood A. How and Why People Synchronize: An Integrated Perspective. Pers Soc Psychol Rev. 2025 May;29(2):159-187. doi: 10.1177/10888683241252036. Epub 2024 May 21.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We propose to use a clinical linguistic archiving system called the TalkBank (https://www.talkbank.org/) for data sharing purposes. TalkBank registry/database is located at Carnegie Mellon University, Pittsburgh, Pennsylvania-USA. Several filters are used to de-identify the recorded speech data before storage in the databank. Firstly, the Discourse protocol explicitly avoids using proper nouns and names/addresses. Second, the transcribed data is checked, and any proper names are replaced by common names (e.g., 'McGill' will be changed to 'University') or bleeped out (for audio data). If requested, we will play back the recorded responses to check if the participant is comfortable with the degree of anonymity. Identifying demodemographics will not be stored alongside the speech data to reduce triangulation. Finally, sharing is controlled by password protection, and a re-review is done to remove identifying information before sharing is initiated.
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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.
Lena Palaniyappan, MD, PhD principal investigator
Douglas Mental Health University Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis and Schizophrenia Disorders, run by Douglas Mental Health University Institute at 1 site in Canada.
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 4 inclusion and 4 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 18 May 2025. 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 Canada. 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 Emmanuel Olarewaju, PhD Candidate (5147616131 ext. 2005, emmanuel.olarewaju@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-brain phase synchronization using Phase Locking Index via hyperscanning during communication (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06978803, which also lists 28 linked publications.
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 18 May 2025.