Alcohol Use DisorderCOSMONCT07464613
Social Cognition in Severe Alcohol Use Disorder
A study testing Analysis of social functioning and social cognition processes in people with Alcohol Use Disorder, run by CHU de Reims at 1 site in France.
Trial summary
With 41,000 deaths per year, alcohol consumption is the second leading cause of preventable mortality in France. Nearly 3.4% of adults engage in excessive and chronic alcohol use, meeting criteria for Severe Alcohol Use Disorder (SAUD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Analysis of social functioning and social cognition processes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2026to Dec 2028
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18 and 65 years old, men or women, right-handed, following AUD treatment as inpatients or outpatients and currently abstinent
- Having a diagnosis of severe alcohol use disorder according to DSM-5 criteria
- Native French speakers
- Patients enrolled in the national healthcare insurance program
- Patients consenting to participate in the study
- Participants between 18 and 65 years old, men or women, right-handed
Show all 9Show fewer
- Native French speakers
- Participants enrolled in the national healthcare insurance program
- Participants consenting to participate in the study
Who cannot join
- A diagnosis of schizophrenia, of any other chronic psychotic state, or of bipolar disorder according to DSM-5 criteria
- The presence of a current depressive episode as defined by DSM-5 criteria
- The presence of another moderate or severe substance use disorder according to DSM-5 criteria, except for tobacco and cannabis if alcohol is the primary substance consumed and the criteria for cannabis dependence are not met
- The presence of a neurodevelopmental disorder
- The presence of any clinically significant or unstable pathology: organic pathology affecting the central nervous system or disease likely to interfere with assessments, including the neurological complications of alcoholism
- Having any uncorrected auditory or visual deficits
Show all 20Show fewer
- Contraindication to the use of MRI
- Individuals particularly protected by the law
- No smartphone with Apple or Android operating system
- Healthy control participants:
- A diagnosis of schizophrenia, of any other chronic psychotic state, or of bipolar disorder according to DSM-5 criteria
- The presence of a current depressive episode as defined by DSM-5 criteria
- The presence of substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence
- Having any first-degree relative with alcohol use disorder according to DSM-5 diagnostic criteria
- The presence of a neurodevelopmental disorder
- The presence of any clinically significant or unstable pathology: organic pathology affecting the central nervous system
- Having any uncorrected auditory or visual deficits
- Contraindication to the use of MRI
- Individuals particularly protected by the law
- No smartphone with Apple or Android operating system
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
Chu Reims
Reims, Reims, 51092
Marie MULLER, 326832763 ext. 33, recherche.clinique@chu-reims.fr
About this study
Official title: Social Cognition in Severe Alcohol Use Disorder: Towards a Neuroscientific Model Linking Cognitive Processes, Neurostructural Correlates, and Social Functioning
With 41,000 deaths per year, alcohol consumption is the second leading cause of preventable mortality in France. Nearly 3.4% of adults engage in excessive and chronic alcohol use, meeting criteria for Severe Alcohol Use Disorder (SAUD).
SAUD is associated with cerebral and cognitive alterations, including deficits in social cognition. These deficits manifest as difficulties in perceiving and interpreting social cues during interactions and encompass, in particular, the recognition of emotional facial expressions and the accurate attribution of others' beliefs, emotions, and intentions (i.e., theory of mind). Such alterations contribute to interpersonal difficulties and psychological distress and are recognized as risk factors for the development and maintenance of SAUD.
Read more
To date, social cognition has primarily been explored through behavioral tests, providing a description of deficits without examining their neuro-structural correlates. Moreover, no neuroscientific study has investigated the impact of sex and concomitant tobacco use on social cognition and associated brain structures in SAUD, although these factors are known to influence both social cognitive abilities and cerebral organization in this disorder. Finally, the everyday consequences of these alterations on social functioning and the trajectory of alcohol consumption remain poorly explored.
In this context, the present project aims, first, to explore the neuro-structural correlates of social cognition deficits in SAUD using psychometric assessments (i.e., emotion recognition, theory of mind) combined with magnetic resonance imaging (MRI). The impact of sex and tobacco use will be accounted for by including these variables as covariates in statistical analyses. Second, the project seeks to assess the daily-life impact of social cognition deficits on the social functioning of individuals with SAUD (i.e., quantity and quality of social interactions) and on the evolution of alcohol use behaviors six months after hospitalization (i.e., risk of relapse).
The study will include two participant groups: individuals with SAUD and age-, sex-, and education-matched control participants.
The expected results will refine our understanding of social cognition alterations in SAUD, thereby contributing to the improvement of current neuroscientific models. These advances will pave the way for the identification of potential targets for prevention programs and therapeutic interventions.
Read the detailed description
Nearly 3.4% of adults engage in excessive and chronic alcohol use, meeting criteria for Severe Alcohol Use Disorder (SAUD). SAUD is associated with cerebral and cognitive alterations, including deficits in social cognition. These deficits manifest as difficulties in perceiving and interpreting social cues during interactions and encompass, in particular, the recognition of emotional facial expressions and the accurate attribution of others' beliefs, emotions, and intentions (i.e., theory of mind). Such alterations contribute to interpersonal difficulties and psychological distress and are recognized as risk factors for the development and maintenance of SAUD.
To date, social cognition has primarily been explored through behavioral tests, providing a description of deficits without examining their neuro-structural correlates. Moreover, no neuroscientific study has investigated the impact of sex and concomitant tobacco use on social cognition and associated brain structures in SAUD, although these factors are known to influence both social cognitive abilities and brain organization in this disorder. Finally, the everyday consequences of these alterations on social functioning and the trajectory of alcohol consumption remain poorly explored.
In this context, the present project aims, first, to explore the neuro-structural correlates of social cognition deficits in SAUD using psychometric assessments (i.e., emotion recognition, theory of mind) combined with magnetic resonance imaging (MRI). The impact of sex and tobacco use will be accounted for by including these variables as covariates in statistical analyses. Second, the project seeks to assess the daily-life impact of social cognition deficits on the social functioning of individuals with SAUD (i.e., quantity and quality of social interactions) and on the evolution of alcohol use behaviors six months after hospitalization (i.e., risk of relapse).
The study will include two participant groups: individuals with SAUD and age-, sex-, and education-matched control participants. The expected results will refine our understanding of social cognition alterations in SAUD, thereby contributing to the improvement of current neuroscientific models. These advances will pave the way for the identification of potential targets for prevention programs and therapeutic interventions.
Detailed Description
- State of the Art Severe Alcohol Use Disorder (SAUD) is associated with structural and functional brain alterations as well as cognitive impairments affecting memory and executive functions. Recent research also highlights deficits in social cognition, including emotion recognition and theory of mind. However, the neural correlates of these deficits remain poorly understood. Most neuroimaging studies in SAUD have focused on functional MRI tasks involving implicit emotional processing, whereas clinical neuropsychology typically relies on explicit behavioral assessments. Consequently, the structural brain correlates (gray and white matter) of social cognition deficits in SAUD remain largely unexplored. Social cognition impairments may contribute to difficulties in daily social functioning and could increase relapse risk. Ecological Momentary Assessment (EMA), combined with passive smartphone data, enables real-time assessment of social interactions in naturalistic settings and may provide a more accurate measure of daily social functioning than retrospective reports.
- Aims of this protocol Primary Objective:
- To investigate structural brain correlates (gray matter and white matter) of social cognition deficits (emotion recognition and theory of mind) in patients with SAUD. Secondary Objectives:
- To examine the influence of sex and tobacco use on cognitive and brain alterations related to social cognition
- To assess the relationship between social cognition deficits and daily social functioning using EMA and passive smartphone data
- To evaluate whether cognitive and brain alterations in social cognition predict relapse risk six months after detoxification.
- Hypotheses Social Cognition and Brain Alterations H1a: SAUD patients will show reduced gray matter volume and white matter integrity in brain regions involved in socio-emotional processing. H1b: Structural alterations will be associated with performance on social cognition tasks. H1c: Sex and tobacco use may modulate these associations. Social Cognition and Daily Functioning H2: Cognitive and brain deficits will predict poorer daily social functioning, assessed through self-reported interactions and passive smartphone data. Social Cognition and Relapse H3: Cognitive and brain deficits will predict relapse risk (alcohol consumption, craving, anxiety, depression) six months after detoxification.
- Recruitment of participants Two groups will be recruited: SAUD patients (n = 30): Individuals hospitalized for alcohol withdrawal, abstinent for at least two weeks, without other substance use disorders (except tobacco use disorder and occasional cannabis consumption) or severe psychiatric/neurological illness. Healthy controls (n = 30): Individuals without substance use disorders or severe psychiatric/neurological illness, matched for age and socioeconomic status.
- Levels of investigation Clinical Assessment: A physician specialized in addiction medicine will collect sociodemographic and clinical data, including alcohol and drug use, psychiatric symptoms, impulsivity, and socio-emotional functioning (e.g., empathy, alexithymia, emotion regulation). Neuropsychological Assessment: Participants will complete tests assessing general cognitive functioning, executive functions (inhibition, mental flexibility), and social cognition (facial emotion recognition and theory of mind). MRI: MRI acquisition will include structural T1-weighted imaging, diffusion tensor imaging (DTI), and functional MRI during the viewing of two short movie clips. Ecological Momentary Assessment (EMA): For 14 days following the MRI session, participants will complete a daily smartphone questionnaire assessing social interactions. Passive smartphone data (e.g., call frequency, time on communication apps, step count) will also be collected to estimate social activity.
- Study timeline
Assessments will occur at multiple time points:
- Clinical evaluation
- Neuropsychological assessment
- MRI acquisition
- EMA and passive smartphone data collection (14 days)
- Six-month follow-up assessing relapse outcomes in SAUD patients 7/ Statistical analyses Group differences will be tested using mean comparisons, ANOVA, and generalized linear models. Associations between neuropsychological performance and neuroimaging measures will be examined using correlation analyses and regression models.
Structural MRI analyses will assess gray matter volume, cortical thickness, and cortical surface area across the whole brain and within social cognition-related regions of interest. White matter integrity will be evaluated using diffusion measures (fractional anisotropy, mean diffusivity) and tractography.
Regression analyses will identify predictors of social cognition deficits, daily social functioning (EMA and passive data), and relapse outcomes.
- Conditions
- Alcohol Use Disorder
- Being tested
- Analysis of social functioning and social cognition processes
- Keywords
- Alcohol use disorder, MRI exam, social cognition, social functioning, neuropsychology
- Medical subject headings
- Alcoholism, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of social functioning and social cognition processesBehavioural
Investigation of functioning and social cognition processes using a comprehensive, neuropsychological assessment and MRI exam.
- Evaluation of addictive, psychiatric and neurological comorbidities.
- Neuropsychological assessment establishing the participants cognitive profiles of executive functions and of social cognition
- Collection of smartphone-based data that is descriptive of participants daily social functioning
- MRI exam identifying participants neuroanatomical and neurofunctional correlates of social cognition processes
| Study group | Role | What they receive |
|---|---|---|
| AUD patients | Experimental | Alcohol Use Disorder patients Receives: Behavioral: Analysis of social functioning and social cognition processes |
| AUD controls | Experimental | Healthy control participants matched to group 1 Receives: Behavioral: Analysis of social functioning and social cognition processes |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI exam: brain structures
Evaluated through a high-resolution 3D anatomical image, diffusion tensor images and a functional MRI sequence (passive visualization of two short movie clips). Examination of brain structures to identify the neuroanatomical and neurofunctional correlates of social cognition processes in the Alcohol Use Disorder patients.
Measured: Day 3
Social cognition: facial emotion recognition
Evaluated through a test of facial emotion recognition (TREF). The participant is shown 54 photographs depicting 6 different emotions of variable intensity (joy, anger, sadness, disgust, contempt, fear) for which he must choose the corresponding emotion label. Are measured participant's response times, the number of correct responses (score out of 54) and type of errors.
(Gaudelus, B., Virgile, J., Peyroux, E., b, Leleu, A., c, Baudouin J.Y., Franck N. (2015). Mesure du déficit de reconnaissance des émotions faciales dans la schizophrénie. Étude préliminaire du test de reconnaissance des émotions faciales (TREF). L'Encéphale 41(3), 251-259.)
Measured: Day 2
Social cognition: cognitive and affective theory of mind
Evaluated through The Movie of Assessment for Social Cognition (MASC). The participant is shown a movie of approximately 15 minutes displaying people interacting with each other. From time to time, the movie is stopped, and the participant must answer different questions relating to the thoughts and feelings of the characters. Are measured the number of correct responses out of 45.
(Dziobek I, Fleck S, Kalbe E, Rogers K, Hassenstab J, Brand M, Kessler J, Woike JK, Wolf OT, Convit A.J (2006). Journal of Autism and Developmental Disorders 36(5), 623-36.)
Measured: Day 2
Everyday social functioning: EMA and passive smartphone data
Daily social functioning will be assessed using Ecological Momentary Assessment (EMA) via the Behapp application (University of Groningen). Behapp will send a daily questionnaire to the participant's smartphone at the end of the day for 14 consecutive days, assessing the quantity and quality of social interactions through 20 items. The Behapp app collects passive mobile data providing a more comprehensive evaluation of social functioning : Number and duration of incoming and outgoing phone calls (only metadata are collected), time spent on social media applications (only aggregated data are collected), number of unique locations visited (without GPS coordinates or exact addresses), screen states and movement patterns (e.g., step counts).
(Jagesar, R. R., at al (2021). Digital phenotyping and the COVID-19 pandemic: capturing behavioral change in patients with psychiatric disorders. European Neuropsychopharmacology, 42, 115-120.)
Measured: During 14 days
Secondary outcomes (1)
Executive functions: mental flexibility performances and processing speed
Evaluated through the Trail Making Test (TMT parts A and B). In part A the participant must connect as quick as possible all the numbers on a sheet of paper in ascending order (1-25). In part B the participant is asked to connect all the numbers in ascending order (1-13) and all the letters according to their alphabetical order (A-L) whilst alternating between numbers and letters and without lifting the pencil. For both parts is reported the time necessary for task completion in seconds.
(Reitan RM, Wolfson D (1985) The Halstead-Reitan Neuropsychological Test Battery. Neuropsychology Press, Tucson, AZ.)
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start11 May 2026
- Primary completion11 Nov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Reims Champagne-Ardenne, Public Mental Health Institution of the Marne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464613
- Sponsor's protocol ID
- PO25120*
- Acronym
- COSMO
- Status last verified
- May 2026
- First submitted
- 27 Feb 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition in Severe Alcohol Use Disorder: Towards a Neuroscientific Model Linking Cognitive Processes, Neurostructural Correlates, and Social Functioning
- ClinicalTrials.gov ID
- NCT07464613
- Acronym / sponsor ID
- COSMO / PO25120*
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol use disorder, MRI exam, social cognition, social functioning, neuropsychology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Collaborators
- Université de Reims Champagne-Ardenne, Public Mental Health Institution of the Marne
- Study start
- 11 May 2026 (actual)
- Primary completion
- 11 Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Mar 2026 (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.
With 41,000 deaths per year, alcohol consumption is the second leading cause of preventable mortality in France. Nearly 3.4% of adults engage in excessive and chronic alcohol use, meeting criteria for Severe Alcohol Use Disorder (SAUD).
SAUD is associated with cerebral and cognitive alterations, including deficits in social cognition. These deficits manifest as difficulties in perceiving and interpreting social cues during interactions and encompass, in particular, the recognition of emotional facial expressions and the accurate attribution of others' beliefs, emotions, and intentions (i.e., theory of mind). Such alterations contribute to interpersonal difficulties and psychological distress and are recognized as risk factors for the development and maintenance of SAUD.
To date, social cognition has primarily been explored through behavioral tests, providing a description of deficits without examining their neuro-structural correlates. Moreover, no neuroscientific study has investigated the impact of sex and concomitant tobacco use on social cognition and associated brain structures in SAUD, although these factors are known to influence both social cognitive abilities and cerebral organization in this disorder. Finally, the everyday consequences of these alterations on social functioning and the trajectory of alcohol consumption remain poorly explored.
In this context, the present project aims, first, to explore the neuro-structural correlates of social cognition deficits in SAUD using psychometric assessments (i.e., emotion recognition, theory of mind) combined with magnetic resonance imaging (MRI). The impact of sex and tobacco use will be accounted for by including these variables as covariates in statistical analyses. Second, the project seeks to assess the daily-life impact of social cognition deficits on the social functioning of individuals with SAUD (i.e., quantity and quality of social interactions) and on the evolution of alcohol use behaviors six months after hospitalization (i.e., risk of relapse).
The study will include two participant groups: individuals with SAUD and age-, sex-, and education-matched control participants.
The expected results will refine our understanding of social cognition alterations in SAUD, thereby contributing to the improvement of current neuroscientific models. These advances will pave the way for the identification of potential targets for prevention programs and therapeutic interventions.
Detailed description
Nearly 3.4% of adults engage in excessive and chronic alcohol use, meeting criteria for Severe Alcohol Use Disorder (SAUD). SAUD is associated with cerebral and cognitive alterations, including deficits in social cognition. These deficits manifest as difficulties in perceiving and interpreting social cues during interactions and encompass, in particular, the recognition of emotional facial expressions and the accurate attribution of others' beliefs, emotions, and intentions (i.e., theory of mind). Such alterations contribute to interpersonal difficulties and psychological distress and are recognized as risk factors for the development and maintenance of SAUD.
To date, social cognition has primarily been explored through behavioral tests, providing a description of deficits without examining their neuro-structural correlates. Moreover, no neuroscientific study has investigated the impact of sex and concomitant tobacco use on social cognition and associated brain structures in SAUD, although these factors are known to influence both social cognitive abilities and brain organization in this disorder. Finally, the everyday consequences of these alterations on social functioning and the trajectory of alcohol consumption remain poorly explored.
In this context, the present project aims, first, to explore the neuro-structural correlates of social cognition deficits in SAUD using psychometric assessments (i.e., emotion recognition, theory of mind) combined with magnetic resonance imaging (MRI). The impact of sex and tobacco use will be accounted for by including these variables as covariates in statistical analyses. Second, the project seeks to assess the daily-life impact of social cognition deficits on the social functioning of individuals with SAUD (i.e., quantity and quality of social interactions) and on the evolution of alcohol use behaviors six months after hospitalization (i.e., risk of relapse).
The study will include two participant groups: individuals with SAUD and age-, sex-, and education-matched control participants. The expected results will refine our understanding of social cognition alterations in SAUD, thereby contributing to the improvement of current neuroscientific models. These advances will pave the way for the identification of potential targets for prevention programs and therapeutic interventions.
Detailed Description
- State of the Art Severe Alcohol Use Disorder (SAUD) is associated with structural and functional brain alterations as well as cognitive impairments affecting memory and executive functions. Recent research also highlights deficits in social cognition, including emotion recognition and theory of mind. However, the neural correlates of these deficits remain poorly understood. Most neuroimaging studies in SAUD have focused on functional MRI tasks involving implicit emotional processing, whereas clinical neuropsychology typically relies on explicit behavioral assessments. Consequently, the structural brain correlates (gray and white matter) of social cognition deficits in SAUD remain largely unexplored. Social cognition impairments may contribute to difficulties in daily social functioning and could increase relapse risk. Ecological Momentary Assessment (EMA), combined with passive smartphone data, enables real-time assessment of social interactions in naturalistic settings and may provide a more accurate measure of daily social functioning than retrospective reports.
- Aims of this protocol Primary Objective:
- To investigate structural brain correlates (gray matter and white matter) of social cognition deficits (emotion recognition and theory of mind) in patients with SAUD. Secondary Objectives:
- To examine the influence of sex and tobacco use on cognitive and brain alterations related to social cognition
- To assess the relationship between social cognition deficits and daily social functioning using EMA and passive smartphone data
- To evaluate whether cognitive and brain alterations in social cognition predict relapse risk six months after detoxification.
- Hypotheses Social Cognition and Brain Alterations H1a: SAUD patients will show reduced gray matter volume and white matter integrity in brain regions involved in socio-emotional processing. H1b: Structural alterations will be associated with performance on social cognition tasks. H1c: Sex and tobacco use may modulate these associations. Social Cognition and Daily Functioning H2: Cognitive and brain deficits will predict poorer daily social functioning, assessed through self-reported interactions and passive smartphone data. Social Cognition and Relapse H3: Cognitive and brain deficits will predict relapse risk (alcohol consumption, craving, anxiety, depression) six months after detoxification.
- Recruitment of participants Two groups will be recruited: SAUD patients (n = 30): Individuals hospitalized for alcohol withdrawal, abstinent for at least two weeks, without other substance use disorders (except tobacco use disorder and occasional cannabis consumption) or severe psychiatric/neurological illness. Healthy controls (n = 30): Individuals without substance use disorders or severe psychiatric/neurological illness, matched for age and socioeconomic status.
- Levels of investigation Clinical Assessment: A physician specialized in addiction medicine will collect sociodemographic and clinical data, including alcohol and drug use, psychiatric symptoms, impulsivity, and socio-emotional functioning (e.g., empathy, alexithymia, emotion regulation). Neuropsychological Assessment: Participants will complete tests assessing general cognitive functioning, executive functions (inhibition, mental flexibility), and social cognition (facial emotion recognition and theory of mind). MRI: MRI acquisition will include structural T1-weighted imaging, diffusion tensor imaging (DTI), and functional MRI during the viewing of two short movie clips. Ecological Momentary Assessment (EMA): For 14 days following the MRI session, participants will complete a daily smartphone questionnaire assessing social interactions. Passive smartphone data (e.g., call frequency, time on communication apps, step count) will also be collected to estimate social activity.
- Study timeline
Assessments will occur at multiple time points:
- Clinical evaluation
- Neuropsychological assessment
- MRI acquisition
- EMA and passive smartphone data collection (14 days)
- Six-month follow-up assessing relapse outcomes in SAUD patients 7/ Statistical analyses Group differences will be tested using mean comparisons, ANOVA, and generalized linear models. Associations between neuropsychological performance and neuroimaging measures will be examined using correlation analyses and regression models.
Structural MRI analyses will assess gray matter volume, cortical thickness, and cortical surface area across the whole brain and within social cognition-related regions of interest. White matter integrity will be evaluated using diffusion measures (fractional anisotropy, mean diffusivity) and tractography.
Regression analyses will identify predictors of social cognition deficits, daily social functioning (EMA and passive data), and relapse outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| AUD patients | Experimental | Behavioral: Analysis of social functioning and social cognition processesAlcohol Use Disorder patients |
| AUD controls | Experimental | Behavioral: Analysis of social functioning and social cognition processesHealthy control participants matched to group 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants between 18 and 65 years old, men or women, right-handed
- Native French speakers
- Participants enrolled in the national healthcare insurance program
- Participants consenting to participate in the study
Key exclusion criteria (20 listed)
- Healthy control participants:
- A diagnosis of schizophrenia, of any other chronic psychotic state, or of bipolar disorder according to DSM-5 criteria
- The presence of a current depressive episode as defined by DSM-5 criteria
- The presence of substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence
- Having any first-degree relative with alcohol use disorder according to DSM-5 diagnostic criteria
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 |
|---|---|---|
| Analysis of social functioning and social cognition processesInvestigation of functioning and social cognition processes using a comprehensive, neuropsychological assessment and MRI exam. * Evaluation of addictive, psychiatric and neurological comorbidities. * Neuropsychological assessment establishing the participants cognitive profiles of executive functions and of social cognition * Collection of smartphone-based data that is descriptive of participants daily social functioning * MRI exam identifying participants neuroanatomical and neurofunctional correlates of social cognition processes | Behavioural | AUD controls, AUD patients |
Primary outcome
MRI exam: brain structures
Time frame: Day 3
Evaluated through a high-resolution 3D anatomical image, diffusion tensor images and a functional MRI sequence (passive visualization of two short movie clips). Examination of brain structures to identify the neuroanatomical and neurofunctional correlates of social cognition processes in the Alcohol Use Disorder patients.
Social cognition: facial emotion recognition
Time frame: Day 2
Evaluated through a test of facial emotion recognition (TREF). The participant is shown 54 photographs depicting 6 different emotions of variable intensity (joy, anger, sadness, disgust, contempt, fear) for which he must choose the corresponding emotion label. Are measured participant's response times, the number of correct responses (score out of 54) and type of errors. (Gaudelus, B., Virgile, J., Peyroux, E., b, Leleu, A., c, Baudouin J.Y., Franck N. (2015). Mesure du déficit de reconnaissance des émotions faciales dans la schizophrénie. Étude préliminaire du test de reconnaissance des émotions faciales (TREF). L'Encéphale 41(3), 251-259.)
Social cognition: cognitive and affective theory of mind
Time frame: Day 2
Evaluated through The Movie of Assessment for Social Cognition (MASC). The participant is shown a movie of approximately 15 minutes displaying people interacting with each other. From time to time, the movie is stopped, and the participant must answer different questions relating to the thoughts and feelings of the characters. Are measured the number of correct responses out of 45. (Dziobek I, Fleck S, Kalbe E, Rogers K, Hassenstab J, Brand M, Kessler J, Woike JK, Wolf OT, Convit A.J (2006). Journal of Autism and Developmental Disorders 36(5), 623-36.)
Everyday social functioning: EMA and passive smartphone data
Time frame: During 14 days
Daily social functioning will be assessed using Ecological Momentary Assessment (EMA) via the Behapp application (University of Groningen). Behapp will send a daily questionnaire to the participant's smartphone at the end of the day for 14 consecutive days, assessing the quantity and quality of social interactions through 20 items. The Behapp app collects passive mobile data providing a more comprehensive evaluation of social functioning : Number and duration of incoming and outgoing phone calls (only metadata are collected), time spent on social media applications (only aggregated data are collected), number of unique locations visited (without GPS coordinates or exact addresses), screen states and movement patterns (e.g., step counts). (Jagesar, R. R., at al (2021). Digital phenotyping and the COVID-19 pandemic: capturing behavioral change in patients with psychiatric disorders. European Neuropsychopharmacology, 42, 115-120.)
1 secondary outcome
Executive functions: mental flexibility performances and processing speed
Time frame: Day 2
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 26 May 2026.
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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 Analysis of social functioning and social cognition processes in people with Alcohol Use Disorder, run by CHU de Reims 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 9 inclusion and 20 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 26 May 2026. 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 Franca Schmid (03 26 61 19 30 ext. 0033, franca.schmid1@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI exam: brain structures (time frame: Day 3). The study lists 4 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 26 May 2026.