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Social Cognition in Severe Alcohol Use Disorder

Social Cognition in Severe Alcohol Use Disorder: Towards a Neuroscientific Model Linking Cognitive Processes, Neurostructural Correlates, and Social Functioning

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07464613
Acronym
COSMO
Enrollment
60
Registered
2026-03-11
Start date
2026-05-11
Completion date
2028-12-01
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Keywords

Alcohol use disorder, MRI exam, social cognition, social functioning, neuropsychology

Brief 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). 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 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. Study timeline Assessments will occur at multiple time points: 1. Clinical evaluation 2. Neuropsychological assessment 3. MRI acquisition 4. EMA and passive smartphone data collection (14 days) 5. 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.

Interventions

BEHAVIORALAnalysis of social functioning and social cognition processes

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

Sponsors

CHU de Reims
Lead SponsorOTHER
Université de Reims Champagne-Ardenne
CollaboratorOTHER
EPSM de la Marne
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

participants are assigned to one of two or more groups in parallel for the duration of the study

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1. AUD patients Inclusion criteria: * 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

Exclusion criteria

* 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 * Contraindication to the use of MRI * Individuals particularly protected by the law * No smartphone with Apple or Android operating system 2. Healthy control participants: Inclusion criteria: * 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

Design outcomes

Primary

MeasureTime frameDescription
MRI exam: brain structuresDay 3Evaluated 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 recognitionDay 2Evaluated 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 mindDay 2Evaluated 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 dataDuring 14 daysDaily 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.)

Secondary

MeasureTime frameDescription
Executive functions: mental flexibility performances and processing speedDay 2Evaluated 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.)

Countries

France

Contacts

CONTACTFranca Schmid
franca.schmid1@univ-reims.fr03 26 61 19 30
CONTACTFarid Benzerouk
benzeroukf@epsm-marne.fr03 26 61 19 30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026