Social Cognition in Severe Alcohol Use Disorder
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCHU de Reims
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
AUD patients
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Analysis of social functioning and social cognition processes
BehavioralInvestigation 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: AUD patientsExperimental treatment 1 intervention
Group B: AUD controlsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 32
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.)
Time frame
Day 23
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.)
Time frame
Day 24
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.)
Time frame
During 14 daysSecondary 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.)
Time frame
Day 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
CHU de Reims
Lead sponsor
Université de Reims Champagne-Ardenne
Collaborator
EPSM de la Marne
Collaborator
Source ClinicalTrials.gov