Back to resultsSocial Cognition and Executive Functions in Alcohol Use Disorders - Transverse Study (COSEFEX-T)
Primary Purpose
Alcohol Use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Analysis of executive functioning and of social cognition processes
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Use Disorder focused on measuring Alcohol use disorder, high-risk individuals, executive functions, social cognition, endophenotypes, neuropsychology
Eligibility Criteria
AUD patients
Inclusion criteria:
- Patients between 18 and 60 years old, men or women, following AUD treatment
- Having a diagnosis of alcohol use disorder according to DSM-5 criteria
- Patients withdrawn of alcohol for at least 15 days
- Patients being a native French speaker
- Patients enrolled in the national healthcare insurance program
- Patients consenting to participate to 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 substance use disorder during the six months preceding the study, except for tobacco dependence.
- The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
- The presence of any neurological disorder or any other disorder affecting the central nervous system including Korsakoff syndrome or Wernicke's encephalopathy
- Having any uncorrected auditory or visual deficits
First-degree relatives of AUD patients
Inclusion criteria:
- Participants between 18 and 60 years old, men or women
- Current and past absence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria
- Participants having at least one first-degree relative presenting an alcohol use disorder (father or sibling)
- Participants being a native French speaker
- Participants enrolled in the national healthcare insurance program
- Participants consenting to participate to the study
exclusion criteria:
- The presence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence
- 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 any alcohol use disorder in the participant's biological mother in order to exclude fetal alcohol spectrum disorders due to prenatal alcohol intoxication
- The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
- The presence of any neurological disorder or any other disorder affecting the central nervous system
- Participants having any uncorrected auditory or visual deficits
- Healthy control participants (the inclusion and non-inclusion criteria of investigation groups 2 and 4 are identical):
Inclusion criteria:
- Participants between 18 and 60 years old, men or women
- Current and past absence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria
- Participants being a native French speaker
- Participants enrolled in the national healthcare insurance program
- Participants consenting to participate to the study
exclusion criteria:
- The presence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence
- 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
- Having any first-degree relative with alcohol use disorder (parents, siblings, children) according to DSM-5 diagnostic criteria
- The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
- The presence of any neurological disorder or any other disorder affecting the central nervous system
- Participants having any uncorrected auditory or visual deficits
Sites / Locations
- Damien JOLLYRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
AUD patients
AUD controls
First-degree relatives
First-degree controls
Arm Description
Alcohol Use Disorder patients
Healthy control participants matched to group 1
Healthy first-degree relatives of AUD patients
Healthy control participants matched to group 3
Outcomes
Primary Outcome Measures
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.)
Executive functions: mental flexibility performances
Evaluated through the Plus-Minus test. In this test, the participant is presented with three lists of 30 two-digit numbers. At first, the participant is asked to add three to all the numbers of a first list (+3). He must then subtract three from all the numbers of a second list (-3) and finally he must alternate between addition and subtraction when presented with a third list (+3/-3). Are measured the completion times for the three lists and participant's error rate.
(Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD (2000) The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cognitive Psychology 41, 49-100.)
Executive functions: prepotent response inhibition
Evaluated through the Stroop test. The participant is shown three different slides with 100 items for 45s each. On the first slide are written color words (Color-word congruent condition) that the participant must read as quickly as possible. On the second slide are shown color patches (Color congruent condition) that the participants must name as quickly as possible. Finally, in the third condition, the participant is shown color words written in different colors and must try to name the color of the ink of the word without reading it (Interference condition). Are collected the completion times for the tree slides as well as self-corrected and uncorrected errors.
(Golden C.J (1976) Identification of brain disorders by the Stroop color and word test. Journal of Clinical Psychology 32, 654-658)
Executive functions: inhibition of an ongoing motor response
Evaluated through the Stop signal task. The participant is presented with a series of photographs showing human faces and is instructed to categorize the photographs according to gender (Go trials). From time to time a red circle appears around the face after a variable time interval and the participant must then withhold his response (Stop trials). Are measured the response time on Go trials, the number and type of errors and the Stop Signal Reaction Time (SSRT).
(Verbruggen F., & Logan G.D. (2008) Response inhibition in the stop-signal paradigm. Trends in cognitive sciences 12, 418-424.)
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.)
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.)
Secondary Outcome Measures
Duration of ocular fixations
The mean duration of fixations will be evaluated using eye tracking. The participant is shown photographs of primary emotions and during the presentation are recorded his eye movements.
Number of ocular saccades
The number of saccades will be evaluated using eye tracking. The participant is shown photographs of primary emotions and during the presentation are recorded his eye movements.
Localization of the first ocular fixation
The localization of the first fixation will be evaluated using eye tracking. The participant is shown photographs of primary emotions and during the presentation are recorded his eye movements.
fMRI behavioral responses during a cognitive and affective theory of mind task
During the task will be recorded the participant's behavioral performance (number of correct responses).
fMRI activations during a cognitive and affective theory of mind task
Brain regions significantly activated during the task will be recorded as shown by the variations in the BOLD signal (whole brain analysis).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04647422
Brief Title
Social Cognition and Executive Functions in Alcohol Use Disorders - Transverse Study
Acronym
COSEFEX-T
Official Title
Investigation of Social Cognition and Executive Functions as Cognitive Vulnerability Markers for the Development and Maintenance of Alcohol Use Disorders - a Transverse Study Design
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
May 9, 2024 (Anticipated)
Study Completion Date
May 9, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Over the past few years, researchers and clinicians have stressed the major role of executive and social cognition impairments in the development and the maintenance of Alcohol Use Disorders (AUD).
Executive functions are defined as functions for behavioral control that help us to adjust the investigator's behavior in a flexible way in non-familiar, non-routine situations. Executive functions encompass different cognitive processes, such as inhibition, mental flexibility, updating, planification, abstraction, rule deduction or organization. Studies comparing AUD patients to healthy controls have shown that AUD usually is associated with a large range of deficits. More recently studies have also emphasized a weakness of executive functioning among healthy participants with a positive family history of AUD.
Social cognition refers to all cognitive processes that enable us to communicate and to interact with social environment in an appropriate manner. Among the most common social cognition sub-components are theory of mind (defined as the capacity to understand other people's mental states as for instance beliefs and desires), empathy, and emotion recognition. Emotional and interpersonal difficulties have a high prevalence in AUD and chronic alcohol consumption is often linked to social conflicts, misunderstandings, a lack of social support and isolation. Indeed, AUD patients have difficulties in understanding their own mental states and emotions as well as those of their social environment.
Few studies have investigated the interdependency between these cognitive impairments in AUD while a better understanding of the link between executive functions and social cognition seems crucial in order to better characterize the nature of AUD patients' deficits and thus their caring.
Detailed Description
The aim of the study is to describe cognitive processes (theory of mind, empathy, and emotion recognition) and executive functions (inhibition, mental flexibility) in patients with AUD and first degree relatives of patients with an AUD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Alcohol use disorder, high-risk individuals, executive functions, social cognition, endophenotypes, neuropsychology
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AUD patients
Arm Type
Experimental
Arm Description
Alcohol Use Disorder patients
Arm Title
AUD controls
Arm Type
Experimental
Arm Description
Healthy control participants matched to group 1
Arm Title
First-degree relatives
Arm Type
Experimental
Arm Description
Healthy first-degree relatives of AUD patients
Arm Title
First-degree controls
Arm Type
Experimental
Arm Description
Healthy control participants matched to group 3
Intervention Type
Behavioral
Intervention Name(s)
Analysis of executive functioning and of social cognition processes
Intervention Description
Investigation of executive and social cognition processes using a comprehensive, neuropsychological assessment, An Eye tracking investigation and Task-based MRI exams.
Evaluation of addictive, psychiatric and neurological comorbidities.
Neuropsychological assessment establishing the participants' cognitive profiles of executive functions and of social cognition
An Eye tracking investigation aiming at a better understanding of participants' emotional processing
Task-based MRI exams identifying participants' neuroanatomical and neurofunctional correlates of executive functions and of social cognition processes
Primary Outcome Measure Information:
Title
Executive functions: mental flexibility performances and processing speed
Description
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 0
Title
Executive functions: mental flexibility performances
Description
Evaluated through the Plus-Minus test. In this test, the participant is presented with three lists of 30 two-digit numbers. At first, the participant is asked to add three to all the numbers of a first list (+3). He must then subtract three from all the numbers of a second list (-3) and finally he must alternate between addition and subtraction when presented with a third list (+3/-3). Are measured the completion times for the three lists and participant's error rate.
(Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD (2000) The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cognitive Psychology 41, 49-100.)
Time Frame
Day 0
Title
Executive functions: prepotent response inhibition
Description
Evaluated through the Stroop test. The participant is shown three different slides with 100 items for 45s each. On the first slide are written color words (Color-word congruent condition) that the participant must read as quickly as possible. On the second slide are shown color patches (Color congruent condition) that the participants must name as quickly as possible. Finally, in the third condition, the participant is shown color words written in different colors and must try to name the color of the ink of the word without reading it (Interference condition). Are collected the completion times for the tree slides as well as self-corrected and uncorrected errors.
(Golden C.J (1976) Identification of brain disorders by the Stroop color and word test. Journal of Clinical Psychology 32, 654-658)
Time Frame
Day 0
Title
Executive functions: inhibition of an ongoing motor response
Description
Evaluated through the Stop signal task. The participant is presented with a series of photographs showing human faces and is instructed to categorize the photographs according to gender (Go trials). From time to time a red circle appears around the face after a variable time interval and the participant must then withhold his response (Stop trials). Are measured the response time on Go trials, the number and type of errors and the Stop Signal Reaction Time (SSRT).
(Verbruggen F., & Logan G.D. (2008) Response inhibition in the stop-signal paradigm. Trends in cognitive sciences 12, 418-424.)
Time Frame
Day 0
Title
Social cognition: facial emotion recognition
Description
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 0
Title
Social cognition: cognitive and affective theory of mind
Description
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 0
Secondary Outcome Measure Information:
Title
Duration of ocular fixations
Description
The mean duration of fixations will be evaluated using eye tracking. The participant is shown photographs of primary emotions and during the presentation are recorded his eye movements.
Time Frame
Day 0
Title
Number of ocular saccades
Description
The number of saccades will be evaluated using eye tracking. The participant is shown photographs of primary emotions and during the presentation are recorded his eye movements.
Time Frame
Day 0
Title
Localization of the first ocular fixation
Description
The localization of the first fixation will be evaluated using eye tracking. The participant is shown photographs of primary emotions and during the presentation are recorded his eye movements.
Time Frame
Day 0
Title
fMRI behavioral responses during a cognitive and affective theory of mind task
Description
During the task will be recorded the participant's behavioral performance (number of correct responses).
Time Frame
Day 0
Title
fMRI activations during a cognitive and affective theory of mind task
Description
Brain regions significantly activated during the task will be recorded as shown by the variations in the BOLD signal (whole brain analysis).
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
AUD patients
Inclusion criteria:
Patients between 18 and 60 years old, men or women, following AUD treatment
Having a diagnosis of alcohol use disorder according to DSM-5 criteria
Patients withdrawn of alcohol for at least 15 days
Patients being a native French speaker
Patients enrolled in the national healthcare insurance program
Patients consenting to participate to 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 substance use disorder during the six months preceding the study, except for tobacco dependence.
The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
The presence of any neurological disorder or any other disorder affecting the central nervous system including Korsakoff syndrome or Wernicke's encephalopathy
Having any uncorrected auditory or visual deficits
First-degree relatives of AUD patients
Inclusion criteria:
Participants between 18 and 60 years old, men or women
Current and past absence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria
Participants having at least one first-degree relative presenting an alcohol use disorder (father or sibling)
Participants being a native French speaker
Participants enrolled in the national healthcare insurance program
Participants consenting to participate to the study
exclusion criteria:
The presence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence
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 any alcohol use disorder in the participant's biological mother in order to exclude fetal alcohol spectrum disorders due to prenatal alcohol intoxication
The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
The presence of any neurological disorder or any other disorder affecting the central nervous system
Participants having any uncorrected auditory or visual deficits
Healthy control participants (the inclusion and non-inclusion criteria of investigation groups 2 and 4 are identical):
Inclusion criteria:
Participants between 18 and 60 years old, men or women
Current and past absence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria
Participants being a native French speaker
Participants enrolled in the national healthcare insurance program
Participants consenting to participate to the study
exclusion criteria:
The presence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence
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
Having any first-degree relative with alcohol use disorder (parents, siblings, children) according to DSM-5 diagnostic criteria
The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
The presence of any neurological disorder or any other disorder affecting the central nervous system
Participants having any uncorrected auditory or visual deficits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabien GIERSKI
Phone
03 26 91 36 34
Email
fabien.gierski@univ-reims.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Franca SCHMID
Email
franca.schmid@etudiant.univ-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien GIERSKI
Phone
03 26 91 36 34
Email
fabien.gierski@univ-reims.fr
First Name & Middle Initial & Last Name & Degree
Franca SCHMID
Email
franca.schmid@etudiant.univ-reims.fr
12. IPD Sharing Statement
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Social Cognition and Executive Functions in Alcohol Use Disorders - Transverse Study
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