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临床试验/NCT04647422
NCT04647422
已完成
不适用

Investigation of Social Cognition and Executive Functions as Cognitive Vulnerability Markers for the Development and Maintenance of Alcohol Use Disorders - a Transverse Study Design

CHU de Reims1 个研究点 分布在 1 个国家目标入组 216 人2020年12月9日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Alcohol Use Disorder
发起方
CHU de Reims
入组人数
216
试验地点
1
主要终点
Social cognition: facial emotion recognition
状态
已完成
最后更新
3个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2020年12月9日
结束日期
2024年12月5日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
CHU de Reims
责任方
Sponsor

入排标准

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Social cognition: facial emotion recognition

时间窗: Day 0

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.)

Executive functions: inhibition of an ongoing motor response

时间窗: Day 0

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.)

Executive functions: mental flexibility performances and processing speed

时间窗: Day 0

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

时间窗: Day 0

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

时间窗: Day 0

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)

Social cognition: cognitive and affective theory of mind

时间窗: Day 0

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.)

次要结局

  • fMRI behavioral responses during a cognitive and affective theory of mind task(Day 0)
  • Duration of ocular fixations(Day 0)
  • Number of ocular saccades(Day 0)
  • Localization of the first ocular fixation(Day 0)
  • fMRI activations during a cognitive and affective theory of mind task(Day 0)

研究点 (1)

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