Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals with Alcohol Use Disorder (TRAC)

Low utilization of addiction treatment is a public health problem. A number of factors are associated with lack of treatment, including public stigma, self-stigma, and beliefs that people with addiction should solve their problem on their own. Stigma exposes individuals to social rejection, which may sustain the anxiety of rejection, and exacerbate certain mental disorders such as addictions. Social cognition disorders have been shown to be present in addictions, but one dimension of social cognition, emotional sensitivity to rejection (ESR), has been less studied. Rejection sensitivity could be considered a critical element in access to care and the relapse process.

The study authors hypothesize a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients. Specifically, they hypothesize that participants with a greater change in negative experience after a rejection situation on a Cyberball task, as measured by the negative subscale of the Positive and Negative Affect Schedule (PANAS), will have a higher percentage of days with heavy drinking during the last four weeks to three months of follow-up.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol-Induced Disorders; Ostracism
• Intervention / Treatment: Other: Cyberball task

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient admitted to the Grau-du-Roi Follow-up and Rehabilitation Care Service.
• Patient abstinent from alcohol for at least 10 days.
• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

• Other mental health disorder: bipolar disorder, schizophrenia, severe acute depression, borderline personality.
• Severe substance use disorder (SUD).
• Current suicidal ideation as judged by clinician.
• Patient unable to give consent.
• Pregnant or breastfeeding patient.
• The subject is participating in a Category 1 interventional study, or is in a period of exclusion determined by a previous study
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAtients withdrawn from alcohol	Other: Cyberball task; The game consists of ball throws between animated characters lasting about 50 throws. In the rejection condition, after 2 or 3 throws, the participant no longer receives the ball (no more passes). In the control conditions ("all included"), the participant receives the ball as often as the others.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Role of emotional reaction to social rejection (Cyberball game)	Positive And Negative Affect Schedule (PANAS) (negative affect score). Scores can range from 10 to 50 for positive and negative emotions, with lower scores representing lower levels of positive/negative emotional engagement and higher scores representing higher levels of positive/negative emotional engagement.	Day 0; before Cyberball task
Role of emotional reaction to social rejection (Cyberball game)	Positive And Negative Affect Schedule (PANAS) (negative affect score). Scores can range from 10 to 50 for positive and negative emotions, with lower scores representing lower levels of positive/negative emotional engagement and higher scores representing higher levels of positive/negative emotional engagement.	Day 0; after Cyberball task
Percentage of heavy drinking days in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 3
Correlation between percentage of heavy drinking days and the difference between the PANAS negative subscale scores at baseline and after the Cyberball task in the exclusion phase (=rejection situation).	Multiple linear regression	Day 0; before Cyberball task
Correlation between percentage of heavy drinking days and the difference between the PANAS negative subscale scores at baseline and after the Cyberball task in the exclusion phase (=rejection situation).	Multiple linear regression	Day 0; after Cyberball task
Correlation between percentage of heavy drinking days and the difference between the PANAS negative subscale scores at baseline and after the Cyberball task in the exclusion phase (=rejection situation).	Multiple linear regression	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of heavy drinking days in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 3
Adverse childhood events	Adverse childhood events (ACE) score	Day 0
Patient level of distress due to rejection	Need Threat Scale (NTS) score	Day 0; after Cyberball task
Patient self-stigma due to alcohol dependence	Self-stigma in Alcohol Dependence (SSAD) scale score	Day 0
Patient depression	Patient Health Questionnaire (PHQ-9) score	Day 0
Patient depression	Patient Health Questionnaire (PHQ-9) score	Month 3
Patient depression	Patient Health Questionnaire (PHQ-9) score	Month 6
Patient depression	Patient Health Questionnaire (PHQ-9) score	Month 12
Patient anxiety	Generalized Anxiety Disorder-7 (GAD-7) score	Day 0
Patient anxiety	Generalized Anxiety Disorder-7 (GAD-7) score	Month 3
Patient anxiety	Generalized Anxiety Disorder-7 (GAD-7) score	Month 6
Patient anxiety	Generalized Anxiety Disorder-7 (GAD-7) score	Month 12
Number of days of alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 3
Number of days of alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 6
Number of days of alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 12
Number of days of heavy alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 3
Number of days of heavy alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 6
Number of days of heavy alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 12
Percentage of heavy drinking days in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 6
Percentage of heavy drinking days in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 12
Lifetime history of suicide attempts	Number	Day 0
Current treatments	List of current treatments taken from patient medical file	Day 0
Patient dispositional (i.e. trait) empathy	Interpersonal reactivity index (IRI) score	Day 0
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Positive And Negative Affect Schedule (PANAS) after the rejection situation.		Day 0; before Cyberball task
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Positive And Negative Affect Schedule (PANAS) after the rejection situation.		Day 0; after Cyberball task
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.		Day 0; before Cyberball task
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.		Day 0; after Cyberball task

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Amandine Luquiens, CHU de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): January 15, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Rejection; Adverse childhood experiences
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Alcoholism; Alcohol Drinking; Alcohol-Induced Disorders
• Other Study ID Numbers: NIMAO/2022-2/AL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No