Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals with Alcohol Use Disorder

Not Applicable

Active, not recruiting

• Conditions: Alcohol-Induced Disorders; Ostracism
• Interventions: Other: Cyberball task

• Registration Number: NCT05787106
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients.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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-24
• Study First Posted: 2023-03-28
• Study Start: 2023-05-31
• Primary Completion: 2025-01-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAtients withdrawn from alcohol	Cyberball task	-

Primary Outcome Measures

Name	Time	Method
Role of emotional reaction to social rejection (Cyberball game)	Day 0; after Cyberball task	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.
Percentage of heavy drinking days in the past 4 weeks	Month 3	Timeline Follow Back (TLFB) interview
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).	Month 3	Multiple linear regression

Secondary Outcome Measures

Name	Time	Method
Patient anxiety	Month 12	Generalized Anxiety Disorder-7 (GAD-7) score
Number of days of alcohol consumption in the past 4 weeks	Month 12	Timeline Follow Back (TLFB) interview
Number of days of heavy alcohol consumption in the past 4 weeks	Month 12	Timeline Follow Back (TLFB) interview
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; after Cyberball task
Percentage of heavy drinking days in the past 4 weeks	Month 12	Timeline Follow Back (TLFB) interview
Adverse childhood events	Day 0	Adverse childhood events (ACE) score
Patient self-stigma due to alcohol dependence	Day 0	Self-stigma in Alcohol Dependence (SSAD) scale score
Current treatments	Day 0	List of current treatments taken from patient medical file
Patient level of distress due to rejection	Day 0; after Cyberball task	Need Threat Scale (NTS) score
Patient depression	Month 12	Patient Health Questionnaire (PHQ-9) score
Lifetime history of suicide attempts	Day 0	Number
Patient dispositional (i.e. trait) empathy	Day 0	Interpersonal reactivity index (IRI) score

Trial Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nîmes, France