Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder

NCT05787106 | Active Not Recruiting

• 1 other identifier: NIMAO/2022-2/AL-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients.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

Conditions

Alcohol-Induced Disorders; Ostracism

Keywords

Adverse childhood experiences; Rejection

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (27)

• Adverse childhood events

  Day 0

• Patient level of distress due to rejection

  Day 0; after Cyberball task

• Patient self-stigma due to alcohol dependence

  Day 0

• Patient depression

  Day 0

• Patient depression

  Month 3

Study Arms (1)

PAtients withdrawn from alcohol

EXPERIMENTAL

Other: Cyberball task

Interventions

Cyberball task OTHER

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.

PAtients withdrawn from alcohol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, Nîmes, 30029, France

Location

MeSH Terms

Conditions

Alcohol-Induced Disorders; Ostracism; Rejection, Psychology

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Social Isolation; Social Behavior; Behavior

Study Officials

• Amandine Luquiens

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 28, 2023
• Study Start: May 31, 2023
• Primary Completion: January 15, 2025
• Study Completion: November 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)