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Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder

Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05787106
Acronym
TRAC
Enrollment
58
Registered
2023-03-28
Start date
2023-05-31
Completion date
2025-11-30
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol-Induced Disorders, Ostracism

Keywords

Adverse childhood experiences, Rejection

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a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients.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

Interventions

OTHERCyberball 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Role of emotional reaction to social rejection (Cyberball game)Day 0; before Cyberball taskPositive 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 weeksMonth 3Timeline 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).Day 0; before Cyberball taskMultiple linear regression

Secondary

MeasureTime frameDescription
Patient depressionDay 0Patient Health Questionnaire (PHQ-9) score
Patient anxietyDay 0Generalized Anxiety Disorder-7 (GAD-7) score
Number of days of alcohol consumption in the past 4 weeksMonth 3Timeline Follow Back (TLFB) interview
Number of days of heavy alcohol consumption in the past 4 weeksMonth 3Timeline Follow Back (TLFB) interview
Percentage of heavy drinking days in the past 4 weeksMonth 3Timeline Follow Back (TLFB) interview
Adverse childhood eventsDay 0Adverse childhood events (ACE) score
Current treatmentsDay 0List of current treatments taken from patient medical file
Patient dispositional (i.e. trait) empathyDay 0Interpersonal reactivity index (IRI) score
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 Need Threat Scale (NTS) after the rejection situation.Day 0; before Cyberball task
Lifetime history of suicide attemptsDay 0Number
Patient level of distress due to rejectionDay 0; after Cyberball taskNeed Threat Scale (NTS) score
Patient self-stigma due to alcohol dependenceDay 0Self-stigma in Alcohol Dependence (SSAD) scale score

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026