Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder

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a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients.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

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Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder

Conditions
-----------------
Alcohol-Induced Disorders, Ostracism

Intervention / Treatment
-----------------
* Other: Cyberball task


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAtients withdrawn from alcohol<br> | Other: Cyberball task<br>* 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.<br>|

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 |
| --- | --- | --- |
| 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 3 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adverse childhood experiences, Rejection