Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder

Alcohol-Induced Disorders Clinical Trial

— TRAC  

Official title:

Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05787106
• Other study ID #: NIMAO/2022-2/AL-01
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Amandine Luquiens
• Phone: 04.66.68.69.98
• Email: amandine.luquiens[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

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a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol-Induced Disorders
• Alcoholism

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Percentage of heavy drinking days in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 3
Primary	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
Primary	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
Primary	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	Adverse childhood events	Adverse childhood events (ACE) score	Day 0
Secondary	Patient level of distress due to rejection	Need Threat Scale (NTS) score	Day 0; after Cyberball task
Secondary	Patient self-stigma due to alcohol dependence	Self-stigma in Alcohol Dependence (SSAD) scale score	Day 0
Secondary	Patient depression	Patient Health Questionnaire (PHQ-9) score	Day 0
Secondary	Patient depression	Patient Health Questionnaire (PHQ-9) score	Month 3
Secondary	Patient depression	Patient Health Questionnaire (PHQ-9) score	Month 6
Secondary	Patient depression	Patient Health Questionnaire (PHQ-9) score	Month 12
Secondary	Patient anxiety	Generalized Anxiety Disorder-7 (GAD-7) score	Day 0
Secondary	Patient anxiety	Generalized Anxiety Disorder-7 (GAD-7) score	Month 3
Secondary	Patient anxiety	Generalized Anxiety Disorder-7 (GAD-7) score	Month 6
Secondary	Patient anxiety	Generalized Anxiety Disorder-7 (GAD-7) score	Month 12
Secondary	Number of days of alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 3
Secondary	Number of days of alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 6
Secondary	Number of days of alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 12
Secondary	Number of days of heavy alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 3
Secondary	Number of days of heavy alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 6
Secondary	Number of days of heavy alcohol consumption in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 12
Secondary	Percentage of heavy drinking days in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 3
Secondary	Percentage of heavy drinking days in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 6
Secondary	Percentage of heavy drinking days in the past 4 weeks	Timeline Follow Back (TLFB) interview	Month 12
Secondary	Lifetime history of suicide attempts	Number	Day 0
Secondary	Current treatments	List of current treatments taken from patient medical file	Day 0
Secondary	Patient dispositional (i.e. trait) empathy	Interpersonal reactivity index (IRI) score	Day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	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