Clinical trial NCT05787106: Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder
Official title: Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol-Induced Disorders
Ostracism
Keywords: Adverse childhood experiences
Rejection
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients.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


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

Primary outcomes:
measure: Role of emotional reaction to social rejection (Cyberball game)
timeFrame: Day 0; before Cyberball task
measure: Role of emotional reaction to social rejection (Cyberball game)
timeFrame: Day 0; after Cyberball task
measure: Percentage of heavy drinking days in the past 4 weeks
timeFrame: Month 3
measure: 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).
timeFrame: Day 0; before Cyberball task
measure: 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).
timeFrame: Day 0; after Cyberball task
measure: 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).
timeFrame: Month 3
Secondary outcomes:
measure: Adverse childhood events
timeFrame: Day 0
measure: Patient level of distress due to rejection
timeFrame: Day 0; after Cyberball task
measure: Patient self-stigma due to alcohol dependence
timeFrame: Day 0
measure: Patient depression
timeFrame: Day 0
measure: Patient depression
timeFrame: Month 3
measure: Patient depression
timeFrame: Month 6
measure: Patient depression
timeFrame: Month 12
measure: Patient anxiety
timeFrame: Day 0
measure: Patient anxiety
timeFrame: Month 3
measure: Patient anxiety
timeFrame: Month 6
measure: Patient anxiety
timeFrame: Month 12
measure: Number of days of alcohol consumption in the past 4 weeks
timeFrame: Month 3
measure: Number of days of alcohol consumption in the past 4 weeks
timeFrame: Month 6
measure: Number of days of alcohol consumption in the past 4 weeks
timeFrame: Month 12
measure: Number of days of heavy alcohol consumption in the past 4 weeks
timeFrame: Month 3
measure: Number of days of heavy alcohol consumption in the past 4 weeks
timeFrame: Month 6
measure: Number of days of heavy alcohol consumption in the past 4 weeks
timeFrame: Month 12
measure: Percentage of heavy drinking days in the past 4 weeks
timeFrame: Month 3
measure: Percentage of heavy drinking days in the past 4 weeks
timeFrame: Month 6
measure: Percentage of heavy drinking days in the past 4 weeks
timeFrame: Month 12
measure: Lifetime history of suicide attempts
timeFrame: Day 0
measure: Current treatments
timeFrame: Day 0
measure: Patient dispositional (i.e. trait) empathy
timeFrame: Day 0
measure: Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Positive And Negative Affect Schedule (PANAS) after the rejection situation.
timeFrame: Day 0; before Cyberball task
measure: Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Positive And Negative Affect Schedule (PANAS) after the rejection situation.
timeFrame: Day 0; after Cyberball task
measure: Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.
timeFrame: Day 0; before Cyberball task
measure: Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.
timeFrame: Day 0; after Cyberball task
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Amandine Luquiens
role: PRINCIPAL_INVESTIGATOR
References: