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Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder (TRAC)

Primary Purpose

Alcohol-Induced Disorders, Ostracism

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cyberball task
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol-Induced Disorders focused on measuring Adverse childhood experiences, Rejection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de NîmesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PAtients withdrawn from alcohol

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
Percentage of heavy drinking days in the past 4 weeks
Timeline 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).
Multiple linear regression
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
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

Secondary Outcome Measures

Adverse childhood events
Adverse childhood events (ACE) score
Patient level of distress due to rejection
Need Threat Scale (NTS) score
Patient self-stigma due to alcohol dependence
Self-stigma in Alcohol Dependence (SSAD) scale score
Patient depression
Patient Health Questionnaire (PHQ-9) score
Patient depression
Patient Health Questionnaire (PHQ-9) score
Patient depression
Patient Health Questionnaire (PHQ-9) score
Patient depression
Patient Health Questionnaire (PHQ-9) score
Patient anxiety
Generalized Anxiety Disorder-7 (GAD-7) score
Patient anxiety
Generalized Anxiety Disorder-7 (GAD-7) score
Patient anxiety
Generalized Anxiety Disorder-7 (GAD-7) score
Patient anxiety
Generalized Anxiety Disorder-7 (GAD-7) score
Number of days of alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Number of days of alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Number of days of alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Number of days of heavy alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Number of days of heavy alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Number of days of heavy alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Percentage of heavy drinking days in the past 4 weeks
Timeline Follow Back (TLFB) interview
Percentage of heavy drinking days in the past 4 weeks
Timeline Follow Back (TLFB) interview
Percentage of heavy drinking days in the past 4 weeks
Timeline Follow Back (TLFB) interview
Lifetime history of suicide attempts
Number
Current treatments
List of current treatments taken from patient medical file
Patient dispositional (i.e. trait) empathy
Interpersonal 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.
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Positive And Negative Affect Schedule (PANAS) after the rejection situation.
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.

Full Information

First Posted
March 13, 2023
Last Updated
September 7, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT05787106
Brief Title
Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder
Acronym
TRAC
Official Title
Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Induced Disorders, Ostracism
Keywords
Adverse childhood experiences, Rejection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PAtients withdrawn from alcohol
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cyberball task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Role of emotional reaction to social rejection (Cyberball game)
Description
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.
Time Frame
Day 0; before Cyberball task
Title
Role of emotional reaction to social rejection (Cyberball game)
Description
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.
Time Frame
Day 0; after Cyberball task
Title
Percentage of heavy drinking days in the past 4 weeks
Description
Timeline Follow Back (TLFB) interview
Time Frame
Month 3
Title
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).
Description
Multiple linear regression
Time Frame
Day 0; before Cyberball task
Title
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).
Description
Multiple linear regression
Time Frame
Day 0; after Cyberball task
Title
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).
Description
Multiple linear regression
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Adverse childhood events
Description
Adverse childhood events (ACE) score
Time Frame
Day 0
Title
Patient level of distress due to rejection
Description
Need Threat Scale (NTS) score
Time Frame
Day 0; after Cyberball task
Title
Patient self-stigma due to alcohol dependence
Description
Self-stigma in Alcohol Dependence (SSAD) scale score
Time Frame
Day 0
Title
Patient depression
Description
Patient Health Questionnaire (PHQ-9) score
Time Frame
Day 0
Title
Patient depression
Description
Patient Health Questionnaire (PHQ-9) score
Time Frame
Month 3
Title
Patient depression
Description
Patient Health Questionnaire (PHQ-9) score
Time Frame
Month 6
Title
Patient depression
Description
Patient Health Questionnaire (PHQ-9) score
Time Frame
Month 12
Title
Patient anxiety
Description
Generalized Anxiety Disorder-7 (GAD-7) score
Time Frame
Day 0
Title
Patient anxiety
Description
Generalized Anxiety Disorder-7 (GAD-7) score
Time Frame
Month 3
Title
Patient anxiety
Description
Generalized Anxiety Disorder-7 (GAD-7) score
Time Frame
Month 6
Title
Patient anxiety
Description
Generalized Anxiety Disorder-7 (GAD-7) score
Time Frame
Month 12
Title
Number of days of alcohol consumption in the past 4 weeks
Description
Timeline Follow Back (TLFB) interview
Time Frame
Month 3
Title
Number of days of alcohol consumption in the past 4 weeks
Description
Timeline Follow Back (TLFB) interview
Time Frame
Month 6
Title
Number of days of alcohol consumption in the past 4 weeks
Description
Timeline Follow Back (TLFB) interview
Time Frame
Month 12
Title
Number of days of heavy alcohol consumption in the past 4 weeks
Description
Timeline Follow Back (TLFB) interview
Time Frame
Month 3
Title
Number of days of heavy alcohol consumption in the past 4 weeks
Description
Timeline Follow Back (TLFB) interview
Time Frame
Month 6
Title
Number of days of heavy alcohol consumption in the past 4 weeks
Description
Timeline Follow Back (TLFB) interview
Time Frame
Month 12
Title
Percentage of heavy drinking days in the past 4 weeks
Description
Timeline Follow Back (TLFB) interview
Time Frame
Month 3
Title
Percentage of heavy drinking days in the past 4 weeks
Description
Timeline Follow Back (TLFB) interview
Time Frame
Month 6
Title
Percentage of heavy drinking days in the past 4 weeks
Description
Timeline Follow Back (TLFB) interview
Time Frame
Month 12
Title
Lifetime history of suicide attempts
Description
Number
Time Frame
Day 0
Title
Current treatments
Description
List of current treatments taken from patient medical file
Time Frame
Day 0
Title
Patient dispositional (i.e. trait) empathy
Description
Interpersonal reactivity index (IRI) score
Time Frame
Day 0
Title
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Positive And Negative Affect Schedule (PANAS) after the rejection situation.
Time Frame
Day 0; before Cyberball task
Title
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Positive And Negative Affect Schedule (PANAS) after the rejection situation.
Time Frame
Day 0; after Cyberball task
Title
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.
Time Frame
Day 0; before Cyberball task
Title
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.
Time Frame
Day 0; after Cyberball task

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amandine Luquiens
Phone
04.66.68.69.98
Email
amandine.luquiens@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amandine Luquiens
Organizational Affiliation
CHU de Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Amandine Luquiens
First Name & Middle Initial & Last Name & Degree
Anouk Lequien
First Name & Middle Initial & Last Name & Degree
Alexia Beaufils
First Name & Middle Initial & Last Name & Degree
Valérie Ewert

12. IPD Sharing Statement

Learn more about this trial

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

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