Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05787106
Other study ID # NIMAO/2022-2/AL-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients.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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05014087 - Digoxin In Treatment of Alcohol Associated Hepatitis Phase 2
Active, not recruiting NCT03018990 - Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial N/A
Completed NCT00568958 - Naltrexone for Heavy Drinking in Young Adults Phase 4
Completed NCT01829308 - SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers N/A
Recruiting NCT05023317 - Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care Phase 1
Enrolling by invitation NCT04234139 - Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation
Completed NCT00325299 - Magnesium After Alcohol Withdrawal Treatment Phase 4