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Active, Not Recruiting

NCT Number: NCT05787106

Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder

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a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients.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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alcohol-induced Disorders Alcohol-Related Disorders Behavior Chemically-Induced Disorders Ostracism Rejection, Psychology Social Behavior Social Isolation Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyberball task

Other

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 outcomes

  1. Role of emotional reaction to social rejection (Cyberball game)

    Time frame: Day 0; before Cyberball task

    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.

  2. Role of emotional reaction to social rejection (Cyberball game)

    Time frame: Day 0; after Cyberball task

    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.

  3. Percentage of heavy drinking days in the past 4 weeks

    Time frame: Month 3

    Timeline Follow Back (TLFB) interview

  4. 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).

    Time frame: Day 0; before Cyberball task

    Multiple linear regression

  5. 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).

    Time frame: Day 0; after Cyberball task

    Multiple linear regression

  6. 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).

    Time frame: Month 3

    Multiple linear regression

Secondary outcomes

  1. Adverse childhood events

    Time frame: Day 0

    Adverse childhood events (ACE) score

  2. Patient level of distress due to rejection

    Time frame: Day 0; after Cyberball task

    Need Threat Scale (NTS) score

  3. Patient self-stigma due to alcohol dependence

    Time frame: Day 0

    Self-stigma in Alcohol Dependence (SSAD) scale score

  4. Patient depression

    Time frame: Day 0

    Patient Health Questionnaire (PHQ-9) score

  5. Patient depression

    Time frame: Month 3

    Patient Health Questionnaire (PHQ-9) score

  6. Patient depression

    Time frame: Month 6

    Patient Health Questionnaire (PHQ-9) score

  7. Patient depression

    Time frame: Month 12

    Patient Health Questionnaire (PHQ-9) score

  8. Patient anxiety

    Time frame: Day 0

    Generalized Anxiety Disorder-7 (GAD-7) score

  9. Patient anxiety

    Time frame: Month 3

    Generalized Anxiety Disorder-7 (GAD-7) score

  10. Patient anxiety

    Time frame: Month 6

    Generalized Anxiety Disorder-7 (GAD-7) score

  11. Patient anxiety

    Time frame: Month 12

    Generalized Anxiety Disorder-7 (GAD-7) score

  12. Number of days of alcohol consumption in the past 4 weeks

    Time frame: Month 3

    Timeline Follow Back (TLFB) interview

  13. Number of days of alcohol consumption in the past 4 weeks

    Time frame: Month 6

    Timeline Follow Back (TLFB) interview

  14. Number of days of alcohol consumption in the past 4 weeks

    Time frame: Month 12

    Timeline Follow Back (TLFB) interview

  15. Number of days of heavy alcohol consumption in the past 4 weeks

    Time frame: Month 3

    Timeline Follow Back (TLFB) interview

  16. Number of days of heavy alcohol consumption in the past 4 weeks

    Time frame: Month 6

    Timeline Follow Back (TLFB) interview

  17. Number of days of heavy alcohol consumption in the past 4 weeks

    Time frame: Month 12

    Timeline Follow Back (TLFB) interview

  18. Percentage of heavy drinking days in the past 4 weeks

    Time frame: Month 3

    Timeline Follow Back (TLFB) interview

  19. Percentage of heavy drinking days in the past 4 weeks

    Time frame: Month 6

    Timeline Follow Back (TLFB) interview

  20. Percentage of heavy drinking days in the past 4 weeks

    Time frame: Month 12

    Timeline Follow Back (TLFB) interview

  21. Lifetime history of suicide attempts

    Time frame: Day 0

    Number

  22. Current treatments

    Time frame: Day 0

    List of current treatments taken from patient medical file

  23. Patient dispositional (i.e. trait) empathy

    Time frame: Day 0

    Interpersonal reactivity index (IRI) score

  24. 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

  25. 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

  26. 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

  27. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: TRAC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2023
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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