Alcohol-Induced DisordersTRACNCT05787106
Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder
A study testing Cyberball task in people with Alcohol-Induced Disorders and Ostracism, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol-Induced Disorders, Ostracism
- What is being tested?
- Cyberball task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2023to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alcohol-Induced Disorders, Ostracism
- Being tested
- Cyberball task
- Keywords
- Adverse childhood experiences, Rejection
- Medical subject headings
- Alcohol-Induced Disorders, Ostracism, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyberball taskOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PAtients withdrawn from alcohol | Experimental | Not described Receives: Other: Cyberball task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0; before Cyberball task
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.
Measured: Day 0; after Cyberball task
Percentage of heavy drinking days in the past 4 weeks
Timeline Follow Back (TLFB) interview
Measured: Month 3
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
Measured: Day 0; before Cyberball task
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
Measured: Day 0; after Cyberball task
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
Measured: Month 3
Secondary outcomes (27)
Adverse childhood events
Adverse childhood events (ACE) score
Measured: Day 0
Patient level of distress due to rejection
Need Threat Scale (NTS) score
Measured: Day 0; after Cyberball task
Patient self-stigma due to alcohol dependence
Self-stigma in Alcohol Dependence (SSAD) scale score
Measured: Day 0
Patient depression
Patient Health Questionnaire (PHQ-9) score
Measured: Day 0
Patient depression
Patient Health Questionnaire (PHQ-9) score
Measured: Month 3
Patient depression
Patient Health Questionnaire (PHQ-9) score
Measured: Month 6
Patient depression
Patient Health Questionnaire (PHQ-9) score
Measured: Month 12
Patient anxiety
Generalized Anxiety Disorder-7 (GAD-7) score
Measured: Day 0
Patient anxiety
Generalized Anxiety Disorder-7 (GAD-7) score
Measured: Month 3
Patient anxiety
Generalized Anxiety Disorder-7 (GAD-7) score
Measured: Month 6
Patient anxiety
Generalized Anxiety Disorder-7 (GAD-7) score
Measured: Month 12
Number of days of alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Measured: Month 3
Number of days of alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Measured: Month 6
Number of days of alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Measured: Month 12
Number of days of heavy alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Measured: Month 3
Number of days of heavy alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Measured: Month 6
Number of days of heavy alcohol consumption in the past 4 weeks
Timeline Follow Back (TLFB) interview
Measured: Month 12
Percentage of heavy drinking days in the past 4 weeks
Timeline Follow Back (TLFB) interview
Measured: Month 3
Percentage of heavy drinking days in the past 4 weeks
Timeline Follow Back (TLFB) interview
Measured: Month 6
Percentage of heavy drinking days in the past 4 weeks
Timeline Follow Back (TLFB) interview
Measured: Month 12
Lifetime history of suicide attempts
Number
Measured: Day 0
Current treatments
List of current treatments taken from patient medical file
Measured: Day 0
Patient dispositional (i.e. trait) empathy
Interpersonal reactivity index (IRI) score
Measured: Day 0
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Positive And Negative Affect Schedule (PANAS) after the rejection situation.
Measured: Day 0; before Cyberball task
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Positive And Negative Affect Schedule (PANAS) after the rejection situation.
Measured: Day 0; after Cyberball task
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.
Measured: Day 0; before Cyberball task
Concurrent validity of the Adult rejection Sensitivity Questionnaire (A-RSQ) with the Need Threat Scale (NTS) after the rejection situation.
Measured: Day 0; after Cyberball task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start31 May 2023
- Primary completion15 Jan 2025
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-Induced DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amandine Luquiens, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787106
- Sponsor's protocol ID
- NIMAO/2022-2/AL-01
- Acronym
- TRAC
- Status last verified
- Feb 2025
- First submitted
- 13 Mar 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT05787106
- Acronym / sponsor ID
- TRAC / NIMAO/2022-2/AL-01
- Conditions
- Alcohol-Induced Disorders, Ostracism
- Keywords
- Adverse childhood experiences, Rejection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- Nov 2025 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAtients withdrawn from alcohol | Experimental | Other: Cyberball task |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyberball taskThe 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. | Other | PAtients withdrawn from alcohol |
Primary outcome
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.
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.
Percentage of heavy drinking days in the past 4 weeks
Time frame: Month 3
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).
Time frame: Day 0; before Cyberball task
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).
Time frame: Day 0; after Cyberball task
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).
Time frame: Month 3
Multiple linear regression
27 secondary outcomes
Adverse childhood events
Time frame: Day 0
Patient level of distress due to rejection
Time frame: Day 0; after Cyberball task
Patient self-stigma due to alcohol dependence
Time frame: Day 0
Patient depression
Time frame: Day 0
Patient depression
Time frame: Month 3
Patient depression
Time frame: Month 6
Patient depression
Time frame: Month 12
Patient anxiety
Time frame: Day 0
Patient anxiety
Time frame: Month 3
Patient anxiety
Time frame: Month 6
Patient anxiety
Time frame: Month 12
Number of days of alcohol consumption in the past 4 weeks
Time frame: Month 3
Number of days of alcohol consumption in the past 4 weeks
Time frame: Month 6
Number of days of alcohol consumption in the past 4 weeks
Time frame: Month 12
Number of days of heavy alcohol consumption in the past 4 weeks
Time frame: Month 3
Number of days of heavy alcohol consumption in the past 4 weeks
Time frame: Month 6
Number of days of heavy alcohol consumption in the past 4 weeks
Time frame: Month 12
Percentage of heavy drinking days in the past 4 weeks
Time frame: Month 3
Percentage of heavy drinking days in the past 4 weeks
Time frame: Month 6
Percentage of heavy drinking days in the past 4 weeks
Time frame: Month 12
Lifetime history of suicide attempts
Time frame: Day 0
Current treatments
Time frame: Day 0
Patient dispositional (i.e. trait) empathy
Time frame: Day 0
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amandine Luquiens principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyberball task in people with Alcohol-Induced Disorders and Ostracism, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of emotional reaction to social rejection (Cyberball game) (time frame: Day 0; before Cyberball task). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.