Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals with Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Role of emotional reaction to social rejection (Cyberball game)
研究概览
简要总结
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a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Role of emotional reaction to social rejection (Cyberball game)
时间窗: 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
时间窗: 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).
时间窗: Month 3
Multiple linear regression
次要结局
- Current treatments(Day 0)
- Patient depression(Month 12)
- Patient anxiety(Month 12)
- Number of days of alcohol consumption in the past 4 weeks(Month 12)
- Number of days of heavy alcohol consumption in the past 4 weeks(Month 12)
- 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)
- 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)
- Percentage of heavy drinking days in the past 4 weeks(Month 12)
- Adverse childhood events(Day 0)
- Patient self-stigma due to alcohol dependence(Day 0)
- Patient level of distress due to rejection(Day 0; after Cyberball task)
- Lifetime history of suicide attempts(Day 0)
- Patient dispositional (i.e. trait) empathy(Day 0)