Study of Mechanisms of Emotion Regulation in Short- and Long-term Alcohol-abstinent Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Heart Rate Variability
研究概览
简要总结
Background:
Difficulties in assigning and identifying emotional states, or to regulate the emotional costs are recognized as one of the major factors of relapse. This study aimed to evaluate the emotion regulation processes, in short term (STA, after 1month of withdrawal) and long-term alcohol abstinent individuals (LTA, at least six months of abstinence), compared to healthy control participants (C) in a positive and negative emotion induction protocol.
Main aim:
Evaluating the emotional regulation deficits assessed with physiological indicators (heart rate variability, electrodermal response, pupil diameter) and clinically in presentations of visual stimuli to emotional value (positive, negative, neutral) in alcohol use disorder's (AUD) patients with short and long term abstinent compared to a control group of healthy subjects. The investigators are particularly interested in the evolution of heart rate variability considered as a good marker of vulnerability to AUD.
Secondary objectives:
Studying the relationships between physiological measures and clinical variables such as behavioral indicators and self-reported assessment of cognitive and emotional skills among the three groups (STA, LTA and C).
详细描述
The recording was performed for all participants during presentation of high emotional inducing stimuli presenting human interactions (pictures and video sequences). For each participant physiological responses (pupil diameter, heart rate, and skin conductance) were recorded before, during and after induction.
Participants were asked to evaluate the intensity and the valence of emotional stimuli.
In addition, a neurological evaluation, a clinical and cognitive assessment were performed.
Neurological, clinical and cognitive evaluation - Each participant had a clinical structured interview, a neurological evaluation, self-administered assessment (Hospital Anxiety & Depression Scale, Emotional Skills Profile, Obsessive Compulsive Drinking Scale, and cognitive assessment (Montreal Cognitive Assessment).
Physiological assessment - The recording was performed for all participants during the presentation of pictures (static stimuli) or videos (dynamic stimuli) selected according to their high emotional intensity (positive, neutral and negative valence), representing human interactions. For each participant heart rate, electrodermal activity, and pupil diameter were recorded during three experimental conditions: rest, induction (presentation of stimuli) and after induction (recovery). Participants were asked to evaluate the intensity and valence of the pictures and videos using the Self-Assessment Manikin.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For STA and LTA groups :
- •a diagnosis of severe alcohol use disorder (DSM5 criteria, 2013 confirmed by an addictonologist and a psychologist),
- •successful completion of withdrawal,
- •an intended treatment length of at least 1 month (for the STA group) or at least 6 months (for the LTA group).
- •For Control participants (C) :
- •social drinkers, and were recruited from the general population (e.g. at the university).
排除标准
- •with delusional psychiatric disorders (and/or medication for psychiatric disorders (excepted anxiolytics),
- •neurological or cardiological disorders,
- •taking medication that may act on heart rate or alter the regulation of body temperature or cognitive functions,
- •with active co-dependence (except for tobacco)
结局指标
主要结局
Heart Rate Variability
时间窗: 3 years
High measuring heart rate
次要结局
- pupil diameter(3 years)
- Electrodermal response(3 years)
- HAD score(3 years)
- MocA assessment(3 years)