Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 3
- 主要终点
- Inhibition Go/NoGo
研究概览
简要总结
The study aims to investigate the effects of a short computerized training as a therapeutic add-on to standard therapy in patients with alcohol-use disorder.
详细描述
Therapeutic interventions to treat alcohol use disorders (AUD) still need to be improved. A novel alcohol-specific inhibition-training seems to be a promising new intervention. In this study, recently abstinent patients with AUD attending an inpatient treatment program will be randomly assigned to one of two alcohol-specific inhibition-training groups (varying in Go/NoGo-ratio) or to a control condition. Besides the effects on drinking behavior, inhibition and implicit attitudes, the investigators expect the training to influence neurophysiological reactivity to alcohol related stimuli. A subgroup of patients will therefore additionally undergo EEG recording so that the neurophysiological effects of the training can be assessed and related to clinical outcome. Furthermore, since training effects rely on learning processes, the influence of endogenous cortisol level (a consolidation-enhancer which peaks in the morning) on training outcome will be examined by the variation of daytime of the training. All patients' inhibitory control and implicit associations towards alcohol will be measured before and after training. The training effects will be examined on proximal outcome variables (e.g. implicit associations, inhibitory control, abstinence related self-efficacy, craving) and on distal outcome variables at 3-, 6- and 12- months follow-up (e.g. percent abstinent days (primary outcome)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abstinent patients with an alcohol use disorder in the 12-week inpatient program of the Clinic Südhang or the Forel Clinic,
- •Abstained from alcohol for at least 4 weeks (in relation to timepoint when training will start),
- •Informed Consent as documented by signature.
排除标准
- •Other main psychiatric diagnosis than alcohol use disorder (comorbidity is allowed if the alcohol use disorder is to be considered the main diagnosis),
- •other severe substance use disorder (except nicotine), even as secondary diagnosis
- •Neurocognitive problems (e.g. Korsakoff syndrome),
- •Current medical conditions excluding participation (e.g. acute infectious disease),
- •Inability to read and understand the participant's information,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons.
结局指标
主要结局
Inhibition Go/NoGo
时间窗: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Inhibitory control as assessed with a Go/NoGo task.
Percent days of abstinence 3-months follow-up.
时间窗: 3-months follow-up
Percentage of abstinent days in 3-months follow-up. This will be measured with the timeline follow back (TFB), which is a validated procedure to aid recall of past drinking and evaluates information about drinking behavior.
Implicit associations (IAT)
时间窗: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Implicit associations as assessed with an alcohol-related implicit association task (IAT)
Heavy drinking days in 3 months follow-up
时间窗: 3 months follow-up
in 3-months follow-up. This will be measured Heavy drinking days in 3 months follow-up, measured with the timeline follow back (TFB), which is a validated procedure to aid recall of past drinking and evaluates information about drinking behavior.
Neurophysiology of inhibitory Control (Go/NoGo)
时间窗: Post training, i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session
Neurophysiological correlates of inhibitory control as assessed with EEG-measurement during the Go-NOGo-task. ERPs in response to NoGo-Stimuli will be calculated and the N2/p3-complex will be analyzed
次要结局
- Percent heavy drinking days(3-, 6- and 12-months follow-up)
- Craving(Post-training (i.e. between 1 and 7 days after completion of the last training session); discharge, 3-, 6- and 12-months follow-up)
- Time to first drink(3-, 6- and 12-months follow-up)
- Abstinence related self-efficacy(Post-training (i.e. between 1 and 7 days after completion of the training session); discharge, 3-, 6- and 12-months follow-up)
- Inhibition (SST)(Post-training; i.e. between 1 and 7 days after completion of the last (i.e. the 6th) training session)