Interest of Cognitive Remediation for the Reduction of Consumption in Alcohol Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- total quantity of alcohol consumed in 3 months (measured in units of pure alcohol, 1 unit = 10g of alcohol).
研究概览
简要总结
The individual and societal cost of alcohol use disorders (TUAL), present in 10% of the population in France, is considerable. Despite psychotherapeutic and drug addiction treatment, the relapse rate remains very high, partly because of their very frequent cognitive disorders. In fact, more than 75% of TUAL patients present to varying degrees neuropsychological alterations that are only rarely detected and never treated. However, these cognitive disorders limit the benefit of psychotherapeutic care, reduce compliance with pharmacological treatments and hinder the patient's ability to change his behavior with respect to alcohol. An innovative way to promote the maintenance of the therapeutic contract, and therefore to reduce alcohol consumption in these patients, would be to improve their cognitive functioning. The objective of this study is to measure the efficacy of a non-drug treatment, based on a specific and personalized cognitive remediation program, compared to a standard treatment in Day Hospitalization, in order to reduce the rate of relapse very high in TUAL. It is a randomized, single-blind study with two parallel groups of patients with post-weaning neuropsychological disorders: REMED (cognitive remediation) and CONTROL (usual care).
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient male or female aged 18 to 60, French speaking and affiliated to the social security system
- •Patient with TUAL (DSM-5) at the forefront of alcohol use disorders at the time of inclusion
- •Patient with neuropsychological disorders objectified on BEARNI (BEARNI for Brief Evaluation of Alcohol-Related Neuropsychological Evaluation, Ritz et al., 2015 cut-off cognitive score = 13, adding a point for patients with bachelor level or lower) and confirmed at the neuropsychological checkup showing pathological performance (at least two free or total recalls of RL / RI 16 <-1.65 and / or RBMT IGM <-1.65 OR number of persecutory or deficit errors at MCST <-1.65 and / or at least two BADS subtests with a score of <or = 2 (except temporal judgment)). Evaluation (BEARNI) at least 48h after stopping benzodiazepines
- •Patient weaned of alcohol, that is to say between 5 and 21 days after stopping alcohol, after disappearing signs of withdrawal (Cushman score <2) and stopping benzodiazepines
- •First hospitalization type day hospital (not necessarily first weaning)
- •Patient having been informed of the study and being able to give written informed consent.
排除标准
- •Patient with severe and long-lasting neurological complications related to alcohol (Korsakoff syndrome, fetal alcohol syndrome, ...)
- •Patient with a disorder of severe use of another psychoactive substance according to DSM-5, except tobacco
- •Patient with motor or sensory deficit making cognitive remediation impossible
- •Patient previously included or already included in another biomedical research
- •Homeless patient
结局指标
主要结局
total quantity of alcohol consumed in 3 months (measured in units of pure alcohol, 1 unit = 10g of alcohol).
时间窗: baseline until 3 month of intervention
using TimeLine-Follow-Back tracking method (TLFB)
次要结局
未报告次要终点