The Effects of Cognitive Training on Alcohol Consumption, Cognition and Craving in Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in alcohol consumption and Working memory function
研究概览
简要总结
To purpose of the present study is to investigate the feasibility and efficacy of a computerized working memory training in improving cognitive functioning and alcohol use outcomes, in individuals with alcohol use disorders.
详细描述
This study will employ a randomized, placebo-controlled, double blind design. The intervention group will perform repeated cognitive training (5 sessions à 30-40 min / week) with increased difficulty during 5 consecutive weeks using the Cogmed® software. The non-intervention group however, will perform the same training tasks, but without the increase in difficulty. Thus our study controls for non-specific effects such as regular use of computer, adhering to a training program and expectation effects. In order the complete the study, each participant has to complete minimum 20 training sessions within a maximum time period of 6 weeks. The study will be conducted at the Center for Dependence Disorders in Stockholm, situated within the premises of the Karolinska University Hospital.
The Research Subjects:
They study will include 50 subjects with a diagnosis of alcohol use disorder. Research subjects will be recruited through public advertisement and from within the Center for Dependence Disorders in Stockholm. After an initial brief telephone screening, potential subjects will be invited to the clinic at the Karolinska University Hospital, Stockholm and screened in-person for study participation.
The Study intervention: Cogmed® Training Program Cogmed® working memory training is a computer program that will be administered online. The program consists of 7 verbal and non-verbal working memory tasks and gives immediate performance feedback to the subject undergoing training. Each training session is 90 trials and lasts for approximately 30 minutes per day, 5 days a week and during a total training period of 5 weeks (i.e. total training time approximately 12,5 hours). In order to complete the study each subject must complete 20 - 25 training sessions within maximum 6 weeks. The program adjusts the difficulty of the different tasks trial-by-trial, which allows for each subject to train at a level adjusted to his or her current WM capacity (see (Klingberg et al. 2005) for detailed description). As a control condition, equivalent to the placebo arm in a pharmaceutical trial, the Cogmed® program consists of a Standard Training program that lets the user train the same tasks but without the increase in difficulty. Thus it allows clinical trials of the software to control for non-specific effects such as regular use of computer, adhering to a training program and expectation effects.
The Study Procedures After inclusion-visit, subjects will come back to the clinic for weekly follow-up visits over the span of 5 weeks. The visits can be scheduled ±3 days from the outline below, to accommodate the schedule of each subject.
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
- Double (Participant, Investigator)
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
- •Male or a non-pregnant/non-nursing female
- •Minimum of nine years of education
- •AUDIT > 11 (performed at tele-screening) and scores 3 or 4 points on first AUDIT question (drinks 2-3 times per week or more)
- •Fulfils the DSM-5 criteria for Alcohol Use Disorder
- •Minimum 3 and maximum 14 alcohol-free days before day of inclusion (including day of inclusion)
- •Access to a home computer with internet connection during the study
- •Be willing to give informed consent and comply with study procedures
排除标准
- •Fulfils current DSM IV diagnosis of any other substance dependence disorder (except nicotine)
- •Fulfils current DSM IV diagnosis of the any major psychiatric disorder such as schizophrenia, bipolar disorder or severe major depression
- •Suicidal ideation at screening
- •Homelessness
- •Acute withdrawal in need of pharmacological treatment (Ciwa score > 14) on day of inclusion
- •Previous withdrawal-induced delirium tremens or seizures
- •Regular intake of psychotropic medication (including acamprosate, naltrexone, disulfiram, antipsychotics, mood stabilizers, antiepileptic medication, benzodiazepines) the last 6 months before screening (exceptions include SSRI against anxiety or depressive illness currently in remission + temporary use of benzodiazepiner against withdrawal and non addictive substances e.g. prometazin (Lergigan®), propiomazin (Propavan®), alimemazin (Theralen®) or hydroxizin (Atarax®)
- •Presence of non-stabilized severe medical illness e.g. liver cirrhosis, untreated severe essential hypertension (>160/100 mm Hg), uncontrolled diabetes mellitus, ischaemic heart disease, epilepsy
- •History of stroke, intracranial hemorrhage or severe head trauma/traumatic brain injury
- •Impaired sense of smell
- •Use of any illegal drugs for the last 30 days
- •Traces of alcohol as measured by breathalyzer on the Inclusion or Test day
- •Traces of any other psychoactive substance (e.g. central stimulant amines, THC, benzodiazepines, opiates, cocaine) in urine sample on inclusion day or during the course of the study
研究组 & 干预措施
Cogmed Training
Cogmed® working memory training is a computer program that will be administered online. The program consists of 7 verbal and non-verbal working memory tasks and gives immediate performance feedback to the subject undergoing training.
干预措施: Cogmed training (Behavioral)
Standard training
Individuals randomised to the placebo arm will receive a standard training online program from Cogmed also consisting of 90 trials to be performed 5 days a week and during a total training period of 5 weeks. In order to complete the study each subject must complete 20 - 25 training sessions within maximum 6 weeks. The program does not increase in difficultly level.
干预措施: Standard Training (Behavioral)
结局指标
主要结局
Change in alcohol consumption and Working memory function
时间窗: Pre and Post Study which is at baseline ( week 0) and end of study (5)
The difference in alcohol consumption (change from baseline) between the intervention and non-intervention group will be assessed by Time Line Follow Back (TLFB) outcome "percent of heavy drinking days" (heavy drinking day = 4/5 standard drinks in one day for women/men). Change in working memory function will be assessed by score on the Digit Span task and the CANTAB® visuospatial working memory task (high-function mode) pre and post treatment
次要结局
- Total number of standard drinks(On a weekly basis, at baseline, weeks 1-5)
- Craving(At every visit)
- Executive function(Pre and post study, at baseline ( week 0) and end of study ( week5))
研究者
Nitya Jayaram-Lindstrom
Phd, Assistant Professor
Karolinska University Hospital