Effect of Cognitive Training on Alcohol Use Outcomes

NCT02113618 | Completed DMC

• 1 other identifier: COGALC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorders

Keywords

Cognitive function, alcohol dependence, working memory

Outcome Measures

Primary Outcomes (1)

• Change in alcohol consumption and Working memory function

  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

  Pre and Post Study which is at baseline ( week 0) and end of study (5)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Cogmed Training

ACTIVE COMPARATOR

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.

Behavioral: Cogmed training

Standard training

PLACEBO COMPARATOR

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.

Behavioral: Standard Training

Interventions

Cogmed training BEHAVIORAL

Cogmed® working memory training session consists 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 Working memory capacity

Cogmed Training

Standard Training BEHAVIORAL

Standard training session in an online training and also consists 90 trials and lasts for approximately 30 minutes per day, 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

Standard training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Access to a home computer with internet connection during the study
• Be willing to give informed consent and comply with study procedures

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Center for Dependence Disorders

Stockholm, Stockholm County, 17176, Sweden

Location

Related Publications (1)

• Khemiri L, Brynte C, Stunkel A, Klingberg T, Jayaram-Lindstrom N. Working Memory Training in Alcohol Use Disorder: A Randomized Controlled Trial. Alcohol Clin Exp Res. 2019 Jan;43(1):135-146. doi: 10.1111/acer.13910. Epub 2018 Nov 21.

  PMID: 30462837 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Nitya Jayaram-Lindstrom, PhD

  Karolinska Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd, Assistant Professor

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 14, 2014
• Study Start: October 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

SE (1)