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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.
Full description
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.
Telephone screening:
AUDIT questionnaire will be administered through the telephone. If the subject has a total score > 16 and at least 3 points on question number 1 (3-4 drinks per week or more) the subject will called in for a screening visit.
Screening Written and verbal research subject information about the study details from the study physician. Data will be collected on a number of items related to current alcohol use and life time history of dependence. In addition scales related to physical well being and trauma will also be collected.
The following is the procedure for the inclusion and for the treatment period:
Day 1: Inclusion ( week 0)
Randomization procedure Randomization will be done according to a randomised block design. The total sample size is 50 individuals. The personal login for each subject is associated with either active or control training - however neither study coordinator or the subjects know which group they are since this is not evident during the first day of training.
Study period: (Week 1-Week 5)
Week 1: Follow-up visit Day 7
Week 2, 3 and 4 Follow up visits
• Same procedure as Week 1
Week 5: Test Day (Day 35)
Other measures:
Urine Analysis:
Urine sample will be taken at every visit to the clinic in order to analyze presence of psychoactive substances (screening, inclusion and test day) and for analysis of U-ethylglucoronide (inclusion, every week visit and test day).
Breathalyser:
At each visit at the clinic, the research subjects will be tested for presence of alcohol using the alcohol breathalyser (Lion S-D2).
Blood Samples:
Each subject will leave blood samples for the bio-bank for genetic analysis and plasma and serum analysis of inflammatory markers, neuroendocrine hormones etc which will be analyzed after the completion of study. Total blood sampling for the bio-bank will be 28 ml of blood.
Physiological Measurements:
Heart rate and blood pressure will be measured by study nurse, on each visit to the clinic.
Participant Information and Consent:
In accordance with the Declaration of Helsinki, all potential research subjects will be competent and adequately informed by the investigator of every relevant aspect of the study before consenting to participate. Both oral and written information will be given, addressing the aims, methods, sources of funding, institutional affiliations of the researchers, the benefits and potential risks of the study and the discomfort it may entail.
The potential research subject will also be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the potential subject has understood the information, the investigator will seek the potential subject's freely-given written informed consent.
Ethical Considerations:
Risk/Benefit Ratio of the Study The risks involved in this study are justified by the anticipated benefits for the participants. Besides the potential benefit of the intervention, the patients establish contact with addiction healthcare professionals, which hopefully will encourage them to enroll in treatment programs. Thus, many patients with AUD that never had any treatment will be referred to treatment after the study. Furthermore, research subjects will also be compensated with 50 SEK / completed training session (maximum 25 x 50 = 1250) and additional 100-200 SEK depending on their choice on the Kirby Monetary Choice Questionnaire.
Potential risks for the individual subject are discussed below:
Potential Risks:
It is not anticipated that subject enrollment in the present study will cause any significant health related risks. However, the following potential risks are recognized:
Procedures for Minimizing Potential Risks:
Power Estimation:
We base our power estimation on effect sizes reported by Klingberg (2010) in a review of previous studies on computerized cognitive training. Difference between active and control groups regarding pre/post-test performance on working memory tasks have been around 40 % for trained tasks and 15 % for untrained tasks, with an effect size of approximately 1.0 (Cohens d). However, effect sizes for improvement in other cognitive or reasoning tasks have been weaker (around 0.4).
Given an effect size of 1.0, alpha level of 0.05 and power of 0.80 a sample size of 36 is sufficient in order to detect a difference between the groups regarding working memory improvement (calculated using STATA software power program). Thus, our sample size of 50 is adequate.
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50 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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