The effect of memory training on alchohol use.|
|- candidate number||10515|
|- NTR Number||NTR3152|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-nov-2011|
|- Secondary IDs||NL38350.068.11 / 11-3-067; CCMO and METC azM/UM|
|- Public Title||The effect of memory training on alchohol use.|
|- Scientific Title||The effect of internet-based working memory training on automatic preferences for alcohol use in a clinical sample.|
|- hypothesis||The primary aim of this study is to investigate the effect of a computer-based WMT on executive functioning (and especially WM performance) in a clinical sample of alcohol dependent subjects. Secondly, we will examine if an improvement in WM is related to improved control over drinking behaviour (e.g. the amount of consumed alcohol beverages and alcohol cravings). Thirdly, we are interested whether this improvement in cognitive functioning is additional to the effect of the regular treatment, especially in the long run. |
|- Healt Condition(s) or Problem(s) studied||Alcohol dependence|
|- Inclusion criteria||1. Alcohol dependence: diagnosed according to criteria DSM IV (American Psychiatric Association, 2000);|
2. Participants will be screened with the Alcohol Use Disorder Identification Test (AUDIT; Saunders et al.1993), and are only allowed to participate when they score 8 or higher on the AUDIT (i.e., the cut-off score for hazardous drinking; Saunders et al. 1993);
3. Age over 18 years;
4. A minimum of 4 years of formal schooling and no history of mental retardation;
5. Native Dutch speaker;
6. Mental competency to give informed consent. Mental competency as defined by the Dutch law (WGBO: Wet of Geneeskundige Behandel Overeenkomst) is determined by the medical specialist (e.g. psychiatrist) based on the patientís health record, observations and conversation with the regular therapist. If necessary, the psychiatrist will have a short conversation with the patient. The concerning psychiatrists are: Dr. Michael Wellner, Dr. Robert Hilse, Dr. Claudia Decker and Dr. An Joos. They are all employees of Addiction Care of the Mondriaan Zorggroep;
7. Participants must have access (preferable at their own home) to a computer with an internet connection.
|- Exclusion criteria||1. AUDIT score lower than 8 (the cut-off score for hazardous drinking; Saunders et al. 1993);|
2. History of acquired brain injury (e.g. cerebral contusion, cerebrovascular accident);
3. Participants who show signs of poor compliance (e.g. not completing a session in time and session loss) and/or poor response on the questionnaires will be excluded from the experiment by the researchers;
4. Polydrug users, people who use more than one drug, are excluded from the study.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2012|
|- planned closingdate||30-jun-2012|
|- Target number of participants||168|
|- Interventions||The working memory training (WMT) used in the present study is based on the exact same tasks used in the study of Houben, Wiers and Jansen (2011) and the results of this study were promising. The participants in this study showed an improvement in WM performance after WMT. Their WMT was based on the ideas, tasks and studies of Klingberg and associates (e.g. 2002). The daily exercises are designed to train both the visuo-spatial and verbal WM.|
All participants (in both the training and control conditions) will be tested during the WMT on three kind of WM tests: the visuospatial WM span task, the backwards digit span task, and the letter span task (based on Klingberg et al., 2002). All three tasks consist of 30 trials.
1. Visuospatial WM task: During this task, a certain number of squares in a 4x4 grid
changed in colour on the computer screen. Participants have to reproduce this
sequence by clicking on the squares that have changed colour in the correct order
using the computer mouse;
2. Backward digit span: During this task, a sequence of numbers will be presented on
the computer screen. Participants have to reproduce this sequence in reversed order,
using either the computer mouse or the number keys on the keyboard;
3. Letter span task: During this task, a sequence of letters will be presented on the
computer screen in a circle. One of the positions in this circle is the be indicated and participants have to reproduce the corresponding letter using the keyboard.
In the training condition (participants in the experimental group (group 3)), the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. Initially, each task involved sequences of three items. The length of the sequences will increase and decrease
according to participantsí performance. When participants correctly reproduce the sequences on two consecutive trials, one item will be added to the sequence on the next trial. When participants are not able to correctly reproduce the sequences on two consecutive trials, the sequence in the next trial will contain one item fewer.
In the control condition (participants in group 2), the difficulty level of the WM tasks will not be adjusted, remaining at the initial, easy level throughout each task (i.e., three items in each sequence).
|- Primary outcome||1. Working memory performance: See interventions for the description of the tasks;|
2. Automatic impulses: The Implicit Association Test (IAT) will be used as an index of automatic impulses to drink alcohol; automatic (or implicit) preferences for alcohol will be measured (Greenwald et al. 1998; Houben & Wiers 2009). The IAT is a reaction time task that required participants to sort stimuli into two target categories, alcohol and soft drink and two attribute categories, pleasant and unpleasant. Items representing the four categories will be presented one at a time, and participants have to categorize them as quickly as possible.
|- Secondary outcome||1. Alcohol use;|
2. Relapse rate;
3. Executive functioning;
5. Approach/avoidance of alcohol;
10. Psychological state;
|- Timepoints||Neuropsychological assessment before the start of the experiment. At pretest, posttest and follow-up, several questionnaires and tests will be administered.|
|- Trial web site||https://www.emium.nl/soto/users/khouben/_demowm/ |
|- CONTACT FOR PUBLIC QUERIES||BSc. Kay Deckers|
|- CONTACT for SCIENTIFIC QUERIES||BSc. Kay Deckers|
|- Sponsor/Initiator ||University Maastricht (UM), Mondriaan|
(Source(s) of Monetary or Material Support)
|University Maastricht (UM), Mondriaan Zorggroep|
|- Brief summary||Rationale:|
Alcohol abuse causes disruptions in the human cognitive domain. For instance planning, attention, inhibition of inappropriate actions and working memory are affected by long-term alcohol abuse. It has been shown that an impairment of the aforementioned executive functions may result in maladaptive behaviour. For instance, drinking behaviour can get out of control, due to the fact that automatic impulses may not be suppressed appropriately. Working memory forms/is the basis for learning, planning, organizing, staying focused, control of impulses and reasoning. For this reason, the present study will investigate
whether working memory training can strengthen executive control and thereby maybe overcome the aforementioned deficits.
The primary aim of this study is to investigate the effect of a computer-based
WMT on executive functioning (and especially WM performance) in a clinical sample of alcohol dependent subjects. Secondly, we will examine if an improvement in WM is related to
improved control over drinking behaviour (e.g. the amount of consumed alcohol beverages and alcohol cravings). Thirdly, we are interested whether this improvement in cognitive functioning is additional to the effect of the regular treatment, especially in the long run.
Split-plot design (double-blind randomized trial).
A minimal total of 125 alcohol dependent subjects.
The experimental group and one of the two control groups will receive working memory training for 25 consecutive days.
Main study parameters/endpoints:
The difference in working memory performance, automatic preferences for alcohol, alcohol cravings, executive functioning, relapse rate and
alcohol use between patients who will receive working memory training and patients who will not receive working memory training.
Nature and extent of the burden and risks associated with participation, benefit and
Working memory training is an intervention that is used to strengthen executive functions. It is found that working memory training is highly relevant for reducing
clinical symptoms and to improve working memory capacity and other cognitive abilities in a variety of clinical samples. The study holds no direct risks for the participants.
|- Main changes (audit trail)|
|- RECORD||8-nov-2011 - 29-mei-2013|
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