|- candidate number||22915|
|- NTR Number||NTR5503|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-sep-2015|
|- Secondary IDs||ERAB Grant - EA1442 AMC ethics number - NL49033.018.14|
|- Public Title||Training alcohol-related attentional biases in alcohol-dependence. What are the neurocognitive effects? |
|- Scientific Title||Training alcohol-related attentional biases in alcohol-dependence. What are the neurocognitive effects? |
|- ACRONYM||ABM - fMRI|
|- hypothesis||Training should affect attentional control processes specifically associated with alcohol-related stimuli. As a result, training as an additional treatment on top of CBT should reduce biases to alcohol-associated stimuli which have been linked with craving a relapse propensity. We expect that those individuals allocated to the training group should show reduced biases, also reflected as neuronal changes in the control of attention. Additionally the training should facilitate abstinence.|
|- Healt Condition(s) or Problem(s) studied||Alcohol dependence|
|- Inclusion criteria||• Male and female patients, aged between 18-70 years |
• Current DSM-V diagnosis of alcohol dependence
• Within the normal BMI range (18-30).
• Able to speak and understand Dutch.
• Able to speak and understand English.
|- Exclusion criteria||• Impairments in visual processing or in hand-eye coordination (this would make it difficult for patients to perform properly in the scanner)|
• Being on any anti-craving medication (baclofen, acamprosate, naltrexone, disulfiram, or topiramate)
• No previous or current abuse of drugs other than alcohol (excluding nicotine, cannabis and caffeine)
• Pregnancy, trying to conceive or breastfeeding.
• Having any metal implants, working or having worked with metal, teeth braces or bridges, tattoos above the shoulder, or cardiac pacemaker.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-okt-2015|
|- planned closingdate||31-dec-2016|
|- Target number of participants||60|
|- Interventions||Attentional bias modification training or active placebo will be given at random and double blind to a group of alcohol dependent outpatients from clinics recruited in and around Amsterdam.|
The real intervention is designed to train a person's ability to actively allocated attention to images of non-alcohol-containing beverages, while ignoring images of alcohol-containing drinks. thus the real training will involve training processes of attentional control in the presence of alcohol-associated images. On the other hand, the active placebo training condition will involve training attentional control processes more generally and not specific to alcohol-associated images.
All participants will receive a month of training, which is equivalent to 6 training sessions in total conducted over the internet.
|- Primary outcome||fMRI indices of attentional processing of alcohol-associated images will be taken both before and after the end of the training regimen. Changes in neural effects will be one outcome variable.
Changes in biases to alcohol-associated stimuli will also be investigated.
Propensity to relapse and number of drinks consumed and frequency of alcohol use in the month following the training
|- Secondary outcome||Propensity to relapse and number of drinks consumed and frequency of alcohol use in the month following the training|
|- Timepoints||Participants register on the trial
Undergo the baseline assessment session at Time point 1
Over the next 6 time-points, they undergo online training
Time point 8 will be the post-training assessment session
One month after Time point 8, they will will in a questionnaire with information about the drinking behaviour during the month after the training.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| |
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Psychiatry|
(Source(s) of Monetary or Material Support)
|ERAB grant EA1442|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||29-sep-2015 - 5-jan-2016|