An interventional study of active approach avoidance training and sham visual probe training and sham approach avoidance training and active visual probe training in Alcohol Dependence, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by University Ghent · Not applicable, Interventional, and Treatment
The investigators evaluate the efficacy of a computerised program (T.O.P. tool) consisting of an approach avoidance training (AAT) (to retrain action tendencies for alcohol-related stimuli), a visual probe training (VPT) (to retrain attentional bias for alcohol-related stimuli) and the combination of both training procedures versus placebo training, as an add-on to treatment as usual (psycho-education and cognitive behavioral therapy).
The investigators include hospitalized detoxified alcohol-dependent patients, who receive a four week training procedure, existing of a pre-assessment, 6 training sessions and a post-assessment.
Outcome measures consist of behavioral measures (consumption of alcohol - self report over 1 year), questionnaires (AUDIT; craving on 9-point likert scale) and approach avoidance and visual probe measurement tasks.
A six month and 1 year follow-up is included (behavioral measures and AUDIT). Further, the investigators will also assess credibility (9-point likert scale) of the training procedure before the start of the training and immediately after the assessment of the AAT and VPT training.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 247 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University Ghent is the lead sponsor of 350 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
Approach avoidance training active intervention and visual probe training sham intervention
Behavioral: active approach avoidance training and sham visual probe training
Visual probe training active condition and approach avoidance training sham condition
Behavioral: sham approach avoidance training and active visual probe training
Approach avoidance training active condition and visual probe training active condition
Behavioral: active approach avoidance training and active visual probe training
Approach avoidance training sham condition and visual probe training sham condition
Behavioral: sham approach avoidance training and sham visual probe training
patients receive active AAT training and sham VPT training
patients receive sham AAT training and active VPT training
patients receive active AAT training and active VPT training
patients receive sham AAT training and sham VPT training
change in drink behavior
AUDIT score
Time frame: baseline, at 6 months and 1-year post training: change in auditscores between baseline, 6 months and 1-year post-training, and differences between groups
change in Retraining attentional bias
The effect on a VPT task
Time frame: baseline and between 1 and 7 days after completion of the 6 training sessions: change
change in Retraining action tendencies
The effect on a AAT task
Time frame: baseline and between 1 and 7 days after completion of the 6 training sessions: change in action tendencies
change in drinking behavior
score of AUDIT-c (first 3 questions of the AUDIT)
Time frame: baseline; At 3 months post-training: change in audit-c score at baseline and 3 months post training
Time to first drink
Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage
Time frame: assessed at 3 months post-training
Time to first drink
Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage
Time frame: assessed at 6 months post-training
Time to first drink
Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage
Time frame: assessed at 1 year post-training
Time to first heavy drinking day
Time it takes between finalization of the training and the day a female patient drinks ≥ 4 alcoholic units/day and a male patient drinks ≥ 5 alcoholic units/day
Time frame: assessed at 3 months post-training
Time to first heavy drinking day
Time it takes between finalization of the training and the day a female patient drinks ≥ 4 alcoholic units/day and a male patient drinks ≥ 5 alcoholic units/day
Time frame: assessed at 6 monthspost-training
Time to first heavy drinking day
Time it takes between finalization of the training and the day a female patient drinks ≥ 4 alcoholic units/day and a male patient drinks ≥ 5 alcoholic units/day
Time frame: assessed at 1 year post-training
Plan to share: Undecided
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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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