Research on the Efficacy of the T.O.P. Computer Training Procedure in the Treatment of Alcohol Dependence

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Approach Avoidance and Attentional Bias Retraining in Alcohol-dependent Patients: a Randomized Controlled Trial in a Clinical Setting

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Behavioral: active approach avoidance training and sham visual probe training
* Behavioral: sham approach avoidance training and active visual probe training
* Behavioral: active approach avoidance training and active visual probe training
* Behavioral: sham approach avoidance training and sham visual probe training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hospitalized alcohol-dependent patients, choosing for abstinence en committed to treatment detoxification (with benzodiazepines) is terminated Dutch speaking Exclusion Criteria: neurological condition, such as Korsakoff syndrome cognitive problems (cut-off <26/30 on the Montral Cognitive Assessment) psychotic disorders visual and motor problems at the hands non-Dutch speaking mental retardation patients who are illiterate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AAT active - VPT sham<br>Approach avoidance training active intervention and visual probe training sham intervention | Behavioral: active approach avoidance training and sham visual probe training<br>* patients receive active AAT training and sham VPT training<br>|
| Experimental: VPT active - AAT sham<br>Visual probe training active condition and approach avoidance training sham condition | Behavioral: sham approach avoidance training and active visual probe training<br>* patients receive sham AAT training and active VPT training<br>|
| Experimental: AAT active - VPT active<br>Approach avoidance training active condition and visual probe training active condition | Behavioral: active approach avoidance training and active visual probe training<br>* patients receive active AAT training and active VPT training<br>|
| Sham Comparator: AAT sham - VPT sham<br>Approach avoidance training sham condition and visual probe training sham condition | Behavioral: sham approach avoidance training and sham visual probe training<br>* patients receive sham AAT training and sham VPT training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in drink behavior | AUDIT score | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Retraining attentional bias | The effect on a VPT task | 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 | baseline and between 1 and 7 days after completion of the 6 training sessions: change in action tendencies | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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approach avoidance training, attentional bias training, alcohol depencence, relapse