Research on the Efficacy of the "T.O.P. Computer Training" Procedure in the Treatment of Alcohol Dependence
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AAT active - VPT sham Approach avoidance training active intervention and visual probe training sham intervention |
Behavioral: active approach avoidance training and sham visual probe training
patients receive active AAT training and sham VPT training
|
| Experimental: VPT active - AAT sham Visual probe training active condition and approach avoidance training sham condition |
Behavioral: sham approach avoidance training and active visual probe training
patients receive sham AAT training and active VPT training
|
| Experimental: AAT active - VPT active Approach avoidance training active condition and visual probe training active condition |
Behavioral: active approach avoidance training and active visual probe training
patients receive active AAT training and active VPT training
|
| Sham Comparator: AAT sham - VPT sham Approach avoidance training sham condition and visual probe training sham condition |
Behavioral: sham approach avoidance training and sham visual probe training
patients receive sham AAT training and sham VPT training
|
Outcome Measures
Primary Outcome Measures
- change in drink behavior [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]
AUDIT score
Secondary Outcome Measures
- change in Retraining attentional bias [baseline and between 1 and 7 days after completion of the 6 training sessions: change]
The effect on a VPT task
- change in Retraining action tendencies [baseline and between 1 and 7 days after completion of the 6 training sessions: change in action tendencies]
The effect on a AAT task
Other Outcome Measures
- change in drinking behavior [baseline; At 3 months post-training: change in audit-c score at baseline and 3 months post training]
score of AUDIT-c (first 3 questions of the AUDIT)
- Time to first drink [assessed at 3 months post-training]
Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage
- Time to first drink [assessed at 6 months post-training]
Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage
- Time to first drink [assessed at 1 year post-training]
Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage
- Time to first heavy drinking day [assessed at 3 months post-training]
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 to first heavy drinking day [assessed at 6 monthspost-training]
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 to first heavy drinking day [assessed at 1 year post-training]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
hospitalized alcohol-dependent patients, choosing for abstinence en committed to treatment
-
detoxification (with benzodiazepines) is terminated
-
Dutch speaking
Exclusion Criteria:
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neurological condition, such as Korsakoff syndrome
-
cognitive problems (cut-off <26/30 on the Montral Cognitive Assessment)
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psychotic disorders
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visual and motor problems at the hands
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non-Dutch speaking
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mental retardation
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patients who are illiterate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Ghent | Ghent | Belgium | 9000 |
Sponsors and Collaborators
- University Ghent
- PZ Heilig Hart
- PZ Sint-Camillus
- University of Amsterdam
Investigators
- Principal Investigator: sarah C herremans, PhD, MD, UZ Gent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EC/2017/1079