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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338361
• Other study ID #: EC/2017/1079
• Status: Completed
• Phase: N/A
• Start date: October 26, 2017
• Est. completion date: February 29, 2020

Study information

• Verified date: December 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• active approach avoidance training and sham visual probe training
patients receive active AAT training and sham VPT training
• sham approach avoidance training and active visual probe training
patients receive sham AAT training and active VPT training
• active approach avoidance training and active visual probe training
patients receive active AAT training and active VPT training
• sham approach avoidance training and sham visual probe training
patients receive sham AAT training and sham VPT training

Locations

Country	Name	City	State
Belgium	University Ghent	Ghent

Sponsors (4)

Lead Sponsor	Collaborator
University Ghent	PZ Heilig Hart, PZ Sint-Camillus, University of Amsterdam

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in drinking behavior	score of AUDIT-c (first 3 questions of the AUDIT)	baseline; At 3 months post-training: change in audit-c score at baseline and 3 months post training
Other	Time to first drink	Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage	assessed at 3 months post-training
Other	Time to first drink	Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage	assessed at 6 months post-training
Other	Time to first drink	Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage	assessed at 1 year post-training
Other	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	assessed at 3 months post-training
Other	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	assessed at 6 monthspost-training
Other	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	assessed at 1 year post-training
Primary	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	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
Secondary	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