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

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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Dependence
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: University of Amsterdam; PZ Heilig Hart; PZ Sint-Camillus
• Investigators: Principal Investigator: sarah C herremans, PhD, MD, UZ Gent

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: relapse; approach avoidance training; attentional bias training; alcohol depencence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: EC/2017/1079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No