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

Not Applicable

Completed

• Conditions: Alcohol Dependence
• Interventions: Behavioral: sham approach avoidance training and active visual probe training; Behavioral: sham approach avoidance training and sham visual probe training; Behavioral: active approach avoidance training and sham visual probe training; Behavioral: active approach avoidance training and active visual probe training

• Registration Number: NCT03338361
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-25
• Study Start: 2017-10-26
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-09
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VPT active - AAT sham	sham approach avoidance training and active visual probe training	Visual probe training active condition and approach avoidance training sham condition
AAT sham - VPT sham	sham approach avoidance training and sham visual probe training	Approach avoidance training sham condition and visual probe training sham condition
AAT active - VPT sham	active approach avoidance training and sham visual probe training	Approach avoidance training active intervention and visual probe training sham intervention
AAT active - VPT active	active approach avoidance training and active visual probe training	Approach avoidance training active condition and visual probe training active condition

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

University Ghent; 🇧🇪 Ghent, Belgium