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

University Ghent

Status: Completed

Conditions: Alcohol Dependence

Treatments: Behavioral: sham 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: active approach avoidance training and sham visual probe training

Study type: Interventional

Funder types: Other

Identifiers

NCT03338361

EC/2017/1079

Details and patient eligibility

About

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.

Enrollment: 247 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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247 participants in 4 patient groups

AAT active - VPT sham

Experimental group

Description:

Approach avoidance training active intervention and visual probe training sham intervention

Treatment:

Behavioral: active approach avoidance training and sham visual probe training

VPT active - AAT sham

Experimental group

Description:

Visual probe training active condition and approach avoidance training sham condition

Treatment:

Behavioral: sham approach avoidance training and active visual probe training

AAT active - VPT active

Experimental group

Description:

Approach avoidance training active condition and visual probe training active condition

Treatment:

Behavioral: active approach avoidance training and active visual probe training

AAT sham - VPT sham

Sham Comparator group

Description:

Approach avoidance training sham condition and visual probe training sham condition

Treatment:

Behavioral: sham approach avoidance training and sham visual probe training