Clinical trial NCT03338361: Research on the Efficacy of the "T.O.P. Computer Training" Procedure in the Treatment of Alcohol Dependence
Official title: Efficacy of Approach Avoidance and Attentional Bias Retraining in Alcohol-dependent Patients: a Randomized Controlled Trial in a Clinical Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Keywords: approach avoidance training
attentional bias training
alcohol depencence
relapse
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: PZ Heilig Hart
name: PZ Sint-Camillus
name: University of Amsterdam
First posted: 2017-11-09
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in drink behavior
timeFrame: 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 outcomes:
measure: change in Retraining attentional bias
timeFrame: baseline and between 1 and 7 days after completion of the 6 training sessions: change
measure: change in Retraining action tendencies
timeFrame: baseline and between 1 and 7 days after completion of the 6 training sessions: change in action tendencies
Other outcomes:
measure: change in drinking behavior
timeFrame: baseline; At 3 months post-training: change in audit-c score at baseline and 3 months post training
measure: Time to first drink
timeFrame: assessed at 3 months post-training
measure: Time to first drink
timeFrame: assessed at 6 months post-training
measure: Time to first drink
timeFrame: assessed at 1 year post-training
measure: Time to first heavy drinking day
timeFrame: assessed at 3 months post-training
measure: Time to first heavy drinking day
timeFrame: assessed at 6 monthspost-training
measure: Time to first heavy drinking day
timeFrame: assessed at 1 year post-training
Locations:
city: Ghent
country: Belgium
facility: University Ghent
Study officials:
affiliation: UZ Gent
name: sarah C herremans, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: