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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03338361
Enrollment
247
Registered
2017-11-09
Start date
2017-10-26
Completion date
2020-02-29
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence

Keywords

approach avoidance training, attentional bias training, alcohol depencence, relapse

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.

Interventions

BEHAVIORALactive approach avoidance training and sham visual probe training

patients receive active AAT training and sham VPT training

BEHAVIORALsham approach avoidance training and active visual probe training

patients receive sham AAT training and active VPT training

BEHAVIORALactive approach avoidance training and active visual probe training

patients receive active AAT training and active VPT training

BEHAVIORALsham approach avoidance training and sham visual probe training

patients receive sham AAT training and sham VPT training

Sponsors

PZ Heilig Hart
CollaboratorUNKNOWN
PZ Sint-Camillus
CollaboratorUNKNOWN
University of Amsterdam
CollaboratorOTHER
University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in drink behaviorbaseline, at 6 months and 1-year post training: change in auditscores between baseline, 6 months and 1-year post-training, and differences between groupsAUDIT score

Secondary

MeasureTime frameDescription
change in Retraining attentional biasbaseline and between 1 and 7 days after completion of the 6 training sessions: changeThe effect on a VPT task
change in Retraining action tendenciesbaseline and between 1 and 7 days after completion of the 6 training sessions: change in action tendenciesThe effect on a AAT task

Other

MeasureTime frameDescription
change in drinking behaviorbaseline; At 3 months post-training: change in audit-c score at baseline and 3 months post trainingscore of AUDIT-c (first 3 questions of the AUDIT)
Time to first drinkassessed at 3 months post-trainingTime it takes between finalization of the training and the day the patients drinks an alcoholic beverage
Time to first heavy drinking dayassessed at 3 months post-trainingTime 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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026