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Completed

NCT Number: NCT03338361

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

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active approach avoidance training and sham visual probe training

Behavioral

patients receive active AAT training and sham VPT training

sham approach avoidance training and active visual probe training

Behavioral

patients receive sham AAT training and active VPT training

active approach avoidance training and active visual probe training

Behavioral

patients receive active AAT training and active VPT training

sham approach avoidance training and sham visual probe training

Behavioral

patients receive sham AAT training and sham VPT training

Primary outcomes

  1. change in drink behavior

    Time frame: 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 outcomes

  1. change in Retraining attentional bias

    Time frame: baseline and between 1 and 7 days after completion of the 6 training sessions: change

    The effect on a VPT task

  2. change in Retraining action tendencies

    Time frame: baseline and between 1 and 7 days after completion of the 6 training sessions: change in action tendencies

    The effect on a AAT task

Other outcomes

  1. change in drinking behavior

    Time frame: baseline; At 3 months post-training: change in audit-c score at baseline and 3 months post training

    score of AUDIT-c (first 3 questions of the AUDIT)

  2. Time to first drink

    Time frame: assessed at 3 months post-training

    Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage

  3. Time to first drink

    Time frame: assessed at 6 months post-training

    Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage

  4. Time to first drink

    Time frame: assessed at 1 year post-training

    Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage

  5. Time to first heavy drinking day

    Time frame: assessed at 3 months post-training

    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

  6. Time to first heavy drinking day

    Time frame: assessed at 6 monthspost-training

    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

  7. Time to first heavy drinking day

    Time frame: assessed at 1 year post-training

    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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • PZ Heilig Hart
  • PZ Sint-Camillus
  • University of Amsterdam

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2017
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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