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

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ClinicalTrials.gov Identifier: NCT03338361
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Collaborators:
PZ Heilig Hart
PZ Sint-Camillus
University of Amsterdam
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Alcohol Dependence Behavioral: active 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: sham approach avoidance training and sham visual probe training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Approach Avoidance and Attentional Bias Retraining in Alcohol-dependent Patients: a Randomized Controlled Trial in a Clinical Setting
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AAT active - VPT sham
Approach avoidance training active intervention and visual probe training sham intervention
Behavioral: active approach avoidance training and sham visual probe training
patients receive active AAT training and sham VPT training

Experimental: VPT active - AAT sham
Visual probe training active condition and approach avoidance training sham condition
Behavioral: sham approach avoidance training and active visual probe training
patients receive sham AAT training and active VPT training

Experimental: AAT active - VPT active
Approach avoidance training active condition and visual probe training active condition
Behavioral: active approach avoidance training and active visual probe training
patients receive active AAT training and active VPT training

Sham Comparator: AAT sham - VPT sham
Approach avoidance training sham condition and visual probe training sham condition
Behavioral: sham approach avoidance training and sham visual probe training
patients receive sham AAT training and sham VPT training




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338361


Contacts
Contact: Sarah C Herremans, PhD, MD +3293323762 sarah.herremans@uzgent.be

Locations
Belgium
University Ghent Recruiting
Ghent, Belgium, 9000
Contact: Sarah Herremans, MD, PhD    +3293323762    sarah.herremans@uzgent.be   
Sponsors and Collaborators
University Ghent
PZ Heilig Hart
PZ Sint-Camillus
University of Amsterdam
Investigators
Principal Investigator: sarah C herremans, PhD, MD UZ Gent

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03338361     History of Changes
Other Study ID Numbers: EC/2017/1079
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Ghent:
approach avoidance training
attentional bias training
alcohol depencence
relapse

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs