Research on the Efficacy of the "T.O.P. Computer Training" Procedure in the Treatment of Alcohol Dependence
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
active approach avoidance training and sham visual probe training
sham approach avoidance training and active visual probe training
active approach avoidance training and active visual probe training
sham approach avoidance training and sham visual probe training
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring approach avoidance training, attentional bias training, alcohol depencence, relapse
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
Sites / Locations
- University Ghent
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
AAT active - VPT sham
VPT active - AAT sham
AAT active - VPT active
AAT sham - VPT sham
Arm Description
Approach avoidance training active intervention and visual probe training sham intervention
Visual probe training active condition and approach avoidance training sham condition
Approach avoidance training active condition and visual probe training active condition
Approach avoidance training sham condition and visual probe training sham condition
Outcomes
Primary Outcome Measures
change in drink behavior
AUDIT score
Secondary Outcome Measures
change in Retraining attentional bias
The effect on a VPT task
change in Retraining action tendencies
The effect on a AAT task
Full Information
NCT ID
NCT03338361
First Posted
October 25, 2017
Last Updated
December 20, 2021
Sponsor
University Ghent
Collaborators
PZ Heilig Hart, PZ Sint-Camillus, University of Amsterdam
1. Study Identification
Unique Protocol Identification Number
NCT03338361
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
PZ Heilig Hart, PZ Sint-Camillus, University of Amsterdam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
approach avoidance training, attentional bias training, alcohol depencence, relapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
247 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AAT active - VPT sham
Arm Type
Experimental
Arm Description
Approach avoidance training active intervention and visual probe training sham intervention
Arm Title
VPT active - AAT sham
Arm Type
Experimental
Arm Description
Visual probe training active condition and approach avoidance training sham condition
Arm Title
AAT active - VPT active
Arm Type
Experimental
Arm Description
Approach avoidance training active condition and visual probe training active condition
Arm Title
AAT sham - VPT sham
Arm Type
Sham Comparator
Arm Description
Approach avoidance training sham condition and visual probe training sham condition
Intervention Type
Behavioral
Intervention Name(s)
active approach avoidance training and sham visual probe training
Intervention Description
patients receive active AAT training and sham VPT training
Intervention Type
Behavioral
Intervention Name(s)
sham approach avoidance training and active visual probe training
Intervention Description
patients receive sham AAT training and active VPT training
Intervention Type
Behavioral
Intervention Name(s)
active approach avoidance training and active visual probe training
Intervention Description
patients receive active AAT training and active VPT training
Intervention Type
Behavioral
Intervention Name(s)
sham approach avoidance training and sham visual probe training
Intervention Description
patients receive sham AAT training and sham VPT training
Primary Outcome Measure Information:
Title
change in drink behavior
Description
AUDIT score
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
Secondary Outcome Measure Information:
Title
change in Retraining attentional bias
Description
The effect on a VPT task
Time Frame
baseline and between 1 and 7 days after completion of the 6 training sessions: change
Title
change in Retraining action tendencies
Description
The effect on a AAT task
Time Frame
baseline and between 1 and 7 days after completion of the 6 training sessions: change in action tendencies
Other Pre-specified Outcome Measures:
Title
change in drinking behavior
Description
score of AUDIT-c (first 3 questions of the AUDIT)
Time Frame
baseline; At 3 months post-training: change in audit-c score at baseline and 3 months post training
Title
Time to first drink
Description
Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage
Time Frame
assessed at 3 months post-training
Title
Time to first drink
Description
Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage
Time Frame
assessed at 6 months post-training
Title
Time to first drink
Description
Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage
Time Frame
assessed at 1 year post-training
Title
Time to first heavy drinking day
Description
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
Time Frame
assessed at 3 months post-training
Title
Time to first heavy drinking day
Description
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
Time Frame
assessed at 6 monthspost-training
Title
Time to first heavy drinking day
Description
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
Time Frame
assessed at 1 year post-training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sarah C herremans, PhD, MD
Organizational Affiliation
UZ Gent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Research on the Efficacy of the "T.O.P. Computer Training" Procedure in the Treatment of Alcohol Dependence
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