Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-31 @ 10:35 PM
Study NCT ID:
NCT03338361
Status:
COMPLETED
Last Update Posted:
2021-12-21
First Post:
2017-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on the Efficacy of the "T.O.P. Computer Training" Procedure in the Treatment of Alcohol Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-20', 'studyFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2017-11-06', 'lastUpdatePostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change in drinking behavior', 'timeFrame': 'baseline; At 3 months post-training: change in audit-c score at baseline and 3 months post training', 'description': 'score of AUDIT-c (first 3 questions of the AUDIT)'}, {'measure': 'Time to first drink', 'timeFrame': 'assessed at 3 months post-training', 'description': 'Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage'}, {'measure': 'Time to first drink', 'timeFrame': 'assessed at 6 months post-training', 'description': 'Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage'}, {'measure': 'Time to first drink', 'timeFrame': 'assessed at 1 year post-training', 'description': 'Time it takes between finalization of the training and the day the patients drinks an alcoholic beverage'}, {'measure': 'Time to first heavy drinking day', 'timeFrame': 'assessed at 3 months post-training', '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'}, {'measure': 'Time to first heavy drinking day', 'timeFrame': 'assessed at 6 monthspost-training', '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'}, {'measure': 'Time to first heavy drinking day', 'timeFrame': 'assessed at 1 year post-training', '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'}], 'primaryOutcomes': [{'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', 'description': 'AUDIT score'}], 'secondaryOutcomes': [{'measure': 'change in Retraining attentional bias', 'timeFrame': 'baseline and between 1 and 7 days after completion of the 6 training sessions: change', 'description': 'The effect on a VPT task'}, {'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', 'description': 'The effect on a AAT task'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['approach avoidance training', 'attentional bias training', 'alcohol depencence', 'relapse'], 'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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.\n\nOutcome 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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalized alcohol-dependent patients, choosing for abstinence en committed to treatment\n* detoxification (with benzodiazepines) is terminated\n* Dutch speaking\n\nExclusion Criteria:\n\n* neurological condition, such as Korsakoff syndrome\n* cognitive problems (cut-off \\<26/30 on the Montral Cognitive Assessment)\n* psychotic disorders\n* visual and motor problems at the hands\n* non-Dutch speaking\n* mental retardation\n* patients who are illiterate'}, 'identificationModule': {'nctId': 'NCT03338361', 'briefTitle': 'Research on the Efficacy of the "T.O.P. Computer Training" Procedure in the Treatment of Alcohol Dependence', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Efficacy of Approach Avoidance and Attentional Bias Retraining in Alcohol-dependent Patients: a Randomized Controlled Trial in a Clinical Setting', 'orgStudyIdInfo': {'id': 'EC/2017/1079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AAT active - VPT sham', 'description': 'Approach avoidance training active intervention and visual probe training sham intervention', 'interventionNames': ['Behavioral: active approach avoidance training and sham visual probe training']}, {'type': 'EXPERIMENTAL', 'label': 'VPT active - AAT sham', 'description': 'Visual probe training active condition and approach avoidance training sham condition', 'interventionNames': ['Behavioral: sham approach avoidance training and active visual probe training']}, {'type': 'EXPERIMENTAL', 'label': 'AAT active - VPT active', 'description': 'Approach avoidance training active condition and visual probe training active condition', 'interventionNames': ['Behavioral: active approach avoidance training and active visual probe training']}, {'type': 'SHAM_COMPARATOR', 'label': 'AAT sham - VPT sham', 'description': 'Approach avoidance training sham condition and visual probe training sham condition', 'interventionNames': ['Behavioral: sham approach avoidance training and sham visual probe training']}], 'interventions': [{'name': 'active approach avoidance training and sham visual probe training', 'type': 'BEHAVIORAL', 'description': 'patients receive active AAT training and sham VPT training', 'armGroupLabels': ['AAT active - VPT sham']}, {'name': 'sham approach avoidance training and active visual probe training', 'type': 'BEHAVIORAL', 'description': 'patients receive sham AAT training and active VPT training', 'armGroupLabels': ['VPT active - AAT sham']}, {'name': 'active approach avoidance training and active visual probe training', 'type': 'BEHAVIORAL', 'description': 'patients receive active AAT training and active VPT training', 'armGroupLabels': ['AAT active - VPT active']}, {'name': 'sham approach avoidance training and sham visual probe training', 'type': 'BEHAVIORAL', 'description': 'patients receive sham AAT training and sham VPT training', 'armGroupLabels': ['AAT sham - VPT sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'sarah C herremans, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Gent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'PZ Heilig Hart', 'class': 'UNKNOWN'}, {'name': 'PZ Sint-Camillus', 'class': 'UNKNOWN'}, {'name': 'University of Amsterdam', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}