Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT03601793
Status:
COMPLETED
Last Update Posted:
2019-06-25
First Post:
2018-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-24', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-07-25', 'lastUpdatePostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drinks preceding week', 'timeFrame': '3 and 6 months', 'description': 'Change in the number of standard drinks consumed during preceding week from baseline'}, {'measure': 'Heavy drinking days preceding week', 'timeFrame': '3 and 6 months', 'description': 'Change in the number of heavy drinking days during preceding week from baseline'}], 'secondaryOutcomes': [{'measure': 'Alcohol Use Disorders Identification Test (AUDIT)', 'timeFrame': 'Baseline, 3 month follow up, 6 month follow up', 'description': 'Assessment of alcohol problems'}, {'measure': 'Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)', 'timeFrame': 'Baseline, 3 month follow up, 6 month follow up', 'description': 'Assessment of alcohol consumption (the first 3 items in AUDIT)'}, {'measure': 'EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L)', 'timeFrame': 'Baseline, 3 month follow up, 6 month follow up', 'description': "Instrument measuring five health-related quality of life dimensions. Each dimension has five levels ranging from no problems to extreme problems. The dimensions can be combined into an index value between 0 (lowest) and 1 (highest). In addition to the five dimensions, a visual analogue scale item allows participants to measure health outcomes that reflect the participant's judgement. Endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0)."}, {'measure': 'DSM criteria', 'timeFrame': 'Baseline', 'description': 'The 11 DSM criteria of alcohol use disorders (yes/no)'}, {'measure': 'Previously received treatment or help for alcohol concerns', 'timeFrame': 'Baseline (treatment or help ever/in the past 12 months), 3 month follow up (treatment or help in the past 3 months), 6 month follow up (treatment or help in the past 3 months)', 'description': 'Questions about what kind of treatment or help for alcohol concerns the participant has received previously'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Problem']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.camh.ca/en/research', 'label': "Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an internet intervention for alcohol problems is more effective when delivered with assistance from a health care educator via e-mail during the first two weeks after randomization, as compared to simply providing the intervention without any such assistance.', 'detailedDescription': "This project aims to study the previously evaluated multi-module internet intervention Alcohol Help Center delivered with assistance from a health educator (AHC+A). The assistance will be in the form of email contact with the participant during the first two weeks after randomization. AHC+A will be tested against a group receiving access to the intervention without any such assistance (AHC).\n\nThe Investigators hypothesize that\n\n1. participants allocated to AHC+A will display significant reductions in drinking (drinks preceding week/heavy drinking days preceding week) in 3- and 6-month follow ups compared to AHC\n2. participants allocated to AHC+A will display greater engagement with the intervention in terms of a higher number of modules completed compared to AHC\n3. engagement with the intervention will mediate any effects on drinking behavior.\n\nA 2-arm parallel group randomized controlled trial will be used to test these specified hypotheses. Follow-ups will be conducted at 3 and 6 months after randomization. Online media advertisements will be used to recruit people with current alcohol problems, and will target people who are 'experiencing difficulties in controlling or cutting down on their drinking.' The advertisements will be placed across Canada using locations found successful in previous trials to rapidly recruit participants (e.g. Google AdWords)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A score of 8 or more on the Alcohol Use Disorder Identification Test (AUDIT)\n* A preceding week alcohol consumption of 14 standard drinks or more\n\nExclusion Criteria:\n\n* Being under 18 years of age'}, 'identificationModule': {'nctId': 'NCT03601793', 'briefTitle': 'An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'Using Assistance From a Health Educator to Increase Effectiveness of an Internet Intervention for Alcohol Problems. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '029/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet intervention with assistance', 'description': 'This arm is given access to the internet intervention Alcohol Help Center with email assistance from a health educator during the first two weeks after randomization.', 'interventionNames': ['Behavioral: Alcohol Help Center', 'Behavioral: Assistance from a health educator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Internet intervention without assistance', 'description': 'This arm is given access to the internet intervention Alcohol Help Center without any assistance from a health educator.', 'interventionNames': ['Behavioral: Alcohol Help Center']}], 'interventions': [{'name': 'Alcohol Help Center', 'type': 'BEHAVIORAL', 'description': 'An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems', 'armGroupLabels': ['Internet intervention with assistance', 'Internet intervention without assistance']}, {'name': 'Assistance from a health educator', 'type': 'BEHAVIORAL', 'description': 'This entails email contact with a health educator that guides the participant through the Alcohol Help Center during the first two weeks', 'armGroupLabels': ['Internet intervention with assistance']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 2S1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'John A Cunningham, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'John Cunningham', 'investigatorAffiliation': 'Centre for Addiction and Mental Health'}}}}