Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT03060135
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2017-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 878}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2017-02-17', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the variable, number of drinks in a typical week, from baseline measurement to 6-month follow-up', 'timeFrame': '6 months', 'description': 'Sum of number of drinks consumed in a typical week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Consumption']}, 'referencesModule': {'references': [{'pmid': '32040383', 'type': 'DERIVED', 'citation': 'Schell C, Godinho A, Cunningham JA. To thine own self, be true: Examining change in self-reported alcohol measures over time as related to socially desirable responding bias among people with unhealthy alcohol use. Subst Abus. 2021;42(1):87-93. doi: 10.1080/08897077.2019.1697998. Epub 2020 Feb 10.'}, {'pmid': '31200648', 'type': 'DERIVED', 'citation': 'Cunningham JA, Godinho A, Bertholet N. Outcomes of two randomized controlled trials, employing participants recruited through Mechanical Turk, of Internet interventions targeting unhealthy alcohol use. BMC Med Res Methodol. 2019 Jun 14;19(1):124. doi: 10.1186/s12874-019-0770-4.'}], 'seeAlsoLinks': [{'url': 'http://www.camh.net/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': "There are a number of popular, freely available online interventions targeting hazardous alcohol consumption. Unfortunately, most have limited or no published evidence regarding their efficacy. Of particular interest is the intervention, 'Hello Sunday Morning.' The current project proposes to evaluate its' efficacy employing a RCT, using The Check Your Drinking intervention as an active comparator in the trial.\n\nParticipants will be recruited through Amazon's MTurk crowdsourcing platform. Potential participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 6 months time. Those who agree to be followed-up will be assigned by chance to be asked versus not asked to access one of the interventions and then recontacted 6 months later to ask about their drinking and their impressions of the online intervention. The primary hypothesis to be tested is that participants receiving access to any of the online interventions will report a greater level of reduction in number of drinks in a typical week between the baseline survey and six-month follow-up as compared to participants in the control condition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or over\n* A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)\n* Typically consumes 15 or more drinks per week,\n* Willingness to complete a 6-month follow-up survey\n\nExclusion Criteria: None'}, 'identificationModule': {'nctId': 'NCT03060135', 'briefTitle': 'Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '11/13/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Intervention: Control', 'description': 'A questionnaire that asks individuals what components of an online intervention they might find useful.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Check Your Drinking (CYD)', 'description': 'The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking', 'interventionNames': ['Behavioral: Check Your Drinking']}, {'type': 'EXPERIMENTAL', 'label': 'Hello Sunday Morning', 'description': 'Internet based program designed to assess drinking patterns, and support self-determined goals for abstinence, by providing users with an online platform and community to discuss progress and goals.', 'interventionNames': ['Behavioral: Hello Sunday Morning']}], 'interventions': [{'name': 'Check Your Drinking', 'type': 'BEHAVIORAL', 'description': "A anonymous brief survey designed to provide normative feedback of individual's drinking with the intent of motivating reductions in drinking", 'armGroupLabels': ['Check Your Drinking (CYD)']}, {'name': 'Hello Sunday Morning', 'type': 'BEHAVIORAL', 'description': "Brief online intervention that allows Individual's reflect on their drinking reductions progress and goals.", 'armGroupLabels': ['Hello Sunday Morning']}]}, '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, PhD', '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'}}}}