Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT05767567
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2023-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers
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': 867}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2023-03-02', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of drinks consumed during a typical week', 'timeFrame': 'Three months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Consumption']}, 'descriptionModule': {'briefSummary': "Unhealthy alcohol consumption is common in the UK and causes tremendous harm to the individual, as well as harm to others. A significant gap in providing alcohol support is that most people with unhealthy alcohol consumption will never receive advice to cut down on their drinking. However, many are interested in self-directed interventions to help them evaluate their drinking and to motivate reductions in alcohol use. One such promising intervention uses online personalised normative feedback (PNF) which compares a person's drinking with others in the general population of the same age and sex. PNF interventions are thought to work because many people with unhealthy alcohol consumption overestimate how much others drink. Multiple trials have demonstrated that providing PNF to people with unhealthy consumption reduces their alcohol use . While several UK websites do provide feedback on assessment of risk (e.g., Down Your Drink introductory section, Alcohol Change UK), there appears to be no online intervention that provides PNF for unhealthy alcohol consumption.\n\nThe major objective of this pilot project is to conduct a two-arm, parallel group randomised controlled trial (RCT) in which 1,318 participants recruited from the Prolific website who have identified themselves as drinking 14 or more units per week are randomly assigned to one of two groups - a) those who are offered a PNF report, and b) those in a no intervention comparator group. Participants in the comparator group will not be provided any intervention materials but will instead be given a list of the different components of the PNF feedback and will be asked to think about how useful they would find each of them. Follow-up assessment will occur at 1 and 6 months post-randomisation. The project is described as a pilot because it is a preliminary evaluation of the PNF intervention in a UK context."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) score 8 or more on the AUDIT (indicating current unhealthy alcohol use); and 2) endorsed the attention check questions correctly.\n\nExclusion Criteria:\n\nNot meeting these inclusion criteria forms the exclusion criteria'}, 'identificationModule': {'nctId': 'NCT05767567', 'briefTitle': 'Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers', 'orgStudyIdInfo': {'id': 'HR-22/23-34937'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief 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: Brief Check Your Drinking (CYD)']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Brief Check Your Drinking (CYD)', 'type': 'BEHAVIORAL', 'description': 'The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking', 'armGroupLabels': ['Brief Check Your Drinking (CYD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC2R 2LS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Available from the PI upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}