Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 2:57 PM
Study NCT ID:
NCT07373405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-28
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Interventions to Prevent Alcohol Use Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3519}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2038-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-19', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantity-Frequency-Variability Index', 'timeFrame': 'From enrollment to 24 months.', 'description': 'Alcohol consumption will be assessed using the Quantity-Frequency-Variability index, a quantity-frequency measure capturing drinking patterns over the past 7 and 30 days. The Quantity-Frequency-Variability index provides estimates of the number of drinking days, the number of drinks per drinking day, and the number of heavy drinking days (≥ 5 standard units of alcohol \\[SUA\\]). These measures are listed separately as distinct primary outcome measures.'}, {'measure': 'Quantity-Frequency-Variability Index: Alcohol Frequency', 'timeFrame': 'From enrollment to 24 months.', 'description': 'Measured using the Quantity-Frequency-Variability Index. Participants report the number of days they consumed alcohol in the past 7 and 30 days. Higher values indicate more frequent drinking.'}, {'measure': 'Quantity-Frequency-Variability Index: Alcohol Quantity', 'timeFrame': 'From enrollment to 24 months.', 'description': 'Measured using the Quantity-Frequency-Variability Index. Participants report the average number of standard units of alcohol (SUA) consumed on a typical drinking day in the past 30 days. Higher values indicate higher consumption per occasion.'}, {'measure': 'Quantity-Frequency-Variability Index: Alcohol Variability', 'timeFrame': 'From enrollment to 24 months.', 'description': 'Measured using the Quantity-Frequency-Variability Index. Participants report the number of days they consumed ≥ 5 standard units of alcohol (SUA) in the past 7 and 30 days. This captures the variability and pattern of drinking.'}], 'secondaryOutcomes': [{'measure': 'Client Satisfaction Questionnaire Adapted to Internet-Based Interventions', 'timeFrame': 'Assessed at the 3-month follow-up assessment.', 'description': 'The Client Satisfaction Questionnaire Adapted to Internet-Based Interventions includes 8 items measuring global satisfaction with web-based interventions. Each item is rated on a 4-point Likert scale ranging from 1 (does not apply to me) to 4 (does totally apply to me). The minimum score is 8 and the maximum score is 32. Higher scores indicate higher satisfaction.'}, {'measure': 'System Usability Scale', 'timeFrame': 'Assessed at the 3-month follow-up assessment.', 'description': 'The 10-item System Usability Scale will be used to measure subjective usability of internet-based interventions. The items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The minimum score is 0 and the maximum score is 100. Higher scores indicate better usability.'}, {'measure': 'Readiness-to-Change Questionnaire - Treatment Version', 'timeFrame': 'Assessed at baseline and at 3, 6, 12, and 24 months follow-up.', 'description': "The Readiness-to-Change Questionnaire - Treatment Version is a 12-item measure designed to assess the respondent's stated intentions regarding changing their drinking behaviour. It includes three subscales representing different stages of change: (1) Pre-contemplation, (2) Contemplation, and (3) Action. Each subscale consists of four items, and responses are rated on a 5-point Likert Scale ranging from -2 (strongly disagree) to +2 (strongly agree). Total scores can range from -24 to +24. Higher scores on a specific subscale indicate greater alignment with that stage of change."}, {'measure': 'Alcohol Use Disorders Identification Test', 'timeFrame': 'Assessed at baseline and at 3, 6, 12, and 24 months follow-up.', 'description': 'The Alcohol Use Disorders Identification Test consists of 10 items assessing alcohol consumption, drinking behaviours, and alcohol-related problems. Items 1 to 8 are scored 0, 1, 2, 3 or 4, while items 9 and 10 are scored 0, 2 or 4. The total score can range from 0 to 40, with 0 indicating an abstainer who has never experienced any alcohol-related problems. In the study, only individuals who score ≥8 for men and ≥6 for women will be included, as scores from 1 to 7 for men and 1 to 5 for women suggest low-risk alcohol consumption according to WHO guidelines. Scores of 8 to 15 for men and 6 to 13 for women indicate hazardous or harmful alcohol consumption, while scores above 15 for men and above 13 for women suggest the likelihood of alcohol dependence (moderate-severe alcohol use disorder).'}, {'measure': 'Drug Use Disorders Identification Test', 'timeFrame': 'Assessed at baseline and at 3, 6, 12, and 24 months follow-up.', 'description': 'The Drug Use Disorders Identification Test consists of 11 items assessing drug use patterns and drug-related problems (excluding alcohol). Items 1 to 9 are scored 0, 1, 2, 3 or 4, while items 10 and 11 and are scored 0, 2 or 4. The total possible score ranges from 0 to 44, with higher scores reflecting higher drug dependence. A score of 6 for men and 2 for women indicates drug-related problems or harmful drug consumption, while a score of greater than 24 for both sexes suggests probable dependence on one or more drugs.'}, {'measure': 'EuroQol five-dimensions-five-levels: Index Value', 'timeFrame': 'Assessed at baseline and at 3, 6, 12, and 24 months follow-up.', 'description': 'The EuroQol five-dimensions-five-levels assesses quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels of severity for each (no problems, slight problems, moderate problems, severe problems, or extreme problems). The health state profile is converted into a single index value using the Danish value set (Jensen et al., 2023). In this context, the maximum score is 1.0, while the minimum score is -0.757. Higher scores indicates higher quality of life.'}, {'measure': 'EuroQol five-dimensions-five-levels: Visual Analogue Scale', 'timeFrame': 'Assessed at baseline and at 3, 6, 12, and 24 months follow-up.', 'description': 'Participants rate their overall health on a vertical visual analogue scale. The scales ranges from 0 to 100. Higher scores indicate greater overall health perception.'}, {'measure': 'Brief Symptom Inventory 18', 'timeFrame': 'Assessed at baseline and at 3, 6, 12, and 24 months follow-up.', 'description': 'The Brief Symptom Inventory 18 is an 18-item questionnaire designed to assess psychological distress. Each item describes a symptom, and respondents rate the extent to which they have been bothered by the symptom over the past week on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). Scores for all items are summarized on the Global Severity Index. The minimum score is 0 and the maximum score is 72. Higher scores indicate higher levels of psychological distress.'}, {'measure': 'Buss-Perry Aggression Questionnaire - Short-Form', 'timeFrame': 'Assessed at baseline and at 3, 6, 12, and 24 months follow-up.', 'description': 'The 12-item Buss-Perry Aggression Questionnaire - Short-Form consists of four subscales measuring hostility, anger, and physical and verbal aggression. Each subscale consists of three items, and responses are rated on a 5-point Likert scale ranging from 1 (extremely unlike me) to 5 (extremely like me). The minimum score is 12 and the maximum score is 60. Higher scores indicate higher levels of aggression.'}, {'measure': 'Negative Effects Questionnaire', 'timeFrame': 'Assessed at the 3-month follow-up assessment.', 'description': 'The Negative Effects Questionnaire includes 20 items rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely), distinguishing between negative effects attributed to the intervention and those potentially caused by other factors. The minimum score is 0 and the maximum score is 80. Higher scores indicate a higher burden of negative effects.'}, {'measure': 'Register Data: Danish Education and Income Statistics Registers', 'timeFrame': 'Will be collected for 10 years from enrollment.', 'description': 'Information on highest achieved education, employment, and economy will be retrieved.'}, {'measure': 'Register Data: Danish National Patient Register', 'timeFrame': 'Will be collected for 10 years from enrollment.', 'description': 'Data on inpatient and outpatient Alcohol Use Disorder-related contacts, prior Alcohol Use Disorder treatment, and other comorbidities will be collected.'}, {'measure': 'Register Data: National Alcohol Treatment Register', 'timeFrame': 'Will be collected for 10 years from enrollment.', 'description': 'Data on Alcohol Use Disorder treatment duration and intensity, treatment retention and type of treatment conclusion (i.e., dropout or completion), and prior Alcohol Use Disorder treatment will be retrieved.'}, {'measure': 'Register Data: National Register of Substance Abusers in treatment', 'timeFrame': 'Will be collected for 10 years from enrollment.', 'description': 'Data on Alcohol Use Disorder treatment duration and intensity, treatment retention and type of treatment conclusion (i.e., dropout or completion), and prior Alcohol Use Disorder treatment will be retrieved.'}, {'measure': 'Register Data: Danish Prescription Register', 'timeFrame': 'Will be collected for 10 years from enrollment.', 'description': 'Data on prescription of pharmacological treatment targeting Alcohol Use Disorder (e.g. disulfiram, naltrexone) and number of released receipts will be retrieved.'}, {'measure': 'Register Data: Psychiatric Central Research Register', 'timeFrame': 'Will be collected for 10 years from enrollment.', 'description': 'Data on inpatient and outpatient Alcohol Use Disorder-related contacts, prior Alcohol Use Disorder treatment, and other comorbidities will be collected.'}, {'measure': 'Register Data: Cause of Death Register', 'timeFrame': 'Will be collected for 10 years from enrollment.', 'description': 'Data on the date and primary cause of death, including both internal and external causes (accident, suicide, or murder), will be retrieved.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcohol Use Disorder', 'Internet-Based Interventions', 'Machine Learning', 'Non-treatment Seekers', 'Stepped-Care'], 'conditions': ['Alcohol Use Disorder (AUD)']}, 'descriptionModule': {'briefSummary': 'Background: Internet-based interventions can improve access to non-treatment-seeking populations, preventing the onset or progression of alcohol use disorder (AUD). Stepped-care guidelines for face-to-face AUD interventions recommend internet-based Brief Intervention (iBI) or unguided Cognitive Behavioural Therapy (iCBT) for no or mild AUD, and guided iCBT for moderate to severe AUD. However, no large-scale superiority trial has compared the effectiveness of these interventions among non-treatment-seeking individuals across the full spectrum of problematic alcohol use.\n\nAims: 1) Compare the effectiveness of iBI, unguided, and guided iCBT in reducing alcohol consumption in non-treatment-seeking individuals with sub-threshold or full AUD; 2) develop models via machine learning for personalized AUD prevention and progression management.\n\nMethods: A nationwide sample of 3519 individuals will be stratified by sub-threshold/mild AUD and moderate/severe AUD and randomized to: 1) online assessment (OA)+ iBI; 2) OA+ unguided iCBT; or 3) OA+ guided iCBT. The iCBT sessions will address problematic alcohol use and co-occuring externalizing and internalizing psychiatric symptoms. Data will be collected from OA, interventions, and Danish registries at baseline and 3-, 6-, 12-, and 24-month follow-ups, with registry follow-up over 10 years.\n\nPerspectives: Findings will compare stepped-care and machine learning-driven personalized approaches to inform guidelines for non-treatment-seeking populations. Internet-based assessment and interventions support continuous data collection, enabling ongoing improvements and personalized prevention. This large-scale dissemination targeting non-treatment-seeking populations across the full spectrum of problematic alcohol use will pave the way for future initiatives and may refine prevention strategies if the stepped-care model proves insufficient for this group.\n\nKey words: Alcohol Use Disorder, Internet-Based Interventions, Machine Learning, Non-treatment Seekers, Stepped-Care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signing written informed consent\n* Being aged ≥ 18 years\n* Being a Danish resident and fluent in Danish\n* Having at least weekly access to a computer or mobile phone with internet\n* Having at least hazardous alcohol use, corresponding to an AUDIT cut-off score of ≥ 8/6 for men/women (no upper limit on the AUDIT score, as the alternative is no preventive intervention)\n\nExclusion Criteria:\n\n* Receiving other psychological treatment\n* Being suicidal or having severe comorbid psychiatric disorders (e.g., psychotic disorders).'}, 'identificationModule': {'nctId': 'NCT07373405', 'briefTitle': 'Online Interventions to Prevent Alcohol Use Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Internet-based Interventions to Prevent the Development and Progression of Alcohol Use Disorders With and Without Internalizing and Externalizing Symptoms in Non-treatment Seekers: Protocol for a Nationwide Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'S-20250010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Internet-Based Brief Alcohol Intervention', 'interventionNames': ['Behavioral: Internet-Based Brief Alcohol Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Unguided Internet-Based Cognitive Behavioral Therapy', 'interventionNames': ['Behavioral: Unguided Internet-Based Cognitive Behavioral Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Guided Internet-Based Cognitive Behavioral Therapy', 'interventionNames': ['Behavioral: Guided Internet-Based Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'Internet-Based Brief Alcohol Intervention', 'type': 'BEHAVIORAL', 'description': 'Brief Alcohol Intervention usually involves two components: assessing for hazardous alcohol use or AUD to identify problems early, and providing counselling. We are testing the effects of a digitalized version.', 'armGroupLabels': ['Internet-Based Brief Alcohol Intervention']}, {'name': 'Unguided Internet-Based Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'Unguided Internet-based Cognitive Behavioral Therapy (iCBT) is a cost-effective intervention, where users complete structured, evidence-based CBT modules online without therapist involvement. The programs focus on teaching users techniques like identifying and challenging negative thoughts to manage - in this context - Alcohol Use Disorder symptoms.', 'armGroupLabels': ['Unguided Internet-Based Cognitive Behavioral Therapy']}, {'name': 'Guided Internet-Based Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'Guided Internet-Based Cognitive Behavioral Therapy (iCBT) utilizes the structured, online delivery of CBT modules but adds regular, personalized support from a human therapist or trained coach. This human component typically involves checking assignments, providing motivational feedback, and tailoring advice to significantly boost user adherence and clinical outcomes.', 'armGroupLabels': ['Guided Internet-Based Cognitive Behavioral Therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Angelina Isabella Mellentin, Ph.D.', 'role': 'CONTACT', 'email': 'amellentin@health.sdu.dk', 'phone': '+45 65 41 13 31'}, {'name': 'Nicolai Nør-Hansen, Pregraduate Psychology student', 'role': 'CONTACT', 'email': 'nnoer21@student.sdu.dk', 'phone': '+45 21 48 58 75'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}