Online Interventions to Prevent Alcohol Use Disorders

NCT07373405 | Not Yet Recruiting

• 1 other identifier: S-20250010
• Study Type: interventional
• Target: 3,519
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. Aims: 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. Methods: 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. Perspectives: 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. Key words: Alcohol Use Disorder, Internet-Based Interventions, Machine Learning, Non-treatment Seekers, Stepped-Care

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol Use Disorder; Internet-Based Interventions; Machine Learning; Non-treatment Seekers; Stepped-Care

Outcome Measures

Primary Outcomes (4)

• Quantity-Frequency-Variability Index

  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.

  From enrollment to 24 months.

• Quantity-Frequency-Variability Index: Alcohol Frequency

  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.

  From enrollment to 24 months.

• Quantity-Frequency-Variability Index: Alcohol Quantity

  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.

  From enrollment to 24 months.

• Quantity-Frequency-Variability Index: Alcohol Variability

  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.

  From enrollment to 24 months.

Secondary Outcomes (17)

• Client Satisfaction Questionnaire Adapted to Internet-Based Interventions

  Assessed at the 3-month follow-up assessment.

• System Usability Scale

  Assessed at the 3-month follow-up assessment.

• Readiness-to-Change Questionnaire - Treatment Version

  Assessed at baseline and at 3, 6, 12, and 24 months follow-up.

• Alcohol Use Disorders Identification Test

  Assessed at baseline and at 3, 6, 12, and 24 months follow-up.

• Drug Use Disorders Identification Test

  Assessed at baseline and at 3, 6, 12, and 24 months follow-up.

Study Arms (3)

Internet-Based Brief Alcohol Intervention

ACTIVE COMPARATOR

Behavioral: Internet-Based Brief Alcohol Intervention

Unguided Internet-Based Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Behavioral: Unguided Internet-Based Cognitive Behavioral Therapy

Guided Internet-Based Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Behavioral: Guided Internet-Based Cognitive Behavioral Therapy

Interventions

Internet-Based Brief Alcohol Intervention BEHAVIORAL

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.

Internet-Based Brief Alcohol Intervention

Unguided Internet-Based Cognitive Behavioral Therapy BEHAVIORAL

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.

Unguided Internet-Based Cognitive Behavioral Therapy

Guided Internet-Based Cognitive Behavioral Therapy BEHAVIORAL

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.

Guided Internet-Based Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing written informed consent
• Being aged ≥ 18 years
• Being a Danish resident and fluent in Danish
• Having at least weekly access to a computer or mobile phone with internet
• 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)

You may not qualify if:

• Receiving other psychological treatment
• Being suicidal or having severe comorbid psychiatric disorders (e.g., psychotic disorders).

Sponsors & Collaborators

• University of Southern Denmark: lead

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; Methods

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Central Study Contacts

Angelina Isabella Mellentin, Ph.D.

CONTACT

+45 65 41 13 31; amellentin@health.sdu.dk

Nicolai Nør-Hansen, Pregraduate Psychology student

CONTACT

+45 21 48 58 75; nnoer21@student.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 28, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2038
• Last Updated: January 28, 2026

Record last verified: 2026-01