NCT07373405

Online Interventions to Prevent Alcohol Use Disorders

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,519 (estimated)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
BEHAVIORAL	Internet-Based Brief Alcohol Intervention	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.
BEHAVIORAL	Unguided Internet-Based Cognitive Behavioral Therapy	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.
BEHAVIORAL	Guided Internet-Based Cognitive Behavioral Therapy	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-12-01
• Completion: 2038-12-01
• First posted: 2026-01-28
• Last updated: 2026-01-28