Online Interventions to Prevent Alcohol Use Disorders

University of Southern Denmark (SDU)

Status: Not yet enrolling

Conditions: Alcohol Use Disorder (AUD)

Treatments: Behavioral: Unguided Internet-Based Cognitive Behavioral Therapy; Behavioral: Internet-Based Brief Alcohol Intervention; Behavioral: Guided Internet-Based Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07373405

S-20250010

Details and patient eligibility

About

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

Enrollment: 3,519 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,519 participants in 3 patient groups

Internet-Based Brief Alcohol Intervention

Active Comparator group

Treatment:

Behavioral: Internet-Based Brief Alcohol Intervention

Unguided Internet-Based Cognitive Behavioral Therapy

Active Comparator group

Treatment:

Behavioral: Unguided Internet-Based Cognitive Behavioral Therapy

Guided Internet-Based Cognitive Behavioral Therapy

Active Comparator group

Treatment:

Behavioral: Guided Internet-Based Cognitive Behavioral Therapy