Menu
Not yet recruiting NCT07373405

Online Interventions to Prevent Alcohol Use Disorders

No phase Interventional Alcohol Use Disorder (AUD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internet-Based Brief Alcohol Intervention, Unguided Internet-Based Cognitive Behavioral Therapy, Guided Internet-Based Cognitive Behavioral Therapy.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder (AUD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Quantity-Frequency-Variability Index [Time frame: From enrollment to 24 months.]
  • Quantity-Frequency-Variability Index: Alcohol Frequency [Time frame: From enrollment to 24 months.]
  • Quantity-Frequency-Variability Index: Alcohol Quantity [Time frame: From enrollment to 24 months.]
  • Quantity-Frequency-Variability Index: Alcohol Variability [Time frame: From enrollment to 24 months.]
Secondary outcome measures (12)
  • Client Satisfaction Questionnaire Adapted to Internet-Based Interventions [Time frame: Assessed at the 3-month follow-up assessment.]
  • System Usability Scale [Time frame: Assessed at the 3-month follow-up assessment.]
  • Readiness-to-Change Questionnaire - Treatment Version [Time frame: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.]
  • Alcohol Use Disorders Identification Test [Time frame: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.]
  • Drug Use Disorders Identification Test [Time frame: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.]
  • EuroQol five-dimensions-five-levels: Index Value [Time frame: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.]
  • EuroQol five-dimensions-five-levels: Visual Analogue Scale [Time frame: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.]
  • Brief Symptom Inventory 18 [Time frame: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.]
  • Buss-Perry Aggression Questionnaire - Short-Form [Time frame: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.]
  • Negative Effects Questionnaire [Time frame: Assessed at the 3-month follow-up assessment.]
  • Register Data: Danish Education and Income Statistics Registers [Time frame: Will be collected for 10 years from enrollment.]
  • Register Data: Danish National Patient Register [Time frame: Will be collected for 10 years from enrollment.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07373405 · S-20250010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗