Online Interventions to Prevent Alcohol Use Disorders

Официальное название

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

Обзор

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

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Quantity-Frequency-Variability Index [Срок оценки: From enrollment to 24 months.]
• Quantity-Frequency-Variability Index: Alcohol Frequency [Срок оценки: From enrollment to 24 months.]
• Quantity-Frequency-Variability Index: Alcohol Quantity [Срок оценки: From enrollment to 24 months.]
• Quantity-Frequency-Variability Index: Alcohol Variability [Срок оценки: From enrollment to 24 months.]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07373405 · S-20250010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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