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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 3,519
- Primary Endpoint
- Quantity-Frequency-Variability Index
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Internet-Based Brief Alcohol Intervention
Intervention: Internet-Based Brief Alcohol Intervention (Behavioral)
Unguided Internet-Based Cognitive Behavioral Therapy
Intervention: Unguided Internet-Based Cognitive Behavioral Therapy (Behavioral)
Guided Internet-Based Cognitive Behavioral Therapy
Intervention: Guided Internet-Based Cognitive Behavioral Therapy (Behavioral)
Outcomes
Primary Outcomes
Quantity-Frequency-Variability Index
Time Frame: From enrollment to 24 months.
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.
Quantity-Frequency-Variability Index: Alcohol Frequency
Time Frame: From enrollment to 24 months.
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.
Quantity-Frequency-Variability Index: Alcohol Quantity
Time Frame: From enrollment to 24 months.
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.
Quantity-Frequency-Variability Index: Alcohol Variability
Time Frame: From enrollment to 24 months.
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.
Secondary Outcomes
- 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.)
- EuroQol five-dimensions-five-levels: Index Value(Assessed at baseline and at 3, 6, 12, and 24 months follow-up.)
- EuroQol five-dimensions-five-levels: Visual Analogue Scale(Assessed at baseline and at 3, 6, 12, and 24 months follow-up.)
- Brief Symptom Inventory 18(Assessed at baseline and at 3, 6, 12, and 24 months follow-up.)
- Buss-Perry Aggression Questionnaire - Short-Form(Assessed at baseline and at 3, 6, 12, and 24 months follow-up.)
- Negative Effects Questionnaire(Assessed at the 3-month follow-up assessment.)
- Register Data: Danish Education and Income Statistics Registers(Will be collected for 10 years from enrollment.)
- Register Data: Danish National Patient Register(Will be collected for 10 years from enrollment.)
- Register Data: National Alcohol Treatment Register(Will be collected for 10 years from enrollment.)
- Register Data: National Register of Substance Abusers in treatment(Will be collected for 10 years from enrollment.)
- Register Data: Danish Prescription Register(Will be collected for 10 years from enrollment.)
- Register Data: Psychiatric Central Research Register(Will be collected for 10 years from enrollment.)
- Register Data: Cause of Death Register(Will be collected for 10 years from enrollment.)