Online Interventions to Prevent Alcohol Use Disorders
ConditionAlcohol Use Disorder (AUD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern Denmark
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Receiving other psychological treatment
Being suicidal or having severe comorbid psychiatric disorders (e.g., psychotic disorders).
Trial design
Design model
Parallel
Treatments tested in this trial
Internet-Based Brief Alcohol Intervention
BehavioralBrief 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.
Unguided Internet-Based Cognitive Behavioral Therapy
BehavioralUnguided 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.
Guided Internet-Based Cognitive Behavioral Therapy
BehavioralGuided 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.
Treatment groups
3,519 Participants
are divided into 3 treatment groupsGroup A: Internet-Based Brief Alcohol InterventionActive comparator 1 intervention
Group B: Unguided Internet-Based Cognitive Behavioral TherapyActive comparator 1 intervention
Group C: Guided Internet-Based Cognitive Behavioral TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quantity-Frequency-Variability Index
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.
Time frame
From enrollment to 24 months.2
Quantity-Frequency-Variability Index: Alcohol Frequency
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.
Time frame
From enrollment to 24 months.3
Quantity-Frequency-Variability Index: Alcohol Quantity
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.
Time frame
From enrollment to 24 months.4
Quantity-Frequency-Variability Index: Alcohol Variability
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.
Time frame
From enrollment to 24 months.Secondary outcomes
1
Client Satisfaction Questionnaire Adapted to Internet-Based Interventions
The Client Satisfaction Questionnaire Adapted to Internet-Based Interventions includes 8 items measuring global satisfaction with web-based interventions. Each item is rated on a 4-point Likert scale ranging from 1 (does not apply to me) to 4 (does totally apply to me). The minimum score is 8 and the maximum score is 32. Higher scores indicate higher satisfaction.
Time frame
Assessed at the 3-month follow-up assessment.2
System Usability Scale
The 10-item System Usability Scale will be used to measure subjective usability of internet-based interventions. The items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The minimum score is 0 and the maximum score is 100. Higher scores indicate better usability.
Time frame
Assessed at the 3-month follow-up assessment.3
Readiness-to-Change Questionnaire - Treatment Version
The Readiness-to-Change Questionnaire - Treatment Version is a 12-item measure designed to assess the respondent's stated intentions regarding changing their drinking behaviour. It includes three subscales representing different stages of change: (1) Pre-contemplation, (2) Contemplation, and (3) Action. Each subscale consists of four items, and responses are rated on a 5-point Likert Scale ranging from -2 (strongly disagree) to +2 (strongly agree). Total scores can range from -24 to +24. Higher scores on a specific subscale indicate greater alignment with that stage of change.
Time frame
Assessed at baseline and at 3, 6, 12, and 24 months follow-up.4
Alcohol Use Disorders Identification Test
The Alcohol Use Disorders Identification Test consists of 10 items assessing alcohol consumption, drinking behaviours, and alcohol-related problems. Items 1 to 8 are scored 0, 1, 2, 3 or 4, while items 9 and 10 are scored 0, 2 or 4. The total score can range from 0 to 40, with 0 indicating an abstainer who has never experienced any alcohol-related problems. In the study, only individuals who score ≥8 for men and ≥6 for women will be included, as scores from 1 to 7 for men and 1 to 5 for women suggest low-risk alcohol consumption according to WHO guidelines. Scores of 8 to 15 for men and 6 to 13 for women indicate hazardous or harmful alcohol consumption, while scores above 15 for men and above 13 for women suggest the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Time frame
Assessed at baseline and at 3, 6, 12, and 24 months follow-up.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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