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Alcohol Use Disorder (AUD)NCT07373405

Online Interventions to Prevent Alcohol Use Disorders

A study testing Internet-Based Brief Alcohol Intervention, Unguided Internet-Based Cognitive Behavioral Therapy and Guided Internet-Based Cognitive Behavioral Therapy in people with Alcohol Use Disorder (AUD), run by University of Southern Denmark.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Use Disorder (AUD)
What is being tested?
Internet-Based Brief Alcohol Intervention, Unguided Internet-Based Cognitive Behavioral Therapy and Guided Internet-Based Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,519 participants
Where
No sites listed yet
Study dates
1 Feb 2026to Dec 2038
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Angelina Isabella Mellentin, Ph.D. contact

+45 65 41 13 31

amellentin@health.sdu.dk

Nicolai Nør-Hansen, Pregraduate Psychology student contact

+45 21 48 58 75

nnoer21@student.sdu.dk

About this study

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

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.

Read more

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

Being tested
Internet-Based Brief Alcohol Intervention, Unguided Internet-Based Cognitive Behavioral Therapy, Guided Internet-Based Cognitive Behavioral Therapy
Keywords
Alcohol Use Disorder, Internet-Based Interventions, Machine Learning, Non-treatment Seekers, Stepped-Care
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-Based Brief Alcohol InterventionBehavioural

    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.

  • Unguided Internet-Based Cognitive Behavioral TherapyBehavioural

    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.

  • Guided Internet-Based Cognitive Behavioral TherapyBehavioural

    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.

Study groups in NCT07373405
Study groupRoleWhat they receive
Internet-Based Brief Alcohol InterventionActive comparatorNot described
Receives: Behavioral: Internet-Based Brief Alcohol Intervention
Unguided Internet-Based Cognitive Behavioral TherapyActive comparatorNot described
Receives: Behavioral: Unguided Internet-Based Cognitive Behavioral Therapy
Guided Internet-Based Cognitive Behavioral TherapyActive comparatorNot described
Receives: Behavioral: Guided Internet-Based Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: From enrollment to 24 months.

Secondary outcomes (17)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.

  5. Drug Use Disorders Identification Test

    The Drug Use Disorders Identification Test consists of 11 items assessing drug use patterns and drug-related problems (excluding alcohol). Items 1 to 9 are scored 0, 1, 2, 3 or 4, while items 10 and 11 and are scored 0, 2 or 4. The total possible score ranges from 0 to 44, with higher scores reflecting higher drug dependence. A score of 6 for men and 2 for women indicates drug-related problems or harmful drug consumption, while a score of greater than 24 for both sexes suggests probable dependence on one or more drugs.

    Measured: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.

  6. EuroQol five-dimensions-five-levels: Index Value

    The EuroQol five-dimensions-five-levels assesses quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels of severity for each (no problems, slight problems, moderate problems, severe problems, or extreme problems). The health state profile is converted into a single index value using the Danish value set (Jensen et al., 2023). In this context, the maximum score is 1.0, while the minimum score is -0.757. Higher scores indicates higher quality of life.

    Measured: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.

  7. EuroQol five-dimensions-five-levels: Visual Analogue Scale

    Participants rate their overall health on a vertical visual analogue scale. The scales ranges from 0 to 100. Higher scores indicate greater overall health perception.

    Measured: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.

  8. Brief Symptom Inventory 18

    The Brief Symptom Inventory 18 is an 18-item questionnaire designed to assess psychological distress. Each item describes a symptom, and respondents rate the extent to which they have been bothered by the symptom over the past week on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). Scores for all items are summarized on the Global Severity Index. The minimum score is 0 and the maximum score is 72. Higher scores indicate higher levels of psychological distress.

    Measured: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.

  9. Buss-Perry Aggression Questionnaire - Short-Form

    The 12-item Buss-Perry Aggression Questionnaire - Short-Form consists of four subscales measuring hostility, anger, and physical and verbal aggression. Each subscale consists of three items, and responses are rated on a 5-point Likert scale ranging from 1 (extremely unlike me) to 5 (extremely like me). The minimum score is 12 and the maximum score is 60. Higher scores indicate higher levels of aggression.

    Measured: Assessed at baseline and at 3, 6, 12, and 24 months follow-up.

  10. Negative Effects Questionnaire

    The Negative Effects Questionnaire includes 20 items rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely), distinguishing between negative effects attributed to the intervention and those potentially caused by other factors. The minimum score is 0 and the maximum score is 80. Higher scores indicate a higher burden of negative effects.

    Measured: Assessed at the 3-month follow-up assessment.

  11. Register Data: Danish Education and Income Statistics Registers

    Information on highest achieved education, employment, and economy will be retrieved.

    Measured: Will be collected for 10 years from enrollment.

  12. Register Data: Danish National Patient Register

    Data on inpatient and outpatient Alcohol Use Disorder-related contacts, prior Alcohol Use Disorder treatment, and other comorbidities will be collected.

    Measured: Will be collected for 10 years from enrollment.

  13. Register Data: National Alcohol Treatment Register

    Data on Alcohol Use Disorder treatment duration and intensity, treatment retention and type of treatment conclusion (i.e., dropout or completion), and prior Alcohol Use Disorder treatment will be retrieved.

    Measured: Will be collected for 10 years from enrollment.

  14. Register Data: National Register of Substance Abusers in treatment

    Data on Alcohol Use Disorder treatment duration and intensity, treatment retention and type of treatment conclusion (i.e., dropout or completion), and prior Alcohol Use Disorder treatment will be retrieved.

    Measured: Will be collected for 10 years from enrollment.

  15. Register Data: Danish Prescription Register

    Data on prescription of pharmacological treatment targeting Alcohol Use Disorder (e.g. disulfiram, naltrexone) and number of released receipts will be retrieved.

    Measured: Will be collected for 10 years from enrollment.

  16. Register Data: Psychiatric Central Research Register

    Data on inpatient and outpatient Alcohol Use Disorder-related contacts, prior Alcohol Use Disorder treatment, and other comorbidities will be collected.

    Measured: Will be collected for 10 years from enrollment.

  17. Register Data: Cause of Death Register

    Data on the date and primary cause of death, including both internal and external causes (accident, suicide, or murder), will be retrieved.

    Measured: Will be collected for 10 years from enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2038 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,519 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07373405
Sponsor's protocol ID
S-20250010
Status last verified
Jan 2026
First submitted
10 Dec 2025
Last updated
28 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Internet-Based Brief Alcohol Intervention, Unguided Internet-Based Cognitive Behavioral Therapy and Guided Internet-Based Cognitive Behavioral Therapy in people with Alcohol Use Disorder (AUD), run by University of Southern Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Angelina Isabella Mellentin, Ph.D. (+45 65 41 13 31, amellentin@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantity-Frequency-Variability Index (time frame: From enrollment to 24 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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