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Identification and Treatment of Alcohol Problems in Primary Care

NCT05916027 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2023-01-01
Last updated
2026-04-29

Condition(s) studied

Alcohol Abuse AlcoholismGeneral PracticeScreening and Brief Intervention

Investigational drug(s) / intervention(s)

The 15-Method

The 15-Method: The 15-Method is a Screening and Brief Intervention method for identifying and treating alcohol problems in primary care. The method combines evidence-based approaches from specialized addiction treatment with screening and readily available treatment options in general practice to help identify and treat alcohol problems. The 15-method is based on Motivational Interviewing, Cognitive Behavioral Therapy and utilizes the Alcohol Use Disorder Identification Test (AUDIT) as a screening tool. The 15-Method contains three flexible steps: Identification of clinical problem related to alcohol; feedback and clinical work-up as needed; treatment. Treatment includes structured consultations (maximum of four) with patient home-work assignments, and can be combined with pharmacological treatment for alcohol problems.

Study summary

The Identification and Treatment of Alcohol Problems in Primary Care (iTAPP) Study is a pragmatic cluster randomized controlled intervention trial evaluating the effectiveness of the 15-Method as an identification and treatment tool for alcohol-related problems in Danish general practice. The 15-Method combines evidence-based approaches from specialized addiction treatment with screening and readily available treatment options in general practice to help identify and treat alcohol problems in a primary care setting. The method has shown promising results as a treatment tool in Sweden. A feasibility study of the 15-Method in Denmark suggested that the method can be implemented in Danish general practice.

The trial is led by the Unit for Clinical Alcohol Research at The University of Southern Denmark in collaboration with The Research Unit of General Practice Odense at The University of Southern Denmark.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 18 years or older * Affiliated with the participating general practices Exclusion Criteria: \- None

Primary outcome measure(s)

  • Proportion of patients exceeding the Danish national low-risk alcohol consumption limits — Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024).
    Using Timeline Follow Back one-week data from patient surveys. The Danish national low-risk alcohol consumption limit is maximum 10 standard units (1 unit = 12 grams of ethanol) per week and maximum 4 standard units on a single day. Patients are coded 1 (drinking above limits) or 0 (not drinking above limits).
  • Number of heavy drinking days per week in patients — Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024).
    The number of heavy drinking days (HDD) per week is derived from the Timeline Follow Back one-week (range 0-7 HDD/week) in patient surveys. A HDD is defined as \>4 standard units (1 unit = 12 grams of ethanol) on the same day. Is a sum of the number of days patients drink \>4 standard units.

Trial sites (1)

FacilityCityRegionStatus
Unit for Clinical Alcohol Research, Clinical Institute, University of Southern Denmark Odense C Fynen
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05916027 on ClinicalTrials.gov ↗ ← All trials in Denmark