Identification and Treatment of Alcohol Problems in Primary Care (iTAPP)

April 28, 2026 updated by: University of Southern Denmark

iTAPP Study - Identification and Treatment of Alcohol Problems in Primary Care

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study protocol with a detailed description of the iTAPP Study is in preparation.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Fynen
      • Odense C, Fynen, Denmark, 5000
        • Unit for Clinical Alcohol Research, Clinical Institute, University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years or older
  • Affiliated with the participating general practices

Exclusion Criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Each participating clinic serves as its own control and as control for active clinics, in the stepped-wedge design. All clinics are inactive (no intervention) during the baseline period of three months.
Active Comparator: Active
Active clinics are trained in the intervention object (the 15-method) prior to switching to the active group. Clinics are enrolled as active clinics (intervention) in four steps (4-5 clinics in each step). The intervention is implemented into the clinic, and the staff are free to use the intervention in everyday work.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients exceeding the Danish national low-risk alcohol consumption limits
Time Frame: 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).
Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024).
Number of heavy drinking days per week in patients
Time Frame: 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.
Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likelihood of alcohol use being addressed during a consultation in general practice
Time Frame: Data is collected from enrollment in trial until the end of the trail (January 2023-August 2024).
The likelihood of consultations in which the topic of alcohol has been addressed. Alcohol related consultations are continuously registered in the patient filing system throughout the trial period. An alcohol related consultation is defined as a consultation registered with the ICD-10 code z006 and ICPC-2 code A97.
Data is collected from enrollment in trial until the end of the trail (January 2023-August 2024).
Frequency of use of biomarkers as a screening tool for harmful alcohol use
Time Frame: Data is collected 1 year prior to trial start/enrollment (January 2022-December 2023) and from enrollment in trial until the end of the trial (January 2023-August 2024).
The frequency of use in general practice. Biomarkers as a screening tool for harmful alcohol use comprise Gamma-Glutamyltransferase (GGT) and Alanine-Aminotransferase (ALAT). Data is obtained from Danish registers. The use of biomarkers as screening tool in the practices will be analyzed, comparing baseline levels to active (post-implementation) levels.
Data is collected 1 year prior to trial start/enrollment (January 2022-December 2023) and from enrollment in trial until the end of the trial (January 2023-August 2024).
Prescription rate of pharmacological treatment for alcohol problems
Time Frame: Data is collected 1 year prior to trial start/enrollment (January 2022-December 2023) and from enrollment in trial until the end of the trial (January 2023-August 2024).
The prescription rate in general practice. Pharmacological treatment for alcohol problems comprise Disulfiram, Naltrexone, Acamprosate, and Nalmefene. Data is obtained from Danish registers. The prescription rate in the practices will be analyzed, comparing baseline levels to active (post-implementation) levels.
Data is collected 1 year prior to trial start/enrollment (January 2022-December 2023) and from enrollment in trial until the end of the trial (January 2023-August 2024).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Investigators

  • Study Director: Anette S Nielsen, Professor, Unit of Clinical Alcohol Research, University of Southern Denmark
  • Principal Investigator: Jens Søgaard, Professor, Research Unit of General Practice Odense, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

August 31, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iTAPP project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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