Identification and Treatment of Alcohol Problems in Primary Care

NCT ID: NCT05916027

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Abuse Alcoholism General Practice Screening and Brief Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Stepped-wedge cluster randomized controlled trial.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

The 15-Method

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anette S Nielsen, Professor

Role: STUDY_DIRECTOR

Unit of Clinical Alcohol Research, University of Southern Denmark

Jens Søgaard, Professor

Role: PRINCIPAL_INVESTIGATOR

Research Unit of General Practice Odense, University of Southern Denmark

Locations

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Unit for Clinical Alcohol Research, Clinical Institute, University of Southern Denmark

Odense C, Fynen, Denmark

Site Status

Countries

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Denmark

References

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Scholer PN, Volke KH, Andreasson S, Rasmussen S, Sondergaard J, Nielsen AS. The identification and treatment of alcohol problems in primary care (iTAPP) study: protocol for a stepped wedge cluster randomized control trial testing the 15-method in a primary care setting. Addict Sci Clin Pract. 2024 Jun 13;19(1):49. doi: 10.1186/s13722-024-00474-6.

Reference Type RESULT
PMID: 38872214 (View on PubMed)

Other Identifiers

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iTAPP project

Identifier Type: -

Identifier Source: org_study_id

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