Alcohol Abuse AlcoholismiTAPPNCT05916027
Identification and Treatment of Alcohol Problems in Primary Care
A study testing The 15-Method in people with Alcohol Abuse Alcoholism and General Practice, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse Alcoholism, General Practice, Screening and Brief Intervention
- What is being tested?
- The 15-Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 31 Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Affiliated with the participating general practices
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Unit for Clinical Alcohol Research, Clinical Institute, University of Southern Denmark
Odense C, Fynen, 5000
About this study
Official title: 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.
- Being tested
- The 15-Method
- Keywords
- Primary Care, Screening, Alcohol Use Disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 15-MethodBehavioural
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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 | Active comparator | 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. Receives: Behavioral: The 15-Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients exceeding the Danish national low-risk alcohol consumption limits
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).
Measured: 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
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.
Measured: Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024).
Secondary outcomes (3)
Likelihood of alcohol use being addressed during a consultation in general practice
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jan 2023
- Primary completion31 Aug 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Abuse AlcoholismStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anette S Nielsen, Professor, Study director, Unit of Clinical Alcohol Research, University of Southern DenmarkJens Søgaard, Professor, Principal investigator, Research Unit of General Practice Odense, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916027
- Sponsor's protocol ID
- iTAPP project
- Acronym
- iTAPP
- Status last verified
- Apr 2026
- First submitted
- 5 Oct 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38872214Olsen CDH, Volke KH, Scholer PN, Sondergaard J, Nielsen AS. Primary health care professionals' documentation and patients' recall of alcohol as a topic in consultations: quality assessment of data collection in the iTAPP study. BMC Res Notes. 2026 Mar 28;19(1):206. doi: 10.1186/s13104-026-07790-x.
PubMed 41904599
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iTAPP Study - Identification and Treatment of Alcohol Problems in Primary Care
- ClinicalTrials.gov ID
- NCT05916027
- Acronym / sponsor ID
- iTAPP / iTAPP project
- Keywords
- Primary Care, Screening, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 | Active comparator | Behavioral: The 15-MethodActive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Affiliated with the participating general practices
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 15-MethodThe 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. | Behavioural | Active |
Primary outcome
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).
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.
3 secondary outcomes
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Results publication: PubMed 38872214Scholer 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.
- Derived from this study: PubMed 41904599Olsen CDH, Volke KH, Scholer PN, Sondergaard J, Nielsen AS. Primary health care professionals' documentation and patients' recall of alcohol as a topic in consultations: quality assessment of data collection in the iTAPP study. BMC Res Notes. 2026 Mar 28;19(1):206. doi: 10.1186/s13104-026-07790-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anette S Nielsen, Professor study director
Unit of Clinical Alcohol Research, University of Southern Denmark
Jens Søgaard, Professor principal investigator
Research Unit of General Practice Odense, University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The 15-Method in people with Alcohol Abuse Alcoholism and General Practice, run by University of Southern Denmark at 1 site in 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05916027, which also lists 2 linked publications.
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 29 Apr 2026.