Dual DiagnosisNCT07728968
The 15-Mental Project: Implementation and Evaluation of the 15-Mental in a Mental Health Hospital Setting
A study testing 15-Mental. in people with Dual Diagnosis and Alcohol Use Disorder, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The present project will implement and evaluate the effectiveness of a novel, but simple model for addressing and treating alcohol problems among patients admitted to outpatient treatment at mental health hospitals, called the '15-Mental'. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dual Diagnosis, Alcohol Use Disorder, Hazardous Alcohol Use
- What is being tested?
- 15-Mental.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2025to 31 Mar 2028
- 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
STAFF - Inclusion criteria:
- Employed at the Outpatient Mental Health Hospital in Odense (Lokalpsykiatri Odense) during the study period.
- Has patient contact and is involved in patient care, either during intake/discharge, diagnostic investigation, and/or the patient's psychiatric treatment course at the hospital.
STAFF - Exclusion criteria:
- Junior doctors, interns, and students employed for less than 6 months at the Outpatient Mental Health Hospital in Odense (Lokalpsykiatri Odense).
PATIENTS - Inclusion criteria:
- Enrolled or discharged from treatment at the Outpatient Mental Health Hospital in Odense (Lokalpsykiatri Odense) during the study period.
- ≥ 18 years old (the Outpatient Mental Health Hospital in Odense (Lokalpsykiatri Odense) only provides treatment for patients ≥ 18 years old).
- For participants in qualitative interviews, patients are required to speak and understand either Danish or English to ensure informed consent to participate.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Unit for Clinical Alcohol Research, Research Unit of Psychiatry, Odense University Hospital; University of Southern Denmark
Odense
About this study
Official title: The 15-Mental Project: Implementation and Evaluation of the 15-Mental in a Mental Health Hospital Setting - Identifying and Addressing Alcohol Problems at Early Stages
The present project will implement and evaluate the effectiveness of a novel, but simple model for addressing and treating alcohol problems among patients admitted to outpatient treatment at mental health hospitals, called the '15-Mental'. The 15-Mental supports healthcare professionals in addressing patients' use of alcohol and in helping patients reduce their intake of alcohol if the alcohol intake potentially may affect the patients' primary illness, symptoms, and/or treatment course. The 15-Mental is based on the 15-Method that was originally developed as a toolbox for clinicians in general practice. In 2024, the 15-Method was feasibility-tested in a mental health setting, and based on the feasibility study, the 15-Mental was developed as an adapted version of the original 15-Method.
The present study aims to assess if the 15-Mental, adapted particularly to mental health settings, will lead to a reduction in the proportion of patients with a risky alcohol intake. It will also be investigated if successful implementation of the model will increase patients' adherence to treatment for mental health disorders, prevent premature dropout of treatment, and increase the patients' quality of life. Furthermore, staff's and patients' perspectives on and experiences with the 15-Mental will be explored.
Read the detailed description
The 15-Mental is a strategy to increase staff's awareness towards alcohol use that may have an impact on patients' symptoms and treatment courses, it is not possible to perform a randomized controlled trial with individual patient randomization. Staff cannot be asked to at random ignore or pay attention to the use of alcohol among patients. The study is thus designed as a stepped wedge cluster-randomized controlled study. This involves randomization of the 15 teams at the Outpatient Mental Health Hospital Odense, from status of control teams to status of teams trained in the 15-Mental ('trained teams') during the study period.
The 15 teams at the Outpatient Mental Health Hospital will be randomized into five clusters of three teams each. During the first 8 months of the study period, all teams will be considered control teams, offering treatment as usual (TAU). Following the 8 months control period, the first cluster of teams will undergo training in the 15-Mental and thereby crossing over to becoming trained teams, having increased awareness on alcohol use in addition to offering TAU. Every four months, a new cluster of teams will transition from control teams to trained teams. The teams in a cluster will undergo training in the 15-Mental within the two weeks prior to their transition, thereby becoming trained teams. After 17 months, all teams will have undergone training in the 15-Mental and transitioned into being trained teams. For the remaining 6 months of the study period, the 15-Mental will thus be implemented in the entire Outpatient Mental Health Hospital.
- Conditions
- Dual Diagnosis, Alcohol Use Disorder, Hazardous Alcohol Use, Screening and Brief Intervention
- Being tested
- 15-Mental.
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15-Mental.Other
The 15-Mental is a simple model for identifying and treating alcohol problems among patients admitted for outpatient treatment at mental health hospitals. The model targets patients with mild to moderate alcohol problems and combines elements of cognitive behavioral therapy, motivational interviewing, and pharmacological treatment, if needed. The 15-Mental is based on pragmatic screening and includes written material for both healthcare professionals and patients. It can be viewed as a toolbox for clinicians, making it easier to assess when to talk about alcohol with patients, and what to offer if a patient reports to be drinking at a level that might interact with the symptoms the patient presents with.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Treatment as usual |
| Intervention | Experimental | 15-Mental Receives: Other: 15-Mental. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazardous alcohol intake
Proportion of patients with hazardous alcohol intake at post-treatment (i.e., treatment discharge). Assessed using the AUDIT questionnaire. Hazardous alcohol intake is defined as a score of 8 or above on the AUDIT questionnaire. 0 represents no hazardous alcohol intake (i.e., AUDIT score <8) and 1 represents hazardous alcohol intake (i.e., AUDIT score ≥ 8).
Measured: Immediately after the treatment course.
Secondary outcomes (6)
Quality of life at treatment discharge
Patients' quality of life at post-treatment (i.e., treatment discharge). Assessed using the WHO-5 Well-being Index, ranging from 0 to 100. A score of 0 represents the worst possible quality of life, and a score of 100 represents the best possible quality of life.
Measured: Immediately after the treatment course.
Adherence to psychiatric treatment
Patients' adherence to psychiatric treatment. Measured as the proportion of no-shows for appointments and dropouts from the psychiatric treatment.
Measured: Through the treatment course.
Health care utilization
Proportion of patients using health care services.
Measured: From 2 years before until 2 years after the trial period.
Pharmacological treatment for alcohol use disorders
Proportion of patients filling in prescriptions for pharmacological treatment for alcohol use disorders. Pharmacological treatment includes Acamprosate, Naltrexone, Nalmefene, and Disulfiram.
Measured: From 2 years before until 2 years after the trial period.
Specialized treatment for alcohol use disorders
Proportion of patients being enrolled in specialized treatment for alcohol use disorders (in all sectors).
Measured: From 2 years before until 2 years after the trial period.
User perspectives and experiences
Staff's perspectives on and experiences with lacking and using the 15-Mental in their clinical work, including perceived and observed changes in practice among staff. Patients' perspectives on and experiences with lacking and using the 15-Mental material and exploring their drinking habits. Outcomes are assessed qualitatively by means of interviews and quantitatively by means of questionnaires.
Measured: Pre-intervention, post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Nov 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual DiagnosisStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, Region Syddanmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728968
- Sponsor's protocol ID
- The 15-Mental Project
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 15-Mental Project: Implementation and Evaluation of the 15-Mental in a Mental Health Hospital Setting - Identifying and Addressing Alcohol Problems at Early Stages
- ClinicalTrials.gov ID
- NCT07728968
- Acronym / sponsor ID
- The 15-Mental Project
- Conditions
- Dual Diagnosis, Alcohol Use Disorder, Hazardous Alcohol Use, Screening and Brief Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, Region Syddanmark
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 27 Jul 2026 (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 present project will implement and evaluate the effectiveness of a novel, but simple model for addressing and treating alcohol problems among patients admitted to outpatient treatment at mental health hospitals, called the '15-Mental'. The 15-Mental supports healthcare professionals in addressing patients' use of alcohol and in helping patients reduce their intake of alcohol if the alcohol intake potentially may affect the patients' primary illness, symptoms, and/or treatment course. The 15-Mental is based on the 15-Method that was originally developed as a toolbox for clinicians in general practice. In 2024, the 15-Method was feasibility-tested in a mental health setting, and based on the feasibility study, the 15-Mental was developed as an adapted version of the original 15-Method.
The present study aims to assess if the 15-Mental, adapted particularly to mental health settings, will lead to a reduction in the proportion of patients with a risky alcohol intake. It will also be investigated if successful implementation of the model will increase patients' adherence to treatment for mental health disorders, prevent premature dropout of treatment, and increase the patients' quality of life. Furthermore, staff's and patients' perspectives on and experiences with the 15-Mental will be explored.
Detailed description
The 15-Mental is a strategy to increase staff's awareness towards alcohol use that may have an impact on patients' symptoms and treatment courses, it is not possible to perform a randomized controlled trial with individual patient randomization. Staff cannot be asked to at random ignore or pay attention to the use of alcohol among patients. The study is thus designed as a stepped wedge cluster-randomized controlled study. This involves randomization of the 15 teams at the Outpatient Mental Health Hospital Odense, from status of control teams to status of teams trained in the 15-Mental ('trained teams') during the study period.
The 15 teams at the Outpatient Mental Health Hospital will be randomized into five clusters of three teams each. During the first 8 months of the study period, all teams will be considered control teams, offering treatment as usual (TAU). Following the 8 months control period, the first cluster of teams will undergo training in the 15-Mental and thereby crossing over to becoming trained teams, having increased awareness on alcohol use in addition to offering TAU. Every four months, a new cluster of teams will transition from control teams to trained teams. The teams in a cluster will undergo training in the 15-Mental within the two weeks prior to their transition, thereby becoming trained teams. After 17 months, all teams will have undergone training in the 15-Mental and transitioned into being trained teams. For the remaining 6 months of the study period, the 15-Mental will thus be implemented in the entire Outpatient Mental Health Hospital.
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 | –Treatment as usual |
| Intervention | Experimental | Other: 15-Mental.15-Mental |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 15-Mental.The 15-Mental is a simple model for identifying and treating alcohol problems among patients admitted for outpatient treatment at mental health hospitals. The model targets patients with mild to moderate alcohol problems and combines elements of cognitive behavioral therapy, motivational interviewing, and pharmacological treatment, if needed. The 15-Mental is based on pragmatic screening and includes written material for both healthcare professionals and patients. It can be viewed as a toolbox for clinicians, making it easier to assess when to talk about alcohol with patients, and what to offer if a patient reports to be drinking at a level that might interact with the symptoms the patient presents with. | Other | Intervention |
Primary outcome
Hazardous alcohol intake
Time frame: Immediately after the treatment course.
Proportion of patients with hazardous alcohol intake at post-treatment (i.e., treatment discharge). Assessed using the AUDIT questionnaire. Hazardous alcohol intake is defined as a score of 8 or above on the AUDIT questionnaire. 0 represents no hazardous alcohol intake (i.e., AUDIT score <8) and 1 represents hazardous alcohol intake (i.e., AUDIT score ≥ 8).
6 secondary outcomes
Quality of life at treatment discharge
Time frame: Immediately after the treatment course.
Adherence to psychiatric treatment
Time frame: Through the treatment course.
Health care utilization
Time frame: From 2 years before until 2 years after the trial period.
Pharmacological treatment for alcohol use disorders
Time frame: From 2 years before until 2 years after the trial period.
Specialized treatment for alcohol use disorders
Time frame: From 2 years before until 2 years after the trial period.
User perspectives and experiences
Time frame: Pre-intervention, post-intervention
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 27 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15-Mental. in people with Dual Diagnosis and Alcohol Use Disorder, 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?
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 27 Jul 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?
Hazardous alcohol intake (time frame: Immediately after the treatment course.). 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 27 Jul 2026.