The 15-Mental Project: Implementation and Evaluation of the 15-Mental in a Mental Health Hospital… (NCT07728968) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The 15-Mental Project: Implementation and Evaluation of the 15-Mental in a Mental Health Hospital Setting
Denmark14 participantsStarted 2025-11-01
Plain-language 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'. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hazardous alcohol intake
Timeframe: Immediately after the treatment course.