Skip to content

The 15-Mental Project: Implementation and Evaluation of the 15-Mental in a Mental Health Hospital Setting

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07728968
Enrollment
14
Registered
2026-07-27
Start date
2025-11-01
Completion date
2028-03-31
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Dual Diagnosis, Hazardous Alcohol Use, Screening and Brief Intervention

Brief 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.

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.

Interventions

OTHER15-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.

Sponsors

University of Southern Denmark
Lead SponsorOTHER
TrygFonden, Denmark
CollaboratorINDUSTRY
Region Syddanmark
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Stepped-wedge cluster randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Hazardous alcohol intakeImmediately 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).

Secondary

MeasureTime frameDescription
Quality of life at treatment dischargeImmediately after the treatment course.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.
Adherence to psychiatric treatmentThrough the treatment course.Patients' adherence to psychiatric treatment. Measured as the proportion of no-shows for appointments and dropouts from the psychiatric treatment.
Health care utilizationFrom 2 years before until 2 years after the trial period.Proportion of patients using health care services.
Pharmacological treatment for alcohol use disordersFrom 2 years before until 2 years after the trial period.Proportion of patients filling in prescriptions for pharmacological treatment for alcohol use disorders. Pharmacological treatment includes Acamprosate, Naltrexone, Nalmefene, and Disulfiram.
Specialized treatment for alcohol use disordersFrom 2 years before until 2 years after the trial period.Proportion of patients being enrolled in specialized treatment for alcohol use disorders (in all sectors).
User perspectives and experiencesPre-intervention, post-interventionStaff'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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026