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

NCT07728968 | Active Not Recruiting

• 1 other identifier: The 15-Mental Project
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Immediately after the treatment course.

Secondary Outcomes (6)

• Quality of life at treatment discharge

  Immediately after the treatment course.

• Adherence to psychiatric treatment

  Through the treatment course.

• Health care utilization

  From 2 years before until 2 years after the trial period.

• Pharmacological treatment for alcohol use disorders

  From 2 years before until 2 years after the trial period.

• Specialized treatment for alcohol use disorders

  From 2 years before until 2 years after the trial period.

Study Arms (2)

Control

NO INTERVENTION

Treatment as usual

Intervention

EXPERIMENTAL

15-Mental

Other: 15-Mental.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Junior doctors, interns, and students employed for less than 6 months at the Outpatient Mental Health Hospital in Odense (Lokalpsykiatri Odense).
• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead
• TrygFonden, Denmark: collaborator
• Region Syddanmark: collaborator

Study Sites (1)

Unit for Clinical Alcohol Research, Research Unit of Psychiatry, Odense University Hospital; University of Southern Denmark

Odense, Denmark

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster randomized controlled trial

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 27, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)