Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07728968

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Odense, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Quality of life at treatment discharge

    Time frame: Immediately 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.

  2. Adherence to psychiatric treatment

    Time frame: Through the treatment course.

    Patients' adherence to psychiatric treatment. Measured as the proportion of no-shows for appointments and dropouts from the psychiatric treatment.

  3. Health care utilization

    Time frame: From 2 years before until 2 years after the trial period.

    Proportion of patients using health care services.

  4. Pharmacological treatment for alcohol use disorders

    Time frame: From 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.

  5. Specialized treatment for alcohol use disorders

    Time frame: From 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).

  6. User perspectives and experiences

    Time frame: Pre-intervention, post-intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Region Syddanmark
  • TrygFonden, Denmark

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.