Unit for Clinical Alcohol Research, Research Unit of Psychiatry, Odense University Hospital; University of Southern Denmark
Odense, Denmark
NCT Number: NCT07728968
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Odense, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
STAFF - Inclusion criteria:
STAFF - Exclusion criteria:
PATIENTS - Inclusion criteria:
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.
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).
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.
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.
Time frame: From 2 years before until 2 years after the trial period.
Proportion of patients using health care services.
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.
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).
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.
University of Southern Denmark
Other
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
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.
NCT02082678
Alcohol Use Disorder, Alcohol-Related Disorders
Dallas, Texas, United States
View Trial DetailsNCT05054738
Alcohol-Related Disorders, Alcoholism
Charleston, South Carolina, United States
View Trial DetailsNCT02233738
Alcohol-Related Disorders, Alcoholism
Charleston, South Carolina, United States
View Trial DetailsNCT00706901
Alcohol Dependence, Alcohol-Related Disorders
Charleston, South Carolina, United States
View Trial Details