F10.2 F10-F19
Conditions
Interventions
Group 1: Intervention group: Participants in this group receive, in addition to the standard outpatient addiction aftercare, a portable breath alcohol measurement device (“Dräger Companion med”) accom
Sponsors
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Zentrum für Integrative Psychiatrie (ZIP)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Diagnosed alcohol dependence according to ICD-10 criteria Expressed desire for permanent abstinence Capacity to consent; sufficient cognitive abilities Cognitive and physical ability to independently operate smartphone applications German as a native language or at least level C1 proficiency Start of outpatient therapy immediately following inpatient treatment
Exclusion criteria
Exclusion criteria: Current severe psychiatric or somatic comorbidity requiring (partial) inpatient treatment (except personality disorder) Day clinic or full inpatient follow-up treatment planned within the next 6 months Participation in other clinical studies No fixed residence Lack of capacity to consent Known intellectual disability Belonging to a vulnerable group (pregnant and breastfeeding women, prisoners, asylum seekers)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to identify factors that may influence post-inpatient therapy adherence in alcohol-dependent patients following inpatient detoxification. Specifically, the study aims to determine whether the use of technological tools—such as a home-use breathalyzer in combination with an app—can improve therapy adherence. To this end, the number of attended appointments at the psychiatric outpatient clinic will be compared between participants with and without the device as well as participants who started using the device immediately after inpatient treatment and those who started using the device 3 months after inpatient treatment. Appointment adherence will be assessed over a 24-week period from the start of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary analyses will focus on abstinence behavior, relapse patterns, and psychological comorbid factors. Abstinence behavior is operationalized using multiple criteria: the proportion of abstinent patients at 12 and 24 weeks (defined as: no breath alcohol measurements > 0.05‰, no missed measurements for more than two consecutive days, and no self-reported relapses), the number of days until the first relapse, relapse frequency (number of days with renewed consumption after the first relapse), and relapse severity (amount of alcohol consumed in grams of ethanol per relapse, based on standardized conversion factors). Additionally, the number of days with documented concurrent substance use and the quantity of other substances consumed are recorded. For psychological assessment, the following instruments are used: the Quick Inventory of Depressive Symptomatology (QIDS) for depression, the Generalized Anxiety Disorder Scale (GAD-7) for anxiety, and the Mental Health Inventory (MHI-5) for subjective well-being. These are administered at six time points (t = 0, 2, 4, 6, 12, and 24 weeks). Craving is assessed at each time point using a visual analog scale (0–10). At study entry, participants additionally complete the Self-Efficacy Scale developed by Schwarzer and Jerusalem. The moderating effects of depression, anxiety, and craving on the relationship between breath alcohol monitoring and abstinence behavior are analyzed as part of the secondary hypotheses. Furthermore, differences in treatment outcomes based on sociodemographic factors such as gender, employment status, relationship status, and previous motivational therapy are explored. Treatment success is additionally operationalized as a composite score comprising three standardized components: relapse latency (days until first relapse), proportion of abstinent days, and subjective quality of life (MHI-5). These components are z-standardized and aggregated, with higher scores indicating better treatment outcome | — |
Countries
Germany
Outcome results
None listed