F10.2
Conditions
Interventions
Group 1: In the first study arm (3 sessions of CRA + RADIUS
intervention condition), participants receive 3 sessions of CRA lasting 30 minutes within 3 months and also have access to the RADIUS online tool during the treatment period.
Group 2: In the control c
control condition), the subjects receive 6 sessions of outpatient face-to-face therapy of 50 minutes each according to the CRA approach within 3 months.
Group 3: In the third study arm (6 sessions of
comparison group), instead of the 3 sessions, the participants receive 6 sessions of CRA lasting 50 minutes within 3 months and the RADIUS tool.
Sponsors
Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR) DLR Projektträger, Bereich Gesundheit, Abteilung Gesundheitswesen
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Current moderate (4-5 symptoms) or severe (>6 symptoms) alcohol use disorder (F10.2 according to DSM-5 and alcohol dependence according to ICD-10 F10.2). The criteria for alcohol dependence according to ICD-10 are also currently fulfilled (F10.2) - Participants must be undergoing withdrawal treatment at the time of inclusion - have a sufficient command of written and spoken German - be 18 to 65 years old
Exclusion criteria
Exclusion criteria: - Acquired brain damage/brain trauma, CNS-relevant somatic diseases (e.g. multiple sclerosis, epilepsy), serious somatic diseases requiring acute treatment - Current life-threatening crises with suicidal tendencies - self-harming behavior - Psychotic disorder (current or in the last year), - Eating disorder with body mass index < 15 - Substance dependence on centrally active substances other than alcohol and nicotine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary target criterion is the number of days of abstinence in the last 3 months, recorded using the Timeline Follow-Back Method (TLFB) twelve months after discharge from withdrawal treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary target criteria are defined by the number of days of abstinence in the last 3 months, collected via the Timeline Follow-Back Method (TLFB) three and six months after discharge from withdrawal treatment, the effect of the online tool RADIUS (by comparison group), the cumulative amount of alcohol consumed determined by the TLFB, the treatment drop-out rate determined by the number of participation in at least 50% of the sessions, the abstinence rate collected via the AUDIT, hospital days due to relapse or for relapse prevention, taken from patient data, and the global impairment determined by the AUDIT. 50 % of the sessions, the abstinence rate determined using the AUDIT, hospital days due to relapse or for relapse prevention, taken from the patient data, as well as the global impairment determined using the BSI long form and the level of social functioning using the WHODAS three months, six months and twelve months after discharge from withdrawal treatment. In addition, the use of outpatient, inpatient and partial inpatient treatment services as a result of renewed consumption, as well as treatment of the alcohol use disorder and laboratory parameters (GOT, GPT, gGT, CDT, MCV) and a breath alcohol test as secondary target criteria. | — |
Countries
Germany
Contacts
Public ContactMartina Bertino
Ev. Klinikum Bielefeld Universitätsklinikum OWL der Universität Bielefeld
Outcome results
None listed