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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03339674
Other study ID # OD 113/2-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date December 31, 2019

Study information

Verified date April 2020
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Based on previous research (Odenwald & Semrau, 2012) the investigators know that psychoeducation on comorbid mental disorders during residential alcohol detoxification can improve subsequent treatment utilization. In this study they will study a hypothesized psychological mechanism that contributes to this behavior change.

The investigators will recruit alcohol dependent patients in residential detox treatment who all receive Treatment as Usual. Participants will be randomly assigned to an additional psychoeducational group therapy (intervention group) or to an additional neuropsychological group training (control group). Measurements will take place on the day before study inclusion, one week later and one month after release from index residential treatment. Measurements will include alcohol-related risk perception, alcohol use, treatment motivation, comorbid psychiatric symptoms and whether the patient has regularly completed treatment and whether he/she has been transferred to subsequent treatment. Furthermore, six months after release from index treatment information on re-admission to the clinic is assessed from patient files.

The investigators hypothesize that the behavioral effects of psychoeducational group intervention will be mediated by adaptive changes of the individual's alcohol-related risk perception.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date December 31, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Alcohol Dependence (according to ICD-10)

Exclusion Criteria:

- treatment episode is acute crisis intervention

- acute psychosis

- acute suicidality

- no command of German language (reading writing)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychoeducational Group Intervention on Alcohol Drinking Related to Stress
Manualized and standardized psychotherapeutic group intervention with three sessions of 60 min duration each which are to be delivered in a one-week period.
Cognitive Training
Manualized and standardized psychotherapeutic group intervention with three sessions of 60 min duration each which are to be delivered in a one-week period.

Locations

Country Name City State
Germany Center for Psychiatry Reichenau Reichenau

Sponsors (2)

Lead Sponsor Collaborator
University of Konstanz Centre for Psychiatry Reichenau, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Odenwald M, Semrau P. Reducing dropout among traumatized alcohol patients in detoxification treatment: a pilot intervention study. Eur Addict Res. 2012;18(2):54-63. doi: 10.1159/000333336. Epub 2011 Dec 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Questionnaire on Alcohol-related Risk Perception The patient's self-reported rating of the patient's own perception of alcohol-related risks in the German Questionnaire on Alcohol-related Risk Perception (Klepper, Odenwald & Rockstroh, 2016). one week
Secondary Treatment completion Binary variable: The patient regularly completes the residential detox treatment or he/she can prematurely end the treatment (treatment drop out). One month after study completion
Secondary Transfer to subsequent treatment Binary variable: Patient is directly transferred from detox treatment unit to subsequent alcohol in-patient or day-clinic treatment. One month after study completion
Secondary Alcohol relapse Drinking alcohol after treatment four weeks
Secondary Readmission to detox treatment The patient is readmitted to the same alcohol detox treatment unit six months
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