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Addiction Risk: Psychoeducational Intervention to Change Risk Perception Among Alcohol Patients in Residential Treatment

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Psychoeducational Group Intervention on Alcohol Drinking Related to Stress
Cognitive Training
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Center for Psychiatry Reichenau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Psychoeducational Group Intervention on Alcohol Drinking Related to Stress: Psychological group intervention with 3 sessions of 60 min (Odenwald & Semrau, 2012). Contains psychoeducation on alcohol drinking related to stress and PTSD.

Cognitive Training: Psychological group intervention with 3 sessions of 60 min. The content is paper-and-pencil based cognitive training of memory and attention functions.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Treatment completion
Binary variable: The patient regularly completes the residential detox treatment or he/she can prematurely end the treatment (treatment drop out).
Transfer to subsequent treatment
Binary variable: Patient is directly transferred from detox treatment unit to subsequent alcohol in-patient or day-clinic treatment.
Alcohol relapse
Drinking alcohol after treatment
Readmission to detox treatment
The patient is readmitted to the same alcohol detox treatment unit

Full Information

First Posted
May 10, 2017
Last Updated
April 23, 2020
Sponsor
University of Konstanz
Collaborators
Centre for Psychiatry Reichenau, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03339674
Brief Title
Addiction Risk: Psychoeducational Intervention to Change Risk Perception Among Alcohol Patients in Residential Treatment
Official Title
Sub-Project No 8 of the Research Group RISKDYNAMICS: Addiction Risk - the Dynamic of Risk Perception and Risk Behavior in Alcohol Dependence, Work Package 1, Study 1.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Centre for Psychiatry Reichenau, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Psychoeducational Group Intervention on Alcohol Drinking Related to Stress: Psychological group intervention with 3 sessions of 60 min (Odenwald & Semrau, 2012). Contains psychoeducation on alcohol drinking related to stress and PTSD.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Cognitive Training: Psychological group intervention with 3 sessions of 60 min. The content is paper-and-pencil based cognitive training of memory and attention functions.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational Group Intervention on Alcohol Drinking Related to Stress
Intervention Description
Manualized and standardized psychotherapeutic group intervention with three sessions of 60 min duration each which are to be delivered in a one-week period.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Manualized and standardized psychotherapeutic group intervention with three sessions of 60 min duration each which are to be delivered in a one-week period.
Primary Outcome Measure Information:
Title
Questionnaire on Alcohol-related Risk Perception
Description
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).
Time Frame
one week
Secondary Outcome Measure Information:
Title
Treatment completion
Description
Binary variable: The patient regularly completes the residential detox treatment or he/she can prematurely end the treatment (treatment drop out).
Time Frame
One month after study completion
Title
Transfer to subsequent treatment
Description
Binary variable: Patient is directly transferred from detox treatment unit to subsequent alcohol in-patient or day-clinic treatment.
Time Frame
One month after study completion
Title
Alcohol relapse
Description
Drinking alcohol after treatment
Time Frame
four weeks
Title
Readmission to detox treatment
Description
The patient is readmitted to the same alcohol detox treatment unit
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Center for Psychiatry Reichenau
City
Reichenau
ZIP/Postal Code
78467
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22178762
Citation
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.
Results Reference
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Addiction Risk: Psychoeducational Intervention to Change Risk Perception Among Alcohol Patients in Residential Treatment

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