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

April 23, 2020 updated by: Michael Odenwald, University of Konstanz

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Reichenau, Germany, 78467
        • Center for Psychiatry Reichenau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
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.
Active Comparator: Control
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire on Alcohol-related Risk Perception
Time Frame: one week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment completion
Time Frame: One month after study 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
Transfer to subsequent treatment
Time Frame: One month after study completion
Binary variable: Patient is directly transferred from detox treatment unit to subsequent alcohol in-patient or day-clinic treatment.
One month after study completion
Alcohol relapse
Time Frame: four weeks
Drinking alcohol after treatment
four weeks
Readmission to detox treatment
Time Frame: six months
The patient is readmitted to the same alcohol detox treatment unit
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Konstanz

Collaborators

Centre for Psychiatry Reichenau, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 10, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OD 113/2-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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