NCT03339674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

1.7 years

First QC Date

May 10, 2017

Last Update Submit

April 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Treatment completion

    One month after study completion

  • Transfer to subsequent treatment

    One month after study completion

  • Alcohol relapse

    four weeks

  • Readmission to detox treatment

    six months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

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

Manualized and standardized psychotherapeutic group intervention with three sessions of 60 min duration each which are to be delivered in a one-week period.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Alcohol Dependence (according to ICD-10)

You may not qualify if:

  • treatment episode is acute crisis intervention
  • acute psychosis
  • acute suicidality
  • no command of German language (reading writing)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Psychiatry Reichenau

Reichenau, 78467, Germany

Location

Related 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.

    PMID: 22178762BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

EthanolCognitive Training

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Psychotherapy Outpatient Clinic

Study Record Dates

First Submitted

May 10, 2017

First Posted

November 13, 2017

Study Start

November 1, 2017

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations