NCT01323738

Brief Summary

Many people suffering from alcohol dependence have a history of exposure to stressful life situations, such as childhood physical or emotional misuse. Often, there's a functional relationship between drinking and emotional problems related to past traumatic experiences, i.e. drinking to forget. However, alcohol treatment often does not include interventions to support patients to cope better with past life experiences. On the other hand, most alcoholics are poorly motivated to participate in long-term rehabilitative treatments after detoxification. In the proposed study, the investigators will study the effects of a brief psycho-educational group intervention during detoxification treatment on motivation to change and the willingness to accept further treatment. The investigators will use a group comparison design (intervention versus "TAS" control group). In month 1, patients take part in Treatment as Usual (TAS), including a unspecific information group. In month 2, the information group is replaced by the psychoeducational group (intervention). Ward staff selects patients for the groups, irrespective of intervention or TAS. Selection criteria are: absence of severe withdrawal and cognitive impairment. Absence of severe co-morbid psychiatric disorder (e.g. schizophrenia or suicidal crisis). The group sessions will take place in groups of up to 15 patients and will include 4 structured sessions (45 min each). Main content if the intervention group is to highlight and discuss the association between stress, Posttraumatic Stress Disorder and drinking. Patients will also be informed about the different treatment options available in the region. At entry, patients are asked to fill in the German versions of the University of Rhode Island Change Assessment (URICA; McConnaughy, Prochaska, \& Velicer, 1983; German: Heidenreich, Hoyer \& Fecht; 2001) and the Trauma History Questionnaire (THQ; Green, 1996; German: Maercker, 2002). At discharge, patients are asked to fill in the URICA. The investigators expect that specific information on the association between stress and drinking will increase the patients' motivation to participate in further treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 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

December 22, 2009

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
Last Updated

March 31, 2011

Status Verified

March 1, 2011

Enrollment Period

2 months

First QC Date

December 22, 2009

Last Update Submit

March 30, 2011

Conditions

Keywords

PsychoeducationGroup Control

Outcome Measures

Primary Outcomes (3)

  • University of Rhode Island Change Assessment (URICA)

    Pre-assessment is at entry in in-patient alcohol detoxification treatment, post-assessment is at day of discharge. On average, the two measurements are 15 days apart.

    Pre and Post (day 1, day 15 (average))

  • Detoxification treatment completion

    It was evaluated how many subjects in both treatment arms and among traumatized and non-traumatized in each arm ended the detoxification treatment prematurely, i.e. discharge against medical advice or disciplinary discharge.

    15 days (average treatment duration)

  • number of days in detoxification treatment

    The number of days in detoxification treatment is a simple count of days of treatment between day of detoxification treatment entry and day of discharge

    15 days (average treatment duration)

Secondary Outcomes (1)

  • adverse events

    between admission and discharge

Study Arms (2)

Treatment as Ususal

NO INTERVENTION

Patients participate in the Treatment as Usual including a non-specific information group.

Psychoeducation

EXPERIMENTAL

Intervention group

Behavioral: Psychoeducation

Interventions

PsychoeducationBEHAVIORAL

Psychoeducation group on stress and how it relates to alcohol use, 4 sessions a 45 minutes

Also known as: The manualized group intervention we developed for this study recently was named TARGET,, which reads as "Trauma- and Alcohol-Related Group Education and motivation Therapy"
Psychoeducation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Alcohol Dependence
  • Regular admission to detoxification unit

You may not qualify if:

  • Severe withdrawal
  • Severe cognitive impairment
  • Severe comorbid psychiatric conditions (schizophrenia, suicidal crisis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Psychiatry Reichenau

Reichenau, 78479, Germany

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Michael Odenwald, PhD

    University of Konstanz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2009

First Posted

March 28, 2011

Study Start

January 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 31, 2011

Record last verified: 2011-03

Locations