Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01323738
Other study ID # UKonstanzMOdenwald2009-1
Secondary ID
Status Completed
Phase N/A
First received December 22, 2009
Last updated March 30, 2011
Start date January 2010
Est. completion date March 2010

Study information

Verified date March 2011
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority Germany: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Alcohol Dependence

- Regular admission to detoxification unit

Exclusion Criteria:

- Severe withdrawal

- Severe cognitive impairment

- Severe comorbid psychiatric conditions (schizophrenia, suicidal crisis)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

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

Locations

Country Name City State
Germany Center for Psychiatry Reichenau Reichenau

Sponsors (1)

Lead Sponsor Collaborator
University of Konstanz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)) No
Primary 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) No
Primary 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) No
Secondary adverse events Adverse events were assessed during the detoxification treatment for patients taking part in the information group (TAU) or TARGET group (intervention), i.e. suicide attempts, psychiatric decompensation, aggressive behaviors, relapse of alcohol use. These events were recorded by the social worker who participated routinely in the three daily team meetings during which the situation of each patient was briefly discussed. between admission and discharge Yes
See also
  Status Clinical Trial Phase
Completed NCT00372749 - Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients? N/A
Completed NCT02505126 - A Clinical Trial on the Efficacy of tDCS) in Reducing Alcohol Consumption in Non-abstinent Patients (REDSTIM) N/A