Alcoholic Intoxication, ChronicNCT01323738
Effect of Psychoeducation on Motivation to Change in Traumatized Alcoholics
A study testing Psychoeducation in people with Alcoholic Intoxication, Chronic, run by University of Konstanz at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholic Intoxication, Chronic
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcohol Dependence
- Regular admission to detoxification unit
Who cannot join
- Severe withdrawal
- Severe cognitive impairment
- Severe comorbid psychiatric conditions (schizophrenia, suicidal crisis)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Alcoholic Intoxication, Chronic
- Being tested
- Psychoeducation
- Keywords
- Psychoeducation, Group Control
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
Also called 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 group on stress and how it relates to alcohol use, 4 sessions a 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Ususal | No intervention | Patients participate in the Treatment as Usual including a non-specific information group. |
| Psychoeducation | Experimental | Intervention group Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 15 days (average treatment duration)
Secondary outcomes (1)
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.
Measured: between admission and discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Intoxication, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Investigators
- Michael Odenwald, PhD, Principal investigator, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323738
- Sponsor's protocol ID
- UKonstanzMOdenwald2009-1
- Status last verified
- Mar 2011
- First submitted
- 22 Dec 2009
- Last updated
- 31 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psychoeducation on Motivation to Change in Traumatized Alcoholics
- ClinicalTrials.gov ID
- NCT01323738
- Acronym / sponsor ID
- UKonstanzMOdenwald2009-1
- Conditions
- Alcoholic Intoxication, Chronic
- Keywords
- Psychoeducation, Group Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Ususal | No intervention | –Patients participate in the Treatment as Usual including a non-specific information group. |
| Psychoeducation | Experimental | Behavioral: PsychoeducationIntervention group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Alcohol Dependence
- Regular admission to detoxification unit
Key exclusion criteria (3 listed)
- Severe withdrawal
- Severe cognitive impairment
- Severe comorbid psychiatric conditions (schizophrenia, suicidal crisis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationAlso: 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 group on stress and how it relates to alcohol use, 4 sessions a 45 minutes | Behavioural | Psychoeducation |
Primary outcome
University of Rhode Island Change Assessment (URICA)
Time frame: Pre and Post (day 1, day 15 (average))
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.
Detoxification treatment completion
Time frame: 15 days (average treatment duration)
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.
number of days in detoxification treatment
Time frame: 15 days (average treatment duration)
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
1 secondary outcome
adverse events
Time frame: between admission and discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Odenwald, PhD principal investigator
University of Konstanz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Alcoholic Intoxication, Chronic, run by University of Konstanz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of Rhode Island Change Assessment (URICA) (time frame: Pre and Post (day 1, day 15 (average))). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2011.