Alcohol Use DisorderNCT03339674
Addiction Risk: Psychoeducational Intervention to Change Risk Perception Among Alcohol Patients in Residential Treatment
A study testing Psychoeducational Group Intervention on Alcohol Drinking Related to Stress and Cognitive Training in people with Alcohol Use Disorder, run by University of Konstanz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Psychoeducational Group Intervention on Alcohol Drinking Related to Stress and Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 31 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcohol Dependence (according to ICD-10)
Who cannot join
- treatment episode is acute crisis intervention
- acute psychosis
- acute suicidality
- no command of German language (reading writing)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Psychoeducational Group Intervention on Alcohol Drinking Related to Stress, Cognitive Training
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational Group Intervention on Alcohol Drinking Related to StressBehavioural
Manualized and standardized psychotherapeutic group intervention with three sessions of 60 min duration each which are to be delivered in a one-week period.
Cognitive TrainingBehavioural
Manualized and standardized psychotherapeutic group intervention with three sessions of 60 min duration each which are to be delivered in a one-week period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one week
Secondary outcomes (4)
Treatment completion
Binary variable: The patient regularly completes the residential detox treatment or he/she can prematurely end the treatment (treatment drop out).
Measured: One month after study completion
Transfer to subsequent treatment
Binary variable: Patient is directly transferred from detox treatment unit to subsequent alcohol in-patient or day-clinic treatment.
Measured: One month after study completion
Alcohol relapse
Drinking alcohol after treatment
Measured: four weeks
Readmission to detox treatment
The patient is readmitted to the same alcohol detox treatment unit
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Nov 2017
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Psychiatry Reichenau, Germany
- Responsible party
- Principal investigator, Michael Odenwald, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339674
- Sponsor's protocol ID
- OD 113/2-1
- Status last verified
- Apr 2020
- First submitted
- 10 May 2017
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22178762
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03339674
- Acronym / sponsor ID
- OD 113/2-1
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- Centre for Psychiatry Reichenau, Germany
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Nov 2017 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Psychoeducational Group Intervention on Alcohol Drinking Related to StressPsychoeducational 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. |
| Control | Active comparator | Behavioral: Cognitive TrainingCognitive Training: Psychological group intervention with 3 sessions of 60 min. The content is paper-and-pencil based cognitive training of memory and attention functions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Alcohol Dependence (according to ICD-10)
Key exclusion criteria (4 listed)
- treatment episode is acute crisis intervention
- acute psychosis
- acute suicidality
- no command of German language (reading writing)
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 |
|---|---|---|
| Psychoeducational Group Intervention on Alcohol Drinking Related to StressManualized and standardized psychotherapeutic group intervention with three sessions of 60 min duration each which are to be delivered in a one-week period. | Behavioural | Intervention |
| Cognitive TrainingManualized and standardized psychotherapeutic group intervention with three sessions of 60 min duration each which are to be delivered in a one-week period. | Behavioural | Control |
Primary outcome
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).
4 secondary outcomes
Treatment completion
Time frame: One month after study completion
Transfer to subsequent treatment
Time frame: One month after study completion
Alcohol relapse
Time frame: four weeks
Readmission to detox treatment
Time frame: six months
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 24 Apr 2020.
- Background: PubMed 22178762Odenwald 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational Group Intervention on Alcohol Drinking Related to Stress and Cognitive Training in people with Alcohol Use Disorder, 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 1 inclusion and 4 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 24 Apr 2020. 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?
Questionnaire on Alcohol-related Risk Perception (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339674, which also lists 1 linked publication.
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 24 Apr 2020.