Alcohol DependenceNCT02141789
Outpatient Psychotherapeutic Treatment for Alcohol Dependent Individuals With Comorbid Psychiatric Disorders
A study testing Outpatient Cognitive Behavioral Psychotherapy in people with Alcohol Dependence, run by University of Konstanz at 1 site in Germany.
Trial summary
Research has shown that alcohol dependence often co-occurs with comorbid anxiety disorders and/or depression. Anxiety and depression influence the course and treatment of alcohol dependence and are a major risk factor for alcohol relapse within the first three months after detoxification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Outpatient Cognitive Behavioral Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to Mar 2018
- 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
- comorbid anxiety or mood disorder
Who cannot join
- severe mental illness: psychosis, mania, personality disorders
- current suicidality
- non-compliance with appointments during first 5 sessions
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Konstanz, Outpatient Clinic for Psychotherapy
Konstanz, 78464
About this study
Research has shown that alcohol dependence often co-occurs with comorbid anxiety disorders and/or depression. Anxiety and depression influence the course and treatment of alcohol dependence and are a major risk factor for alcohol relapse within the first three months after detoxification. Therefore, there is need for combined treatment (integrated therapy) of alcohol dependence and comorbid psychiatric disorders, e.g. anxiety and/or depression. Until today, there are no systematic outpatient treatment offers for this special group of patients in Germany. In this study we want to investigate if integrated outpatient cognitive behavioral therapy can prevent and decrease alcohol relapse within the first three months after detoxification. Therefore we hypothesize that immediate start of integrated outpatient psychotherapy will reduce relapse variables compared to treatment as usual which is characterized by non-immediate start of therapy due to the required application for insurance coverage.
- Conditions
- Alcohol Dependence
- Being tested
- Outpatient Cognitive Behavioral Psychotherapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Cognitive Behavioral PsychotherapyBehavioural
Integrated CBT intervention for alcohol dependence and comorbid psychiatric disorder (we include only patients with comorbid mood or anxiety disorders).
Outpatient Cognitive Behavioral PsychotherapyBehavioural
The intervention is a well established form of psychotherapy that has infrequently been used in the German system with this group of patients in contrast to many other countries where it is the standard approach, e.g. the US.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Cognitive Behavioral Psychotherapy | Experimental | Outpatient Cognitive Behavioral Therapy is a well-known and frequently applied psychotherapy approach that does not need further description. Receives: Behavioral: Outpatient Cognitive Behavioral Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
We assess whether participants have an alcohol relapse (any drinking of alcohol) in the three months after study inclusion
Measured: 3 months
Days with heavy alcohol drinking
We assess with the Timeline Follow Back (TLFB, Sobell \& Sobell, 2000) the number of days with heavy alcohol drinking (for a man 5 or more drinks a day, for a woman 4 or more drinks a day) in the three months after study inclusion
Measured: 3 months
Secondary outcomes (1)
Comorbid psychiatric symptoms
Anxiety, depression and other relevant psychiatric symptoms will be measured by different standardized questionnaires at t1 (before treatment) and after 3 months (t2). We will use standardized symptom change as outcome measure.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2017
- Study completionMar 2018
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 DependenceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Odenwald, University of Konstanz
- Investigators
- Michael Odenwald, Dr. rer. nat., Principal investigator, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141789
- Sponsor's protocol ID
- UKonstanzMOdenwald2014-1
- Status last verified
- Mar 2020
- First submitted
- 15 May 2014
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Schawohl A, Adam M, Odenwald M. What's Next After Withdrawal Treatment? A Randomized Controlled Pilot Study on Integrated Outpatient Psychotherapy in Alcohol-Dependent Patients With Dual Diagnoses. Zeitschrift für Klinische Psychologie und Psychotherapie. 2018; 47(3): 153-162. doi: 10.1026/1616-3443/a000487
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Psychotherapeutic Treatment for Alcohol Dependent Individuals With Comorbid Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT02141789
- Acronym / sponsor ID
- UKonstanzMOdenwald2014-1
- Conditions
- Alcohol Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 19 May 2014 (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.
Research has shown that alcohol dependence often co-occurs with comorbid anxiety disorders and/or depression. Anxiety and depression influence the course and treatment of alcohol dependence and are a major risk factor for alcohol relapse within the first three months after detoxification. Therefore, there is need for combined treatment (integrated therapy) of alcohol dependence and comorbid psychiatric disorders, e.g. anxiety and/or depression. Until today, there are no systematic outpatient treatment offers for this special group of patients in Germany. In this study we want to investigate if integrated outpatient cognitive behavioral therapy can prevent and decrease alcohol relapse within the first three months after detoxification. Therefore we hypothesize that immediate start of integrated outpatient psychotherapy will reduce relapse variables compared to treatment as usual which is characterized by non-immediate start of therapy due to the required application for insurance coverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatient Cognitive Behavioral Psychotherapy | Experimental | Behavioral: Outpatient Cognitive Behavioral PsychotherapyOutpatient Cognitive Behavioral Therapy is a well-known and frequently applied psychotherapy approach that does not need further description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- alcohol dependence
- comorbid anxiety or mood disorder
Key exclusion criteria (3 listed)
- severe mental illness: psychosis, mania, personality disorders
- current suicidality
- non-compliance with appointments during first 5 sessions
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 |
|---|---|---|
| Outpatient Cognitive Behavioral PsychotherapyIntegrated CBT intervention for alcohol dependence and comorbid psychiatric disorder (we include only patients with comorbid mood or anxiety disorders). | Behavioural | Outpatient Cognitive Behavioral Psychotherapy |
| Outpatient Cognitive Behavioral PsychotherapyThe intervention is a well established form of psychotherapy that has infrequently been used in the German system with this group of patients in contrast to many other countries where it is the standard approach, e.g. the US. | Behavioural | Outpatient Cognitive Behavioral Psychotherapy |
Primary outcome
Relapse
Time frame: 3 months
We assess whether participants have an alcohol relapse (any drinking of alcohol) in the three months after study inclusion
Days with heavy alcohol drinking
Time frame: 3 months
We assess with the Timeline Follow Back (TLFB, Sobell \& Sobell, 2000) the number of days with heavy alcohol drinking (for a man 5 or more drinks a day, for a woman 4 or more drinks a day) in the three months after study inclusion
1 secondary outcome
Comorbid psychiatric symptoms
Time frame: 3 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 25 Mar 2020.
- Results publicationSchawohl A, Adam M, Odenwald M. What's Next After Withdrawal Treatment? A Randomized Controlled Pilot Study on Integrated Outpatient Psychotherapy in Alcohol-Dependent Patients With Dual Diagnoses. Zeitschrift für Klinische Psychologie und Psychotherapie. 2018; 47(3): 153-162. doi: 10.1026/1616-3443/a000487
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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, Dr. rer. nat. 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 Outpatient Cognitive Behavioral Psychotherapy in people with Alcohol Dependence, 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 25 Mar 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?
Relapse (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT02141789, 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 25 Mar 2020.