Outpatient Psychotherapeutic Treatment for Alcohol Dependent Individuals With Comorbid Psychiatric Disorders
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Outpatient Cognitive Behavioral Psychotherapy
Outpatient Cognitive Behavioral Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence
Eligibility Criteria
Inclusion Criteria:
- alcohol dependence
- comorbid anxiety or mood disorder
Exclusion Criteria:
- severe mental illness: psychosis, mania, personality disorders
- current suicidality
- non-compliance with appointments during first 5 sessions
Sites / Locations
- University of Konstanz, Outpatient Clinic for Psychotherapy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Outpatient Cognitive Behavioral Psychotherapy
Arm Description
Outpatient Cognitive Behavioral Therapy is a well-known and frequently applied psychotherapy approach that does not need further description.
Outcomes
Primary Outcome Measures
Relapse
We assess whether participants have an alcohol relapse (any drinking of alcohol) in the three months after study inclusion
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02141789
Brief Title
Outpatient Psychotherapeutic Treatment for Alcohol Dependent Individuals With Comorbid Psychiatric Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Outpatient Cognitive Behavioral Psychotherapy
Arm Type
Experimental
Arm Description
Outpatient Cognitive Behavioral Therapy is a well-known and frequently applied psychotherapy approach that does not need further description.
Intervention Type
Behavioral
Intervention Name(s)
Outpatient Cognitive Behavioral Psychotherapy
Intervention Description
Integrated CBT intervention for alcohol dependence and comorbid psychiatric disorder (we include only patients with comorbid mood or anxiety disorders).
Intervention Type
Behavioral
Intervention Name(s)
Outpatient Cognitive Behavioral Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relapse
Description
We assess whether participants have an alcohol relapse (any drinking of alcohol) in the three months after study inclusion
Time Frame
3 months
Title
Days with heavy alcohol drinking
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Comorbid psychiatric symptoms
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
alcohol dependence
comorbid anxiety or mood disorder
Exclusion Criteria:
severe mental illness: psychosis, mania, personality disorders
current suicidality
non-compliance with appointments during first 5 sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Odenwald, Dr. rer. nat.
Organizational Affiliation
University of Konstanz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Konstanz, Outpatient Clinic for Psychotherapy
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Learn more about this trial
Outpatient Psychotherapeutic Treatment for Alcohol Dependent Individuals With Comorbid Psychiatric Disorders
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